Developing practice recommendations for endovascular ... · Embolus Removal in Cerebral Ischemia (MERCI) and Multi-MERCI were prospective, single-arm, ... Randomized Clinical trial

Developing practice recommendations forendovascular revascularization for acuteischemic stroke

Marc A Lazzaro MDRoberta L Novakovic

MDAndrei V Alexandrov

MDZiad Darkhabani MDRandall C Edgell MDJoey English MDDonald Frei MDDara G Jamieson MDVallabh Janardhan MDNazli Janjua MDRashid M Janjua MDIrene Katzan MDPooja Khatri MDJawad F Kirmani MDDavid S Liebeskind

MDItalo Linfante MDThanh N Nguyen MDJeffrey L Saver MDLori Shutter MDAndrew Xavier MDDileep Yavagal MDOsama O Zaidat MD

ABSTRACT

Guidelines have been established for the management of acute ischemic stroke however spe-cific recommendations for endovascular revascularization therapy are lacking Burgeoning inves-tigation of endovascular revascularization therapies for acute ischemic stroke rapid devicedevelopment and a diverse training background of the providers performing the procedures un-derscore the need for practice recommendations This review provides a concise summary of theSociety of Vascular and Interventional Neurology endovascular acute ischemic stroke roundtablemeeting This document was developed to review current clinical efficacy of pharmacologic andmechanical revascularization therapy selection criteria periprocedure management and endo-vascular time metrics and to highlight current practice patterns It therefore provides an outlinefor the future development of multisociety guidelines and recommendations to improve patientselection procedural management and organizational strategies for revascularization therapiesin acute ischemic stroke Neurologyreg 201279 (Suppl 1)S243ndashS255

GLOSSARYACT activated clotting time AHA American Heart Association AIS acute ischemic stroke ASA American StrokeAssociation ASPECTS Alberta Stroke Program Early CT score CI confidence interval ECASS European CooperativeAcute Stroke Study III ED emergency department EMS emergency medical services ERT endovascular revascular-ization therapy FDA US Food and Drug Administration IA intra-arterial ICH intracranial hemorrhage IMS Interven-tional Management of Stroke J-MUSIC Japan Multicenter Stroke Investigatorsrsquo Collaboration MCA middle cerebralartery MELT MCA-Embolism Local fibrinolytic intervention Trial MERCI Mechanical Embolus Removal in CerebralIschemia MR CLEAN Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in theNetherlands MR RESCUE MR and Recanalization of Stroke Clots Using Embolectomy mRS modified Rankin ScaleNIHSS NIH Stroke Scale NINDS National Institute of Neurological Disorders and Stroke OR odds ratio PROACT Prolyse in Acute Cerebral Thromboembolism rtPA recombinant tissue plasminogen activator sICH symptomatic ICHSYNTHESIS EXP Intra-Arterial Versus Systemic Thrombolysis for Acute Ischemic Stroke THERAPY Assess the Penum-bra System in the Treatment of Acute Stroke VBO vertebrobasilar occlusion

In an effort to improve outcome in patients with acute ischemic stroke (AIS) recent initiativeshave outlined the best medical management and developed protocols to facilitate timely iden-tification and administration of the US Food and Drug Administration (FDA)ndashapproved IVrecombinant tissue plasminogen activator (rtPA) to eligible patients12

Restoration of blood flow after AIS is associated with improved outcome and reducedmortality34 A meta-analysis including over 2000 patients in 53 studies confirmed a strongcorrelation between recanalization and good functional outcome at 3 months in comparisonwith nonrecanalization (odds ratio [OR] 443 95 confidence interval [CI] 332ndash591)4

Intra-arterial (IA) thrombolysis has not received FDA approval but randomized trials andseveral case series have led to endorsements by multiple associations for select patients5ndash9

Endovascular revascularization therapy (ERT) currently has a Class Ib recommendation for IAthrombolysis for select patients and a Level IIb recommendation for mechanical thrombus

From the Medical College of WisconsinFroedtert Hospital (MAL ZD OOZ) Milwaukee WI University of Texas Southwestern MedicalCenter at Dallas (RLN) Dallas University of Alabama (AVA) Birmingham St Louis University (RCE) St Louis MO University ofCalifornia San Francisco (JE) San Francisco Radiology Imaging Associates (DF) Denver CO Weill Cornell Medical College (DGJ) New YorkNY Texas Stroke Institute (VJ) Dallas Asia Pacific Comprehensive Stroke Institute (NJ) Pahoa HI Wake Forest Baptist Health (RMJ)Winston-Salem NC Cleveland Clinic Foundation (IK) Cleveland OH University of Cincinnati (PK LS) Cincinnati OH New JerseyNeuroscience Institute (JFK) JFK Medical Center Edison University of California Los Angeles (DSL JLS) Los Angeles Baptist MedicalCenter (IL) Miami FL Boston University Medical Center (TNJ) Boston MA Wayne State University (AX) Detroit MI and University ofMiami (DY) Miami FL

Go to Neurologyorg for full disclosures Disclosures deemed relevant by the authors if any are provided at the end of this article

Correspondence amp reprintrequests to Dr NovakovicRobinNovakovicUTSouthwesternedu

copy 2012 American Academy of Neurology S243

extraction in the American Heart Association(AHA) guidelines1ndash9 Two device familieshave FDA approval for ERT the Merci Re-triever (Concentric Medical Inc MountainView CA) and the Penumbra Aspiration Sys-tem (Penumbra Inc Alameda CA) andmultiple new devices are rapidly approachingFDA approval and market availability1011 Es-tablished guidelines and recommendationsare available for the early treatment of adultswith AIS1 and for the development of com-prehensive stroke centers7 and training stan-dards for endovascular ischemic stroketreatment9 However guidelines for ERT forAIS are lacking Ongoing clinical trials andthe brisk pace of emerging technologies havefostered enthusiasm for endovascular therapyfor AIS resulting in the need for developmentof practice recommendations

This outline was developed by a panel ofphysicians with a range of expertise in neuro-interventional procedures vascular neurol-ogy neurocritical care neurosurgery andneuroradiology In many instances definitiveclinical trialndashbased data are lacking and prac-tices are discussed on the basis of pathophysi-ologic rationale and expert opinion not onthe basis of randomized clinical trials

SAFETY AND EFFICACY OF ENDOVASCULARREVASCULARIZATION THERAPY FOR ACUTEISCHEMIC STROKE Endovascular treatment op-tions for intracerebral revascularization have evolvedconsiderably over the past decade Several trials eval-uating the various therapies are summarized in table1 The Prolyse in Acute Cerebral Thromboembolism(PROACT) and PROACT II studies evaluated theuse of IA thrombolysis with prourokinase in middlecerebral artery (MCA) occlusions56 The initial phase2 trial demonstrated higher recanalization rates withprourokinase5 The phase 3 trial PROACT II dem-onstrated the effectiveness of IA thrombolysis withprourokinase in patients with an MCA occlusiontreated within 6 hours from symptom onset6 A min-imum requirement NIH Stroke Scale (NIHSS) scoreof 4 except for isolated aphasia or hemianopia wasrequired for enrollment Patients treated with prou-rokinase had a higher rate of recanalization (66 vs18 p 0001) and were more likely to have agood outcome (modified Rankin Scale [mRS] scoreof 0ndash2 at 90 days 40 vs 25 p 004) despite ahigher rate of symptomatic intracranial hemor-rhage (sICH) (10 vs 2 p 006) The MCA-

Embolism Local fibrinolytic intervention Trial(MELT) was a similarly designed trial comparingurokinase to placebo in patients with MCA occlu-sions which was terminated early because of the ap-proval of the IV administration of rtPA in Japan12

Although the MELT findings are underpowered theresults are consistent with those of the PROACT tri-als suggesting higher recanalization rates (74) withIA thrombolysis12 A meta-analysis of these 3 trialsand 2 additional smaller trials combined 395 ran-domized patients and showed that IA thrombolysisincreased the odds of both nondisabled outcome(mRS score 0ndash1 OR 25 95 CI 133ndash314 p

0001) and nondependent outcome (mRS score 0ndash2OR 14 95 CI 131ndash351 p 0003)13 A case-control analysis from Japanrsquos Multicenter Stroke In-vestigatorsrsquo Collaboration (J-MUSIC) compared 91patients with an acute cardioembolic stroke treatedwith IA urokinase within 45 hours of symptom on-set to a matched control group that did not receiveIA therapy The analysis showed that a favorable out-come (mRS score of 0 ndash2) was more frequentlyobserved in the urokinase group (505 vs 341p 00124) and there was no difference in mortal-ity rate14 Although confirmatory trials required forFDA approval of IA therapy have not been per-formed these randomized trials and numerous caseseries support the use of IA thrombolysis in selectpatients who are ineligible for IV thrombolysis

Mechanical devices for ERT have evolved as ameans of achieving faster rates of recanalization inmedium- to large-vessel occlusions The MechanicalEmbolus Removal in Cerebral Ischemia (MERCI)and Multi-MERCI were prospective single-armmulticenter trials designed to test the efficacy andsafety of a corkscrew thrombectomy device in thetreatment of medium- to large-vessel occlusions (an-terior and posterior circulation) within 8 hours ofsymptom onset10 A combined analysis of the 2 stud-ies demonstrated a successful recanalization rate (de-fined as Thrombolysis in Myocardial Infarction 2 or3 score) of 646 with good clinical outcome (mRSscore of 0ndash2) in 324 despite an sICH rate of78 in the first study and 98 in the second15

The Penumbra Pivotal Stroke Trial provided registrydata on a novel aspiration-thrombectomy device thePenumbra system used within 8 hours for large-artery cerebrovascular occlusion11 A quarter of thepatients achieved an mRS score of less than or equalto 2 at 90 days Different techniques for measuringrecanalization preclude a direct comparison betweenthe rates achieved with MERCI and Penumbra butboth exceed the natural history rate16

Randomized trials are ongoing such as the LocalVersus Systemic Thrombolysis for Acute Ischemic

S244 Neurology 79 (Suppl 1) September 25 2012

Stroke (SYNTHESIS EXP) and the MulticenterRandomized Clinical trial of Endovascular treatmentfor Acute ischemic stroke in the Netherlands (MRCLEAN) comparing endovascular recanalization vsstandard medical treatment alone (including IV rtPAor supportive care alone)1718 The NIH-funded Me-chanical Retrieval and Recanalization of Stroke ClotsUsing Embolectomy (MR RESCUE) trial is compar-ing the effectiveness of endovascular therapy within 8hours of symptom onset and standard medical careto standard medical treatment alone19 Several trialsare testing bridging therapies combining early ad-ministration of IV rtPA with the endovascular ap-proach including the Interventional Management ofStroke III (IMS III) and Assess the Penumbra Systemin the Treatment of Acute Stroke (THERAPY) tri-als20 In the United States the ongoing IMS a ran-domized multicenter trial will enroll 900 subjectswith AIS within 3 hours of symptom onset to com-pare combined IV and IA rtPA to IV rtPA alone21

Alternative revascularization methods continue toevolve and have included acute intracranial stent im-plantation22 and temporary endovascular bypass andthrombectomy with a retrievable stent2324 Initialopen series reports with stent retrievers suggest po-tentially higher recanalization rates and shorter pro-cedure times

PATIENT SELECTION FOR ENDOVASCULARREVASCULARIZATION THERAPY IN ACUTEISCHEMIC STROKE Designing a decision algo-rithm for patient selection for ERT in AIS is hin-dered by variable enrollment criteria in the trialscited previously The presented outline for the devel-opment of a decision algorithm is based on findingsfrom available randomized controlled trials and ex-trapolated from criteria from recent and ongoingclinical trials (figure) This is an example of one pos-sible algorithm and further investigation is necessaryprior to clinical use

Outside of clinical trials IV therapy remains first-line treatment for eligible patients presenting withclinical symptoms of AIS Through a systematic re-view of the literature the American Stroke Associa-tion (ASA) guidelines outline the best medicalmanagement as well as protocols to facilitate timelyadministration of IV rtPA to patients eligible forthrombolysis1 For patients with moderate to severedeficits and minimal or no early ischemic changes onbrain imaging therapy triage is largely governed bytime from symptom onset There is strong evidencefrom multiple clinical trials to support the use of IVrtPA within 3 hours22526 Current FDA approvalexists for patients presenting up to 3 hours fromsymptom onset and a science advisory from theASAAHA has recommended expanding the time

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Neurology 79 (Suppl 1) September 25 2012 S245

window to 45 hours in a subgroup of patients onthe basis of results of the European CooperativeAcute Stroke Study III (ECASS III)2527

Patients presenting after 45 hours are not eligiblefor systemic thrombolysis however data exist ascited previously for the consideration of IA fibrino-lytic administration up to 6 hours from symptomonset in patients with a large- to medium-vessel oc-clusion61228 For patients in whom endovasculartherapy can be initiated within 8 hours from symp-tom onset 2 mechanical revascularization devicefamilies have demonstrated safe and feasible rates ofrecanalization in single-arm prospective trials101129

The optimal device for mechanical revascularizationhas not been identified and the rapid growth of de-vice technology will likely continue to challenge rig-orous clinical evaluation

Vertebrobasilar artery occlusion (VBO) has an in-variably poor outcome if recanalization is notachieved early The recent literature shows that mor-tality with acute VBO treated with nonthrombolyticdrugs is 80 to 90 although lower rates of 42 to60 can be achieved with IA therapy283031 Successof recanalization and neurologic status before treat-ment are independent predictors of a favorable out-come after IA therapy3031 Multiple studies failed toestablish a time window that would definitively ex-

clude patients from IA therapy30 One study found asignificantly better clinical outcome in patients withacute VBO treated within 6 hours after symptomonset than in patients treated after 6 hours (favorableoutcome of 36 vs 7 mortality of 52 vs 70p 0005)28 Other studies demonstrated trends to-ward better outcome with shorter duration of symp-toms and no significant association between time totreatment and clinical outcome3031 When patients arein a coma or have had prolonged symptoms additionalimaging such as MRI with diffusion and perfusion orCT perfusion might help in identifying those who arelikely to benefit from intervention However the cur-rent application of CT perfusion results to the posteriorcirculation may be limited

The trials that shape the current decision patternshave been largely based on time from symptom on-set Data are lacking on the efficacy of ERT beyond12 hours from symptom onset in patients with poste-rior circulation occlusion and beyond 8 hours in an-terior circulation occlusion1011293132 Given the poornatural history of VBO revascularization has beenconsidered beyond 12 hours from symptom onsetEnthusiasm continues for a perfusion imagingndashbaseddecision algorithm although rigorous data to sup-port this approach are lacking33 Further study ofperfusion imaging may assist with selection of pa-

Figure Possible decision algorithm for revascularization therapies in acute ischemic stroke


tients who would benefit from revascularization be-yond 8 hours34

At the very least noncontrast head CT ordiffusion- and susceptibility-weighted MRI are re-quired to exclude hemorrhage and identify early isch-

emic changes that could pose increased hemorrhagicrisk following revascularization Larger regions ofwell-defined hypoattenuation (CT) or hyperintensity(MRI) indicating infarcted tissue may carry a consid-erably higher risk of hemorrhage following revascu-larization Careful consideration may be needed forpatients with CT hypodensity or MRI hyperintensityin greater than 13 of the MCA territory or withprominent sulcal effacement35 Alternative standard-ized scoring systems may include the Alberta StrokeProgram Early CT Score (ASPECTS)36

Future studies may show that for patients whoreceive IV rtPA and have a clinical presentation sug-gestive of a large-vessel occlusion early considerationof ERT may be important The limited efficacy of IVrtPA in large vessel occlusions is demonstrated byrecanalization rates as low as 30 in the proximalMCA and 6 in the terminal internal carotid artery(ICA)37 Urgent noninvasive vascular imaging canidentify patients with a large-vessel occlusion Theinterval from a decision to pursue IA intervention toreaching the clot can be long with time required toobtain consent transport and prepare the patient andnegotiate tortuous anatomy Accordingly an efficientstrategy may be to activate the neurointerventional teamwhen a large-vessel occlusion is suspected without delayin IV rtPA initiation If dramatic clinical improvementoccurs patients can be rerouted to repeat noninvasivevessel assessment One retrospective study has shownthat in those patients with a contraindication to IV rtPAor whose IV therapy fails the use of ERT within thefirst 3 hours after stroke symptom onset has a low sICHrate of 5338

Patients with fluctuating deficits or continuedmild deficits (NIHSS score 4) following rapid im-provement from presentation carry a risk of harbor-ing a large-vessel occlusion with tenuous collateralsupply Failure of collateral supply could lead toacute deterioration therefore emergent noninvasiveangiography to identify vessel occlusions amenable toERT may be considered To date no randomizedclinical trial has compared the natural history ofmedical treatment alone to early recanalization withERT in this subset of patients

For patients in whom ERT is considered inclu-sion and exclusion criteria will be needed Based onthe existing clinical trials and guidelines a frame-work for the future development of criteria can beoutlined (table 2)

SELECTION OF ENDOVASCULAR REVASCU-LARIZATION THERAPY TECHNIQUE The heter-ogeneity of AIS characteristics including thrombuscomposition occlusion location thrombus volumeburden and collateral perfusion may demand tai-

Table 2 Possible selection criteria for acute ischemic stroke endovascularrevascularization therapy

Inclusion criteria for ERT

Neurologic deficit attributable to a medium- to large-vessel occlusion

IA chemical thrombolysis can be initiated within 6 h of symptom onset

Mechanical thrombectomy treatment can be initiated within window of 8 h from time of onsetfor anterior circulation strokes

ERT can be initiated within window of 12 h from time of onset for posterior circulationstrokes

Treatment beyond 6ndash8 h may be guided by advanced imaging results (DWI MRI PWI CTP)when available

Potentially disabling neurologic deficit

Persistent or worsening neurological deficits following IV rtPA administration

Exclusion criteria for ERT

Arterial stenosis precluding safe access

Suspicion of aortic dissection

Uncontrolled hypertension defined as systolic blood pressure 185 mm Hg or diastolicblood pressure 110 mm Hg that cannot be reasonably treated with antihypertensivemedication

Platelet count 30000

Use of warfarin anticoagulation with INR 30

Known bleeding diathesis

Deficits attributable to glucose 50 mgdL

Seizure at onset if residual deficits are due to a postictal state rather than ischemia

Imaging findings

Significant mass effect with midline shift

Intracranial hemorrhage (ICH SAH subdural or epidural hematoma)

Subacute infarct on head CTMRI that occupies 13 of the MCA territory or 100 cc ofbrain tissue

CNS lesion with high likelihood of hemorrhage should be excluded from IA pharmacologicthrombolysis (brain tumor abscess vascular malformation aneurysm contusion)

May consider IA thrombolysis in patients with small unruptured aneurysms or benigntumors with low vascularity

Relative contraindications for ERT therapy

Intracranial or spinal surgery head trauma or stroke in separate vascular territory within 3months

History of ICH

Terminal illness with short life expectancy or severe comorbid illness

Pregnancy

Risk vs benefit of clinical symptoms and ability to shield patient must be considered

Known subacute bacterial endocarditis with or without mycotic aneurysm and stroke

Special consideration may be needed for patients on dabigatran

Relative contraindications for adjunctive ERT following IV rtPA

Glucose 400 mgdL based on increased ICH risk

Ongoing hemodialysis or peritoneal dialysis due to possibly increased ICH risk

Abbreviations CTP CT perfusion DWI MRI diffusion-weighted MRI ERT endovascu-lar revascularization therapy IA intra-arterial ICH intracerebral hemorrhage INR

international normalized ratio MCA middle cerebral artery NIHSS NIH Stroke ScalertPA recombinant tissue plasminogen activator SAH subarachnoid hemorrhage


lored interventions For example greater efficacy andsafety may be demonstrated in distal vessel revascu-larization by use of IA fibrinolytic therapy vs a me-chanical device that may be more difficult to deliverAlternatively in large proximal vessel occlusionsgreater benefit may be achieved with mechanicalthrombectomy Furthermore carotid occlusion atthe origin of the ICA may be better treated with bal-loon angioplasty and stent implantation

Pharmacologic thrombolysis Local IA thrombolysisefficacy was demonstrated in PROACT II6 This ledto an AHA Class I level of evidence B recommenda-tion that IA thrombolysis is an option for the treat-ment of selected patients who have AIS under 6hours duration due to occlusions of the MCA andwho are not otherwise candidates for IV rtPA1 Al-though variability in study designs prohibits direct com-parison of the data theoretically there may be a higherrisk of intracerebral hemorrhage (ICH) with chemicalIA thrombolysis than with mechanical revasculariza-tion However increased ICH was not substantiated ina multicenter study39

Microcatheter position during thrombolytic infu-sion may also theoretically affect recanalization ratesThe microcatheter position varies among the studiesin some instances it is placed distal to the thrombuswithin the thrombus or proximal to the thrombusSome operators will use multiple locations to infusertPA throughout the thrombus The maximum safedose for IA rtPA is not known however if we extrap-olate from large clinical trial experience then a max-

imum dose of 22 mg as in the IMS trials may be areasonable initial limit2140

Bridging therapies Bridging therapy trials evaluatingthe combined approach have shown better recanali-zation rates for medium- to large-vessel occlusionsHowever they have shown only trends toward betteroutcomes in comparison with the IV rtPAndashtreatedsubjects in the National Institute of NeurologicalDisorders and Stroke (NINDS) rtPA Stroke Study ora database registry4041 Potential benefit of bridgingtherapy increases when the target population is lim-ited to IV rtPA nonresponders (40 IV-IA patientsreached functional independence at 3 months vs149 of recipients of only IV rtPA among the non-responders [p 0012]) This benefit came at thecost of a higher morbidity associated with the bridg-ing therapy (OR 214 95 CI 058 ndash783 forsICH)42 The early Emergency Management ofStroke Bridging TrialIMS trials used a protocol of06 mgkg IV rtPA with up to an additional maxi-mum of 22 mg IA rtPA which in most patients al-lowed for the total dose to remain below the NINDSmaximum amount of 90 mg (table 3) Howevernewer bridging studies and the amended IMS III areusing full-dose IV rtPA in the combined IV-IA treat-ment arm2021

Mechanical revascularization Mechanical techniquesfor ERT including thrombectomy clot retrievaland thromboaspiration have shown comparable orslightly higher recanalization rates than IA thrombol-

Table 3 Intra-arterial thrombolytic dosing and methods from selected trials

Trial PROACT5 PROACT II6 MELT12 IMS I55 IMS II40 IMS III21

Agent ProUK ProUK UK rtPA rtPA rtPA

Max dose Two-tier dose6 mg and 12 mg

9 mg 600000 IU IV rtPA 06 mgkg 60mg maxIA rtPA 22 mg

IV rtPA 06 mgkg60 mg maxIA rtPA 22 mg

IV rtPA 06 mgkg 60 mgmaxpossibly IA rtPA 22 mg

Median dose mg 6 and 12 9 mdash mdash 12 mdash

Infusion duration h 2 2 2 2 2 2

Infusion location At proximal one-thirdof thrombus

At proximal one-thirdof thrombus

Distal tothrombus

2 mg distal to thrombusthen 2 mg intothrombus then infusion

At site of thrombuswith or withoutEkos ultrasoundcatheter

1 mg distal and 1 mgproximal then 20 mg overmaximum of 2 h

Mechanical disruption Prohibited Prohibited Only withguidewire

Only with guidewire ormicrocatheter

Only with guidewireor microcatheter

Merci device Ekos orpenumbra device with IArtPA infusion ormicrocatheter IA rtPAinfusion

Intraproceduralsystemic thrombo-prophylaxis

Heparin 2000 IUbolus and 500 IUhinfusionfor 4 h


Heparin 5000IU bolus

Heparin 2000 IU bolusand 450 IUh infusion

Heparin 2000 IUbolus and 450 IUhinfusion

Heparin 2000 IU bolus and450 IUh infusion until theend of the procedure

Adjunctiveantithrombotic agents

Prohibited in first24 h


Prohibited infirst 24 h

Prohibited in first 24 h Prohibited in first24 h

Prohibited in first 24 h

Abbreviations IA intra-arterial IMS Interventional Management of Stroke trial IU international units MELT Middle cerebral artery Embolism LocalFibrinolytic intervention Trial PROACT Prolyse in Acute Cerebral Thromboembolism trial rtPA IV recombinant tissue plasminogen activator UK

urokinase


ysis alone (table 1) Newer devices such as the Soli-taire FR retrievable stent (eV3 Irvine CA) haveshown even higher recanalization rates (84ndash90)2324 In appropriately selected patients me-chanical revascularization may theoretically have alower risk of hemorrhagic complications given theabsence or reduced need for a thrombolytic agent Inpatients who are considered for ERT after full-doseIV rtPA a mechanical approach might be favorableLimitations of mechanical revascularization includedevice failure deliverability to distal locations andembolization

Multimodal revascularization Given the heterogene-ity of vessel occlusion etiology in AIS a combinationof multiple techniques may afford the highest successfor revascularization Small series suggest that multi-modal therapies including IA thrombolysis and stentimplantation lead to higher recanalization rates39

Future studies may find mechanical thrombectomyto be more successful in proximal large-vessel occlu-sions whereas local IA thrombolysis would be pre-ferred in distal small-vessel occlusions Also stentimplantation may be most effective for in situ intra-cranial atherosclerosis with supervening thrombosisbut retrieval and aspiration techniques may be moreeffective for thromboemboli occlusive in relativelynormal recipient arteries4

Posterior circulation modality selection The besttreatment modality for patients with VBO remainspoorly defined A large prospective observationalregistry and a separate systematic analysis of pub-lished case series analyzed a total of 1012 patientsboth studies did not support unequivocal superiorityof IA therapy vs IV thrombolysis3243 However theheterogeneity of the data between the patients withinthe groups analyzed limits interpretation of the clini-cal conclusions Early recanalization is an importantprognostic factor for good clinical outcome as suchhigher and safer rates of recanalization are beingachieved with newer therapeutic strategies utilizingmechanical embolectomy devices retrievable stentsangioplasty with or without stenting use of glyco-protein IIbIIIa inhibitors and combinationsthereof2328304445

TARGET TIME INTERVALS AND TRIAGE ANDTRANSFER STRATEGIES Time to revasculariza-tion is an independent predictor of good outcome inpatients with AIS4647 Randomized trials of IV rtPAhave demonstrated the greatest benefit in subjectstreated within 90 minutes of symptom onset225 Re-canalization rates with ERT are higher than with IVrtPA alone although the delay to treatment may at-tenuate the benefit This illustrates the importance ofestablishing benchmark door-to-revascularization

Tab

le4

Tre

atm

ent

tim

esin

sele

cted

stud

ies

inm

inut

es

Tri

alP

RO

AC

T5

PR

OA

CT

II6

IMS

I55IM

SII

I21E

MS

56M

ELT

12R

EC

AN

ALI

SE

41P

enum

bra

PS

T11

Mul

tiM

ER

CI29

M

ER

CI10

Wol

feet

al50

Doc

rocq

etal

54C

osta

lat

etal

43M

iley

etal

53S

uare

zet

al51

Mat

tle

etal

49F

lahe

rty

etal

52

No

ofsu

bje

cts

40

12

16

25

00

35

56

50

12

53

05

96

13

50

91

54

57

44

Tre

atm

ent

IApr

oUK

orpl

aceb

oIA

proU

KIV

-IA

rtP

AIV

aor

IV

IAb

IV-I

Aa

orIA

rtP

Ab

IAU

KIV

-IA

orIV

-IA

Trt

PA

IAT

IV

rtP

AIA

TIV

-IA

aor

IArt

PA

bIA

UK

IV-R

Sor

RS

alon

eIV

-IA

Tor

IAT

IAU

KIA

TU

KIV

IA

rtP

A

Tim

e-to

-doo

r1

14

Tim

e-to

-CT

MR

Isc

anm

ean

(med

ian)

Ons

et1

05

Ons

et1

62

(14

5)

Doo

r5

9(3

4)

Imag

ing

-to-

GP

16

1(1

53

)8

1(6

5)

CT

scan

-to-

mic

roca

thet

er1

74

Tim

e-to

-ER

Tin

itia

tion

oran

gio

gra

mor

GP

SO

(33

0)

SO

(31

8)

SO

21

7(2

12

)

SO

12

37

25

52

IV-b

olus

toG

P8

74

SO

a(1

98

)Oslash

b(1

80

)Oslash

SO

22

7S

O1

32

SO

25

8pound

SO

(25

8)

SO

a1

51

b2

61

SO

32

4(3

30

)S

O3

21

Doo

r(1

30

)S

O2

44

SO

(22

6)

GP

-to-

max

TIM

IT

ICI

54

(48

)

SO

-to-

max

TIM

IT

ICI

a(3

78

)b(

34

2)

(22

0)

37

7(3

27

)

Abb

revi

atio

nsE

MS

E

mer

genc

yM

anag

emen

tof

Str

oke

ER

T

endo

vasc

ular

reva

scul

ariz

atio

ntr

eatm

ent

GP

gr

oin

punc

ture

IA

in

tra-

arte

rial

IA

T

intr

a-ar

teri

alth

erap

y(in

clud

esth

rom

boly

sis

and

mec

hani

cal

tech

niqu

es)

IMS

In

terv

enti

onal

Man

agem

ento

fStr

oke

tria

lM

ELT

M

iddl

ece

rebr

alar

tery

Em

bolis

mLo

calF

ibri

noly

tic

inte

rven

tion

Tria

lM

ER

CI

Mec

hani

calE

mbo

lus

Rem

oval

inC

ereb

ralI

sche

mia

PR

OA

CT

P

roly

sein

Acu

teC

ereb

ralT

hrom

boem

bolis

mtr

ial

PS

T

Piv

otal

Str

oke

Tria

lR

EC

AN

ALI

SE

R

Eca

nalis

atio

nus

ing

Com

bine

din

trav

enou

sA

ltep

lase

and

Neu

roin

terv

enti

onal

Alg

orit

hmfo

racu

teIs

chem

icS

trok

ER

S

retr

ieva

ble

sten

trt

PA

re

com

bina

ntti

ssue

plas

min

ogen

acti

vato

rS

O

sym

ptom

onse

tTI

CI

thro

mbo

lysi

sin

cere

bral

infa

rcti

onT

IMI

thro

mbo

lysi

sin

myo

card

iali

nfar

ctio

nU

K

urok

inas

e


times The Brain Attack Coalition has recommendedthat IV rtPA be administered within 60 minutesfrom arrival to the emergency department (ED) foreligible patients48 The established time intervals tar-get a multidisciplinary goal Each component of theprocessmdashED physicians ancillary staff laboratoryand radiology services neurology team and radiol-ogy staffmdashis essential for the time goal As suchERT time intervals should integrate into the existingmodel beginning with patient arrival to the EDSeparate time intervals can be established for patientstransferred from another institution and patientswho receive adjunctive ERT following IV rtPA ther-apy Because vascular anatomy can add unpredictabledelays in procedural times the endpoint should re-flect the last modifiable variable Therefore ERTtime intervals should reflect door-to-puncture (morepredictable) puncture-to-clot and clot-to-closegoals A clot-to-close time of 120 minutes as de-scribed in IMS III may be warranted to establishprocedural termination times More variables in-cluding anatomy evidence of persistent penumbraand ERT method may be used in the future to mod-ify time benchmarks

In the limited case series discussing time intervalsto ERT there is variability in which interval is uti-lized (table 4)56111215414349 ndash56 Randomized trialsshow feasibility in achieving time intervals of approx-imately 4 to 5 hours from stroke onset to IA rtPAadministration655 In PROACT II median timefrom stroke onset to randomization and IA rtPA ad-ministration was 282 minutes whereas the IMSstudy demonstrated an interval of 231 minutes fromstroke onset to IA rtPA administration655 Timefrom CT scan to microcatheter placement in thecerebrovasculature had a mean time of 174 60minutes in 91 patients undergoing ERT for AISdemonstrating wide variability and a need for timestandards53 Transferred patients whose laboratorytests and CT scan have already been completed maystill have a door-to-puncture time of up to 60 min-utes57 Further study is needed to identify barriers torapid access to endovascular therapy

Currently the American College of Cardiologyand the AHA recommend that door-to-balloon timein ST segment elevation myocardial infarctionshould be within 90 minutes A similar future pro-posal could be made for ERT in AIS with a goaldoor-to-puncture time of 90 minutes (table 5) Thiswould include activation of the stroke team technol-ogists and nurses Adjunctive time benchmarks canbe developed including puncture-to-clot and clot-to-close goals This target is more difficult to achievefor cerebral than cardiac revascularization as strokepatients require more time-consuming neurologic

Tab

le5

Ben

chm

ark

tim

esfo

rre

vasc

ular

izat

ion

ther

apie

san

dp

ossi

ble

inte

rval

sfo

rE

RT

Am

eric

anC

olle

geof

Car

diol

ogy6

7A

SA

AH

AA

ISG

uide

lines

forI

Vrt

-PA

68

Pro

pose

dgo

als

forA

ISpa

tien

tsel

igib

lefo

rE

RT

pres

enti

ngto

ED

ldquoP

rim

ary

ER

TTi

merdquo

Pro

pose

dgo

als

forA

ISpa

tien

tsel

igib

lefo

rRes

cue

ER

Tfo

llow

ing

IVfa

ilure

ldquoIV

-Fai

lure

toR

escu

eE

RTrdquo

Pro

pose

dgo

als

forA

ISpa

tien

tstr

ansf

erre

dfr

omou

tsid

eho

spit

alfo

rER

TldquoD

rip-

and-

Shi

pto

ER

Trdquo

Doo

r-to

-bal

loon

tim

e9

0m

inD

oor-

to-n

eedl

eti

me

60

min

Doo

r-to

-gro

inpu

nctu

reti

me

90

min

Nee

dle

-to-

gro

inp

unct

ure

tim

e6

0m

inD

oora -t

o-G

roin

Pun

ctur

eti

me

60

min

ST

EM

Icon

firm

ed

card

iolo

gis

tno

tifi

ed

10

min

Doo

rto

ED

10

min

Doo

rto

ED

Inpa

ralle

lwit

hIV

rtP

Apa

thw

ay(1

0m

in)

ER

Tte

amis

noti

fied

asso

onas

larg

eto

med

ium

vess

eloc

clus

ion

issu

spec

ted

(ie

N

IHS

Sh

yper

dens

eM

CA

onC

T)in

elig

ible

pati

ents

10

min

afte

rth

eel

igib

ility

CT

scan

and

befo

reIV

bolu

s

Tran

sfer

from

outs

ide

hosp

ital

init

iate

dan

gio

suit

eac

tiva

ted

team

acti

vate

d

Pri

orto

arri

val

ED

stab

ilize

sp

atie

nta

ctiv

ates

cath

lab

30

min

Str

oke

team

acti

vati

on1

5m

inS

trok

ean

dE

RT

team

sac

tiva

tion

Inpa

ralle

lwit

hIV

rtP

Apa

thw

ay(1

5m

in)

Rec

eivi

ngho

spit

alar

riva

lR

apid

hist

ory

and

exam

rev

iew

ofre

ferr

ing

hosp

ital

film

s

15

min

Cat

hla

ban

din

terv

enti

onal

ist

read

y

60

min

CT

scan

init

iate

d2

5m

inC

Tsc

anin

itia

ted

Inpa

ralle

lwit

hIV

rtP

Apa

thw

ay(2

5m

in)

Ang

iosu

ite

acti

vate

dte

amon

stan

dby

cons

ider

noni

nvas

ive

vasc

ular

imag

ing

25

min

afte

rth

eel

igib

ility

CT

scan

and

afte

rIV

bolu

sin

itia

tion

Anc

illar

ybr

ain

imag

ing

(ie

CT

perf

usio

n)3

5m

in

Fin

alch

eck

and

wri

tten

cons

ent

70

min

CT

scan

inte

rpre

ted

elig

ibili

tyas

sess

ed4

5m

inC

Tsc

anin

terp

rete

del

igib

ility

asse

ssed

Inpa

ralle

lwit

hIV

rtP

Apa

thw

ay(4

5m

in)

Rep

eat

NIH

SS

obt

ain

wri

tten

cons

ent

repe

atC

Tif

clin

ical

wor

seni

ng

45

min

afte

rth

eC

Tsc

anan

d3

0m

inaf

ter

the

IVrt

PA

bolu

s

Fin

alch

eck

wri

tten

cons

ent

pati

ent

prep

ped

45

min

Cat

hete

riza

tion

and

PC

Indashb

allo

onin

flat

ion

90

min

IVrt

PA

infu

sion

60

min

Gro

inpu

nctu

re9

0m

inG

roin

punc

ture

60

min

bG

roin

punc

ture

60

min

Abb

revi

atio

nsA

HA

A

mer

ican

Hea

rtA

ssoc

iati

onA

IS

acut

eis

chem

icst

roke

ang

io

angi

ogra

mA

SA

A

mer

ican

Str

oke

Ass

ocia

tion

ED

em

erge

ncy

depa

rtm

ent

ER

T

endo

vasc

ular

reva

scul

ariz

atio

nth

erap

yIA

intr

a-ar

teri

alM

CA

m

iddl

ece

rebr

alar

tery

NIH

SS

N

IHS

trok

eS

cale

PC

Ipe

rcut

aneo

usco

rona

ryin

terv

enti

onr

tPA

re

com

bina

ntti

ssue

plas

min

ogen

acti

vato

rS

TEM

IS

Tse

gmen

tele

vati

onm

yoca

rdia

linf

arct

ion

aF

rom

tim

eof

arri

valt

oac

cept

ing

hosp

ital

door

b

Tim

ew

illne

edto

bead

just

edto

allo

wfo

rad

diti

onal

imag

ing

ifcl

inic

alex

amin

atio

nw

orse

nsor

sym

ptom

ssu

gges

the

mor

rhag

ictr

ansf

orm

atio

n


evaluation and brain imaging before proceeding tothe angiography laboratory

Achieving a 90-minute door-to-puncture timewould likely require the neurointerventionalist toplay an integral part in the stroke team because thedecisions on treatment strategy may evolve as the pa-tient proceeds through the AIS protocol and IV rtPAevaluation pathway The ERT protocol should inte-grate into the IV rtPA pathway For interhospitaltransfers the completed imaging and laboratorystudies as well as additional lead time may reduce thetarget time interval to 60 minutes for door-to-puncture However significant delay in hospitaltransfer may warrant repeat neuroimaging when thepatient arrives at the recipient institution Bench-mark times will need to be established for IV nonre-sponders with special consideration for additionaldelay when clinical deterioration following IV rtPArequires a repeat brain imaging prior to ERT

Triage and transfer strategies The considerable de-cline in efficacy of revascularization therapies ataround 6 to 8 hours from symptom onset demandswell-organized triage and transfer strategies46 Emer-gency department reorganization has been an area offocus to improve early identification of stroke pa-tients Tracking door-to-thrombolysis times posi-tioning a CTMRI scanner within the departmentand having emergency medical services (EMS) send aprehospital notification are steps that have improvedthrombolysis access58 However given the limitedavailability of Comprehensive Stroke Center infra-structure few centers in a given geographic regionwill have capabilities for providing comprehensivestroke care and 247 ERT This will lead to a highproportion of patients eligible for ERT arriving byinterhospital transfer Transfer delay has been shownto be a major factor limiting the use of ERT in strokepatients accounting for an estimated odds of treat-ment decrease by 25 for every minute of transfertime59 To avoid transfer delay regional protocols fortriage of AIS patients by EMS personnel to desig-nated stroke centers has become a focus of prehospi-tal stroke triage policy60

Alternative strategies include initiation of IVthrombolytic in a referring hospital prior to transferldquodrip-and-shiprdquo followed by further management atthe accepting hospital which may include ERT Adescribed model of ldquodrip ship and retrieverdquo usedfull-dose IV rtPA (09 mgkg) followed by ERT withmechanical thrombectomy and thrombo-aspirationsuggesting feasibility in basilar artery occlusion61

Different models may evolve where the patient re-ceives ERT in an outside hospital and is transferredfor further care at a comprehensive stroke centerwhere neurosurgery neurocritical care and vascular

neurology expertise are available known as ldquoretrieve-and-shiprdquo Pay-for-performance measures similar tothose for acute myocardial infarction could help fa-cilitate transfer of appropriate patients from primaryto comprehensive stroke centers (the hub-and-spokemodel)

GENERAL PREPROCEDURAL AND INTRAPROCE-DURAL MANAGEMENT Anesthesia and monitoringThe type of anesthesia for ERT has been a topic ofcontroversy with recent reports suggesting worseoutcome with use of general endotracheal anesthesiapossibly due to treatment delays and complicationsfrom intubation6263 Alternatively conscious seda-tion may pose a different set of risks related to patientcooperation especially in those with severe aphasiaor neglect which may negatively influence time torevascularization and procedural success Further-more ancillary monitoring requiring invasive arterialaccess for blood pressure monitoring and central IVaccess may also be of limited value and add delay toinitiation of therapy Further study is needed to eval-uate sedation methods for ERT Sedation methodsmay currently vary among centers

Thromboprophylaxis with systemic anticoagulationArterial catheterization carries a risk of thromboem-bolism often requiring systemic anticoagulationRandomized clinical trials of ERT report variableprotocols for thromboprophylaxis including bolusIV heparin infusion of 2000 to 5000 units atprocedure onset followed by continuous infusionsof approximately 500 units of IV heparin per hourfor the procedure duration621 Alternatively acti-vated clotting time (ACT) values can be obtainedwith heparin boluses to maintain an ACT at atherapeutic goal Limited data exist on the safetyof heparin anticoagulation during ERT proce-dures A subgroup analysis of the MERCI trialshowed no association with hemorrhage or 90-daymortality and heparin use64 A reasonable ACTrange may be 250 to 300 seconds during ERT

Renal prophylaxis Patients with AIS may also havechronic renal impairment which may worsen withcontrast administered during angiography Inter-ventions designed to prevent contrast-induced ne-phropathy have not been rigorously studiedReasonable prophylaxis strategies include hydra-tion with isotonic saline Recent data have notprovided strong support for the administration ofN-acetylcysteine65 The use of sodium bicarbonateinfusion may be reasonable for patients with renalinsufficiency but it can be limited by the largevolume and time to acquire the solution from thepharmacy Periprocedural renal prophylaxis for


ERT in select AIS patients is an important area inneed of further investigation

POSTPROCEDURAL MANAGEMENT ImagingPatients may benefit from postprocedural imagingincluding noncontrast head CT or susceptibility-weighted MRI within 16 to 32 hours from ERTGiven the associated risk of hemorrhagic complica-tions with revascularization therapy urgent head CTor MRI may be needed for clinical deterioration inthe postprocedure period Intraprocedure imaging isalso possible in many angiography suites and can of-fer rapid diagnostic information

Neuromonitoring Intensive care unit monitoringwith staff trained in neurologic patient care may beimportant for postprocedure neuromonitoring in-cluding frequent neurologic examination assessmentsby nursing staff experienced and trained in neurovas-cular diseases Intensive monitoring would also in-clude surveillance for groin-access complications andthe appropriate management Stroke severity andoutcome scales may be important in performancemonitoring

Blood pressure management Patients in whom revas-cularization was successful may be at risk of reperfu-sion hemorrhage thereby warranting aggressiveblood pressure control Common practice has fol-lowed a protocol similar to that for post IV rtPAadministration with vigilant blood pressure monitor-ing for at least the first 24 hours Blood pressure ismeasured every 15 minutes for 2 hours then every30 minutes for 6 hours and every hour for 18hours Goal blood pressure is targeted to remainbelow 180105 mm Hg Bolus dosing of labetololor continuous infusion of nicardipine has beenused to achieve target blood pressure Adjustmentsin blood pressure parameters may be necessary toachieve clinical stability

Antithrombotic regimen Postprocedure antithrom-botic regimen will likely follow a similar pathway tothat in general AIS management Antithromboticsare usually avoided in the first 24 hours following IVand IA administration of a thrombolytic agent Cer-tain procedures may present exceptions such as pa-tients receiving stent implantation in which therespective preferred regimen will need to be imple-mented This may include loading doses of 325 to650 mg of aspirin (orally or rectally) and 300 to 600mg of clopidogrel with subsequent dual antiplatelettherapy with daily aspirin (325 mg) and clopidogrel(75 mg) for 4 to 12 weeks followed by indefinitesingle-antiplatelet therapy with aspirin 325 mg dailyor tailored to the underlying etiology A potentialhazard of dual antiplatelet therapy for acute stent im-

plantation in a patient with a recent large stroke in-cludes hemorrhage

Glycemia management Hyperglycemia may be asso-ciated with an increased risk of hemorrhagic transfor-mation of the cerebral infarction66 An appropriateglycemic-control regimen will likely be modeled afterexisting management strategies developed for AIS

Statin therapy Comprehensive management strate-gies for patients with AIS who undergo ERT willlikely also adopt statin therapy regimens modeled af-ter those developed for AIS patients in general

CLINICAL OUTCOME MEASUREMENTS Moni-toring clinical outcomes following ERT is importantfor quality metrics Thresholds and benchmarks foracceptable stroke severityndashweighted sICH and mor-tality rates need to be established The proportion ofpatients completing 90-day clinical follow-up (fromthose who are eligible) needs to be established Simi-larly consensus on rates of 90-day good functionalmRS outcome (score of 0ndash2) following ERT needsto be established

DISCUSSION This outline can be used as a frame-work for the development of future practice recom-mendations and as an interim tool that the practicingneurovascular specialist can use to assess the rapidlyevolving management strategies This evolving fieldis marked by ongoing intense investigation of varioustherapies for acute revascularization which will de-mand frequent reevaluation and modification ofthese strategies

AUTHOR CONTRIBUTIONSAll authors participated in the design and revision of the manuscript Dr

Lazzaro draftingrevising the manuscript study concept or design analy-

sis or interpretation of data Dr Novakovic draftingrevising the manu-

script acquisition of data statistical analysis study supervision Dr

Alexandrov draftingrevising the manuscript discussion of review con-

tent Dr Darkhabani draftingrevising the manuscript acquisition of

data Dr Edgell draftingrevising the manuscript Dr English drafting

revising the manuscript analysis or interpretation of data Dr Frei draft-

ingrevising the manuscript Dr Jamieson draftingrevising the

manuscript Dr Janardhan draftingrevising the manuscript study con-

cept or design analysis or interpretation of data development of stroke

algorithms and figures for acute ischemic stroke endovascular therapy Dr

N Janjua draftingrevising the manuscript Dr RM Janjua drafting

revising the manuscript Dr Katzan draftingrevising the manuscript Dr

Khatri study concept or design Dr Kirmani study concept or design

study supervision Dr Liebeskind draftingrevising the manuscript anal-

ysis or interpretation of data acquisition of data Dr Linfante drafting

revising the manuscript study concept or design analysis or

interpretation of data study supervision Dr Nguyen draftingrevising

the manuscript Dr Saver draftingrevising the manuscript study con-

cept or design analysis or interpretation of data Dr Shutter drafting

revising the manuscript Dr Xavier draftingrevising the manuscript Dr

Yavagal draftingrevising the manuscript Dr Zaidat draftingrevising

the manuscript study concept or design contribution of vital reagents

toolspatients acquisition of data statistical analysis study supervision


DISCLOSUREDr Lazzaro reports no disclosures Dr Novakovic performs endovascular

treatments for acute ischemic strokes (has not used a retrievable stent) Dr

Alexandrov serves as an Associate Editor for Frontiers in Interventional

Neurology has a patent for Therapeutic Methods and Apparatus for Use of

Sonication to Enhance Perfusion of Tissue has received publishing royalties

for Cerebrovascular Ultrasound in Stroke Prevention and Treatment (first

and second editions) has served as a consultant for Cerevast Therapeutics

spends 60 effort on clinical stroke service at Comprehensive Stroke

Center UAB Hospital monitoring endovascular procedures and evaluat-

ing success of recanalization with imaging has received research support

from Cerevast Therapeutics Inc has received research support from

NINDS has received compensation from Cerevast Therapeutics Inc

and has received license fee payments from Therapeutic Methods and Ap-

paratus for Use of Sonication to Enhance Perfusion of Tissue Dr Darkha-

bani reports no disclosures Dr Edgell serves as an Associate Editor

Frontiers in Interventional Neurology Dr English has served on the scien-

tific advisory board of Concentric Medical Inc Clinical Events Commit-

tee serves on the editorial boards of Neurohospitalist and The Stroke

Interventionalist and serves as Medical Scientific Advisor for Silk Road

Medical Dr Frei has served as a consultant to Penumbra Inc Dr Ja-

mieson has served as a consultant to Bayer and Boerhinger-Ingelheim

served on the speakers bureau for Boehringer-Ingelheim and Merck

served on the scientific advisory board for Bayer and on the Adjudication

Committee for ARRIVE trial and serves as an Assistant Editor for Neurol-

ogy Alert Dr Janardhan reports no disclosures Dr N Janjua serves on

the scientific advisory board for LundbeckDSMB and Neurointerven-

tions receives research support from NIHNINDS and holds stock or

stock options or board of directors compensation for Neurointerventions

Dr RM Janjua reports no disclosures Dr Katzan has served as consul-

tant to Pzifer and Genentech served as a speaker for and received com-

pensation from Cardionet serves on the Real World Advisory Board for

Pfizer has received research funding from Novartis Inc Hoffman-La

Roche Ltd and Takeda Pharmaceuticals and has received research fund-

ing from Ohio Department of Health Dr Khatri is on the Executive

Committee of the IMS III Trial is Neurology PI of the Penumbra

THERAPY Trial and has received research support from Genentech

Inc for survey implementation served on the editorial boards of Frontiers

in Endovascular and Interventional Neurology has received research sup-

port from the NIHNINDS and has served as an expert witness for stroke

cases over the last 2 years Dr Kirmani served on the advisory board for

Otsuka Pharmaceuticals served as an Associate Editor for Frontiers in

Clinical Trials in Neurology received publishing royalties from the Taylor

and Francis Group for The Stroke Center Handbook receives research sup-

port from Penumbra Inc and Genentech Inc received research support

from NIHNINDS and has served as expert witness for stroke cases Dr

Liebeskind served as a consultant for Concentric Medical and CoAxia and

receives research support from NIH Dr Linfante served as a consultant

for Codman Neurovascular and Stryker holds stock options in Surpass

Limited serves on the Scientific Advisory Board for Codman Neurovas-

cular serves on the editorial boards for Stroke and Journal of Neurointer-

ventional Surgery and serves on the speakers bureau for Codman Dr

Nguyen serves as Associate Editor of Frontiers in Vascular and Interven-

tional Neurology and Editor of SVIN newsletter The Core performs intra-

arterial stroke procedures and serves as a consultant for Penumbra Dr

Saver serves on the editorial boards of Stroke Reviews in Neurologic Dis-

ease Journal of Neuroimaging and Journal of Stroke and Cerebrovascular

Diseases is an employee of the University of California (UC) which holds

a patent on retriever devices for stroke serves on scientific advisory

boards for which the UC Regents receive payments for CoAxia Inc

Concentric Medical Talecris Biotherapeutics Ferrer AGA Medical Cor-

poration BrainsGate PhotoThera Ev3 and Sygnis Bioscience GmbH amp

Co KG is an unpaid site investigator in multicenter clinical trials spon-

sored by AGA Medical Corporation Lundbeck Inc and Ev3 for which

the UC Regents received payments based on clinical trial contracts for the

number of subjects enrolled is an unpaid site investigator in the NIH

IRIS CLEAR IMS 3 SAMMPRIS and VERITAS multicenter clinical

trials for which the UC Regents receive payments based on clinical trial

contracts for the number of subjects enrolled receives research support

from the NIH and NINDS receives research support from the AHA and

performs acute stroke care (35) Dr Shutter serves on the scientific

advisory board for Neuren Pharmaceuticals receives funding for travel or

speaker honoraria from Codman JampJ and NIH serves as a consultant for

Cincinnati Bengals receives research support from Department of De-

fense and NIH (NINDS) receives research support from the Mayfield

Education and Research Fund and holds stock options in UCB Pharma

Dr Xavier receives research support from Concentric Medical and from

Medical University of South CarolinaNIH study Dr Yavagal received

an honorarium from Penumbra Inc for consultation and speaking serves

as an Associate Editor for Frontiers in Endovascular Neurology and serves

as a consultant to Penumbra Inc Codman Neurovascular Micrus Inc

Genentech and Boston Scientific Dr Zaidat serves on the scientific advi-

sory board for Talecris served on the adjudication committee for Stryker

received speaker honoraria from Stryker served on the editorial board of

Frontiers in Neurology (Endovascular amp Interventional Neurology Sec-

tion) serves as Editor of The Journal of Neurointerventional Surgery and

serves as Associate Editor and is a member of the Editorial Board of Jour-

nal of Stroke amp Cerebrovascular Diseases served as a consultant for Stryker

Neurovascular Codman Neurovascular and Microvention Inc and has

received research support from Society of Vascular amp Interventional Neu-

rology (SVIN) for this educational activity Go to Neurologyorg for full

disclosures

Received December 10 2011 Accepted in final form February 23 2012

REFERENCES1 Adams HP Jr del Zoppo G Alberts MJ et al Guidelines

for the early management of adults with ischemic stroke aguideline from the American Heart AssociationAmericanStroke Association Stroke Council Clinical CardiologyCouncil Cardiovascular Radiology and InterventionCouncil and the Atherosclerotic Peripheral Vascular Dis-ease and Quality of Care Outcomes in Research Interdisci-plinary Working Groups Stroke 2007381655ndash1711

2 The National Institute of Neurological Disorders andStroke rt-PA Stroke Study Group Tissue plasminogen ac-tivator for acute ischemic stroke N Engl J Med 19953331581ndash1587

3 Zaidat OO Suarez JI Sunshine JL et al Thrombolytictherapy of acute ischemic stroke correlation of angio-graphic recanalization with clinical outcome AJNR Am JNeuroradiol 200526880ndash884

4 Rha JH Saver JL The impact of recanalization on ischemicstroke outcome a meta-analysis Stroke 200738967ndash973

5 del Zoppo GJ Higashida RT Furlan AJ Pessin MS Row-ley HA Gent M PROACT a phase II randomized trial ofrecombinant pro-urokinase by direct arterial delivery inacute middle cerebral artery stroke PROACT Investiga-tors Prolyse in Acute Cerebral Thromboembolism Stroke1998294ndash11

6 Furlan A Higashida R Wechsler L et al Intra-arterialprourokinase for acute ischemic stroke the PROACT IIstudy a randomized controlled trial Prolyse in Acute Ce-rebral Thromboembolism JAMA 19992822003ndash2011

7 Alberts MJ Latchaw RE Selman WR et al Recommenda-tions for comprehensive stroke centers a consensus statementfrom the Brain Attack Coalition Stroke 2005361597ndash1616

8 Leifer D Bravata DM Connors JJ 3rd et al Metrics formeasuring quality of care in comprehensive stroke centersdetailed follow-up to Brain Attack Coalition comprehensivestroke center recommendations a statement for healthcareprofessionals from the American Heart AssociationAmericanStroke Association Stroke 201142849ndash877

9 Meyers PM Schumacher HC Higashida RT et al Indica-tions for the performance of intracranial endovascular neu-


rointerventional procedures a scientific statement from

the American Heart Association Council on Cardiovascu-

lar Radiology and Intervention Stroke Council Council

on Cardiovascular Surgery and Anesthesia Interdisciplin-

ary Council on Peripheral Vascular Disease and Interdisci-

plinary Council on Quality of Care and Outcomes

Research Circulation 20091192235ndash2249

10 Smith WS Sung G Starkman S et al Safety and efficacy

of mechanical embolectomy in acute ischemic stroke re-

sults of the MERCI trial Stroke 2005361432ndash1438

11 The penumbra pivotal stroke trial safety and effectiveness

of a new generation of mechanical devices for clot removal

in intracranial large vessel occlusive disease Stroke 2009

402761ndash2768

12 Ogawa A Mori E Minematsu K et al Randomized trial

of intraarterial infusion of urokinase within 6 hours of

middle cerebral artery stroke the Middle Cerebral Artery

Embolism Local Fibrinolytic Intervention Trial (MELT)

Japan Stroke 2007382633ndash2639

13 Lee M Hong KS Saver JL Efficacy of intra-arterial fibri-

nolysis for acute ischemic stroke meta-analysis of random-

ized controlled trials Stroke 201041932ndash937

14 Inoue T Kimura K Minematsu K Yamaguchi T A case-

control analysis of intra-arterial urokinase thrombolysis in

acute cardioembolic stroke Cerebrovasc Dis 200519225ndash

228

15 Nogueira RG Liebeskind DS Sung G Duckwiler G Smith

WS Predictors of good clinical outcomes mortality and suc-

cessful revascularization in patients with acute ischemic stroke

undergoing thrombectomy pooled analysis of the Mechani-

cal Embolus Removal in Cerebral Ischemia (MERCI) and

Multi MERCI Trials Stroke 2009403777ndash3783

16 Saver JL Liebeskind DS Nogueira RG Jahan R Need to

clarify Thrombolysis In Myocardial Ischemia (TIMI) scale

scoring method in the Penumbra Pivotal Stroke Trial

Stroke 201041e115ndashe116

17 Intra-arterial Versus Systemic Thrombolysis for Acute

Ischemic Stroke SYNTHESIS EXP Available at stroke-

centerorg Accessed November 26 2011

18 MR CLEAN a multicenter randomized clinical trial of endo-

vascular treatment for acute ischemic stroke in the Nether-

lands 2011 Available at wwwtrialregisternltrialregadmin

rctviewaspTC1804 Accessed November 26 2011

19 Mechanical Retrieval and Recanalization of Stroke Clots

Using Embolectomy MR RESCUE Available at clinical-

trialsgovct2showNCT00389467 Accessed November

26 2011

20 Assess the Penumbra System in the Treatment of Acute

Stroke (THERAPY) Available at clinicaltrialsgovct2

showNCT01429350 Accessed November 26 2011

21 The Interventional Management of Stroke (IMS) trials

Available at httpwwwstrokecenterorgtrialstrialDe-

tailaspxtid747 Accessed August 26 2011

22 Zaidat OO Wolfe T Hussain SI et al Interventional

acute ischemic stroke therapy with intracranial self-

expanding stent Stroke 2008392392ndash2395

23 Roth C Papanagiotou P Behnke S et al Stent-assisted

mechanical recanalization for treatment of acute intracere-

bral artery occlusions Stroke 2010412559ndash2567

24 Castano C Dorado L Guerrero C et al Mechanical

thrombectomy with the Solitaire AB device in large artery

occlusions of the anterior circulation a pilot study Stroke

2010411836ndash1840

25 Hacke W Kaste M Bluhmki E et al Thrombolysis withalteplase 3 to 45 hours after acute ischemic stroke N EnglJ Med 20083591317ndash1329

26 Clark WM Wissman S Albers GW Jhamandas JH Mad-den KP Hamilton S Recombinant tissue-type plasmino-gen activator (alteplase) for ischemic stroke 3 to 5 hoursafter symptom onset the ATLANTIS study a randomizedcontrolled trial Alteplase Thrombolysis for Acute Nonin-terventional Therapy in Ischemic Stroke JAMA 19992822019ndash2026

27 Del Zoppo GJ Saver JL Jauch EC Adams HP Jr Expan-sion of the time window for treatment of acute ischemicstroke with intravenous tissue plasminogen activator a sci-ence advisory from the American Heart AssociationAmer-ican Stroke Association Stroke 2009402945ndash2948

28 Eckert B Kucinski T Pfeiffer G Groden C Zeumer HEndovascular therapy of acute vertebrobasilar occlusionearly treatment onset as the most important factor Cere-brovasc Dis 20021442ndash50

29 Smith WS Sung G Saver J et al Mechanical thrombec-tomy for acute ischemic stroke final results of the MultiMERCI trial Stroke 2008391205ndash1212

30 Schulte-Altedorneburg G Hamann GF Mull M et alOutcome of acute vertebrobasilar occlusions treated withintra-arterial fibrinolysis in 180 patients AJNR Am J Neu-roradiol 2006272042ndash2047

31 Arnold M Nedeltchev K Schroth G et al Clinical andradiological predictors of recanalisation and outcome of 40patients with acute basilar artery occlusion treated withintra-arterial thrombolysis J Neurol Neurosurg Psychiatry200475857ndash862

32 Schonewille WJ Wijman CA Michel P et al Treatmentand outcomes of acute basilar artery occlusion in the Basi-lar Artery International Cooperation Study (BASICS) aprospective registry study Lancet Neurol 20098724 ndash730

33 Mishra NK Albers GW Davis SM et al Mismatch-baseddelayed thrombolysis a meta-analysis Stroke 201041e25ndashe33

34 Jovin TG Liebeskind DS Gupta R et al Imaging-basedendovascular therapy for acute ischemic stroke due toproximal intracranial anterior circulation occlusion treatedbeyond 8 hours from time last seen well retrospective mul-ticenter analysis of 237 consecutive patients Stroke 2011422206ndash2211

35 Hacke W Kaste M Fieschi C et al Intravenous throm-bolysis with recombinant tissue plasminogen activator foracute hemispheric stroke the European Cooperative AcuteStroke Study (ECASS) JAMA 19952741017ndash1125

36 Pexman JH Barber PA Hill MD et al Use of the AlbertaStroke Program Early CT Score (ASPECTS) for assessingCT scans in patients with acute stroke AJNR Am J Neu-roradiol 2001221534ndash1542

37 Saqqur M Uchino K Demchuk AM et al Site of arterialocclusion identified by transcranial Doppler predicts theresponse to intravenous thrombolysis for stroke Stroke200738948ndash954

38 Mathews MS Sharma J Snyder KV et al Safety effective-ness and practicality of endovascular therapy within thefirst 3 hours of acute ischemic stroke onset Neurosurgery200965860ndash865 2009

39 Gupta R Tayal AH Levy EI et al Intra-arterial throm-bolysis or stent placement during endovascular treatmentfor acute ischemic stroke leads to the highest recanalization


rate results of a multicenter retrospective study Neurosur-gery 2011681618ndash1623

40 The Interventional Management of Stroke (IMS) II studyStroke 2007382127ndash2135

41 Mazighi M Serfaty JM Labreuche J et al Comparison ofintravenous alteplase with a combined intravenous-endovascular approach in patients with stroke and con-firmed arterial occlusion (RECANALISE study) aprospective cohort study Lancet Neurol 20098802ndash809

42 Rubiera M Ribo M Pagola J et al Bridging intravenous-intra-arterial rescue strategy increases recanalization andthe likelihood of a good outcome in nonresponder intrave-nous tissue plasminogen activator-treated patients a case-control study Stroke 201142993ndash997

43 Costalat V Machi P Lobotesis K et al Rescue combinedand stand-alone thrombectomy in the management oflarge vessel occlusion stroke using the solitaire device aprospective 50-patient single-center study timing safetyand efficacy Stroke 2011421929ndash1935

44 Eckert B Koch C Thomalla G et al Aggressive therapywith intravenous abciximab and intra-arterial rtPA and ad-ditional PTAstenting improves clinical outcome in acutevertebrobasilar occlusion combined local fibrinolysis andintravenous abciximab in acute vertebrobasilar stroketreatment (FAST) results of a multicenter study Stroke2005361160ndash1165

45 Pfefferkorn T Mayer TE Opherk C et al Staged escala-tion therapy in acute basilar artery occlusion intravenousthrombolysis and on-demand consecutive endovascularmechanical thrombectomy preliminary experience in 16patients Stroke 2008391496ndash1500

46 Khatri P Abruzzo T Yeatts SD Nichols C Broderick JPTomsick TA Good clinical outcome after ischemic strokewith successful revascularization is time-dependent Neu-rology 2009731066ndash1072

47 Nogueira RG Smith WS Sung G et al Effect of time toreperfusion on clinical outcome of anterior circulation strokestreated with thrombectomy pooled analysis of the MERCIand Multi MERCI trials Stroke Epub 2011 Sept 15

48 NINDS Proceedings of a National Symposium on RapidIdentification and Treatment of Acute Stroke NationalInstitute of Neurological Disorders and Stroke 2011Available at httpwwwnindsnihgovnews_and_eventsproceedingsstroke_proceedingsexecsumhtm AccessedSeptember 15 2011

49 Mattle HP Arnold M Georgiadis D et al Comparison ofintraarterial and intravenous thrombolysis for ischemicstroke with hyperdense middle cerebral artery sign Stroke200839379ndash383

50 Wolfe T Suarez JI Tarr RW et al Comparison of com-bined venous and arterial thrombolysis with primary arte-rial therapy using recombinant tissue plasminogenactivator in acute ischemic stroke J Stroke CerebrovascDis 200817121ndash128

51 Suarez JI Sunshine JL Tarr R et al Predictors of clinicalimprovement angiographic recanalization and intracra-nial hemorrhage after intra-arterial thrombolysis for acuteischemic stroke Stroke 1999302094ndash2100

52 Flaherty ML Woo D Kissela B et al Combined IV andintra-arterial thrombolysis for acute ischemic stroke Neu-rology 200564386ndash388

53 Miley JT Memon MZ Hussein HM et al A multicenteranalysis of ldquotime to microcatheterrdquo for endovascular therapyin acute ischemic stroke J Neuroimaging 201121159ndash64

54 Ducrocq X Bracard S Taillandier L et al Comparison of

intravenous and intra-arterial urokinase thrombolysis for

acute ischaemic stroke J Neuroradiol 20053226ndash32

55 Combined intravenous and intra-arterial recanalization for

acute ischemic stroke the Interventional Management of

Stroke Study Stroke 200435904ndash911

56 Lewandowski CA Frankel M Tomsick TA et al Com-

bined intravenous and intra-arterial r-TPA versus intra-

arterial therapy of acute ischemic stroke Emergency

Management of Stroke (EMS) Bridging Trial Stroke

1999302598ndash2605

57 Lazzaro MA LV Mohammad Y Chen M Lopes DK

Prabhakaran S Weekend effect is not observed in time to

angiography for transferred acute ischemic stroke patients

Cerebrovasc Diseases 201029(suppl 2)329

58 Lindsberg PJ Happola O Kallela M Valanne L Kuisma

M Kaste M Door to thrombolysis ER reorganization and

reduced delays to acute stroke treatment Neurology 2006

67334ndash336

59 Prabhakaran S Ward E John S et al Transfer delay is a

major factor limiting the use of intra-arterial treatment in

acute ischemic stroke Stroke 2011421626ndash1630

60 Crocco TJ Grotta JC Jauch EC et al EMS management

of acute strokendashprehospital triage (resource document to

NAEMSP position statement) Prehosp Emerg Care 2007

11313ndash317

61 Pfefferkorn T Holtmannspotter M Schmidt C et al

Drip ship and retrieve cooperative recanalization therapy

in acute basilar artery occlusion Stroke 201041722ndash726

62 Abou-Chebl A Lin R Hussain MS et al Conscious seda-

tion versus general anesthesia during endovascular therapy

for acute anterior circulation stroke preliminary results

from a retrospective multicenter study Stroke 201041

1175ndash1179

63 Gupta R Local is better than general anesthesia during

endovascular acute stroke interventions Stroke 201041

2718ndash2719

64 Nahab F Walker GA Dion JE Smith WS Safety of

periprocedural heparin in acute ischemic stroke endovas-

cular therapy the Multi MERCI trial J Stroke Cerebro-

vasc Dis Epub 2011 June 1

65 Acetylcysteine for prevention of renal outcomes in patients

undergoing coronary and peripheral vascular angiography

main results from the randomized Acetylcysteine for

Contrast-Induced Nephropathy Trial (ACT) Circulation

20111241250ndash1259

66 Kase CS Furlan AJ Wechsler LR et al Cerebral hemor-

rhage after intra-arterial thrombolysis for ischemic stroke

the PROACT II trial Neurology 2001571603ndash1610

67 Antman EM Anbe DT Armstrong PW et al ACCAHA

guidelines for the management of patients with ST-

elevation myocardial infarction a report of the American

College of CardiologyAmerican Heart Association Task

Force on Practice Guidelines (Committee to Revise the

1999 Guidelines for the Management of Patients with

Acute Myocardial Infarction) J Am Coll Cardiol 200444

E1ndashE211

68 Fonarow GC Smith EE Saver JL et al Improving door-

to-needle times in acute ischemic stroke the design and

rationale for the American Heart AssociationAmerican

Stroke Associationrsquos target stroke initiative Stroke 2011

422983ndash2989


DOI 101212WNL0b013e31826959fc201279S243-S255 Neurology

Marc A Lazzaro Roberta L Novakovic Andrei V Alexandrov et al ischemic stroke

Developing practice recommendations for endovascular revascularization for acute

This information is current as of September 24 2012

ServicesUpdated Information amp

httpnneurologyorgcontent7913_Supplement_1S243fullincluding high resolution figures can be found at

References

1httpnneurologyorgcontent7913_Supplement_1S243fullref-list-This article cites 60 articles 41 of which you can access for free at

Citations

ticleshttpnneurologyorgcontent7913_Supplement_1S243fullotherarThis article has been cited by 1 HighWire-hosted articles

Subspecialty Collections

ehttpnneurologyorgcgicollectionall_cerebrovascular_disease_strokAll Cerebrovascular diseaseStrokefollowing collection(s) This article along with others on similar topics appears in the

Permissions amp Licensing

httpwwwneurologyorgaboutabout_the_journalpermissionsits entirety can be found online atInformation about reproducing this article in parts (figurestables) or in

Reprints

httpnneurologyorgsubscribersadvertiseInformation about ordering reprints can be found online

rights reserved Print ISSN 0028-3878 Online ISSN 1526-632X1951 it is now a weekly with 48 issues per year Copyright Copyright copy 2012 by AAN Enterprises Inc All

reg is the official journal of the American Academy of Neurology Published continuously sinceNeurology

extraction in the American Heart Association(AHA) guidelines1ndash9 Two device familieshave FDA approval for ERT the Merci Re-triever (Concentric Medical Inc MountainView CA) and the Penumbra Aspiration Sys-tem (Penumbra Inc Alameda CA) andmultiple new devices are rapidly approachingFDA approval and market availability1011 Es-tablished guidelines and recommendationsare available for the early treatment of adultswith AIS1 and for the development of com-prehensive stroke centers7 and training stan-dards for endovascular ischemic stroketreatment9 However guidelines for ERT forAIS are lacking Ongoing clinical trials andthe brisk pace of emerging technologies havefostered enthusiasm for endovascular therapyfor AIS resulting in the need for developmentof practice recommendations

This outline was developed by a panel ofphysicians with a range of expertise in neuro-interventional procedures vascular neurol-ogy neurocritical care neurosurgery andneuroradiology In many instances definitiveclinical trialndashbased data are lacking and prac-tices are discussed on the basis of pathophysi-ologic rationale and expert opinion not onthe basis of randomized clinical trials

SAFETY AND EFFICACY OF ENDOVASCULARREVASCULARIZATION THERAPY FOR ACUTEISCHEMIC STROKE Endovascular treatment op-tions for intracerebral revascularization have evolvedconsiderably over the past decade Several trials eval-uating the various therapies are summarized in table1 The Prolyse in Acute Cerebral Thromboembolism(PROACT) and PROACT II studies evaluated theuse of IA thrombolysis with prourokinase in middlecerebral artery (MCA) occlusions56 The initial phase2 trial demonstrated higher recanalization rates withprourokinase5 The phase 3 trial PROACT II dem-onstrated the effectiveness of IA thrombolysis withprourokinase in patients with an MCA occlusiontreated within 6 hours from symptom onset6 A min-imum requirement NIH Stroke Scale (NIHSS) scoreof 4 except for isolated aphasia or hemianopia wasrequired for enrollment Patients treated with prou-rokinase had a higher rate of recanalization (66 vs18 p 0001) and were more likely to have agood outcome (modified Rankin Scale [mRS] scoreof 0ndash2 at 90 days 40 vs 25 p 004) despite ahigher rate of symptomatic intracranial hemor-rhage (sICH) (10 vs 2 p 006) The MCA-

Embolism Local fibrinolytic intervention Trial(MELT) was a similarly designed trial comparingurokinase to placebo in patients with MCA occlu-sions which was terminated early because of the ap-proval of the IV administration of rtPA in Japan12

Although the MELT findings are underpowered theresults are consistent with those of the PROACT tri-als suggesting higher recanalization rates (74) withIA thrombolysis12 A meta-analysis of these 3 trialsand 2 additional smaller trials combined 395 ran-domized patients and showed that IA thrombolysisincreased the odds of both nondisabled outcome(mRS score 0ndash1 OR 25 95 CI 133ndash314 p

0001) and nondependent outcome (mRS score 0ndash2OR 14 95 CI 131ndash351 p 0003)13 A case-control analysis from Japanrsquos Multicenter Stroke In-vestigatorsrsquo Collaboration (J-MUSIC) compared 91patients with an acute cardioembolic stroke treatedwith IA urokinase within 45 hours of symptom on-set to a matched control group that did not receiveIA therapy The analysis showed that a favorable out-come (mRS score of 0 ndash2) was more frequentlyobserved in the urokinase group (505 vs 341p 00124) and there was no difference in mortal-ity rate14 Although confirmatory trials required forFDA approval of IA therapy have not been per-formed these randomized trials and numerous caseseries support the use of IA thrombolysis in selectpatients who are ineligible for IV thrombolysis

Mechanical devices for ERT have evolved as ameans of achieving faster rates of recanalization inmedium- to large-vessel occlusions The MechanicalEmbolus Removal in Cerebral Ischemia (MERCI)and Multi-MERCI were prospective single-armmulticenter trials designed to test the efficacy andsafety of a corkscrew thrombectomy device in thetreatment of medium- to large-vessel occlusions (an-terior and posterior circulation) within 8 hours ofsymptom onset10 A combined analysis of the 2 stud-ies demonstrated a successful recanalization rate (de-fined as Thrombolysis in Myocardial Infarction 2 or3 score) of 646 with good clinical outcome (mRSscore of 0ndash2) in 324 despite an sICH rate of78 in the first study and 98 in the second15

The Penumbra Pivotal Stroke Trial provided registrydata on a novel aspiration-thrombectomy device thePenumbra system used within 8 hours for large-artery cerebrovascular occlusion11 A quarter of thepatients achieved an mRS score of less than or equalto 2 at 90 days Different techniques for measuringrecanalization preclude a direct comparison betweenthe rates achieved with MERCI and Penumbra butboth exceed the natural history rate16

Randomized trials are ongoing such as the LocalVersus Systemic Thrombolysis for Acute Ischemic






Tab

le1

Dat

afr

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lect

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dov

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tion

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on)

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UK

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Ret

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Abb

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ryM

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bolis

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lyti

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terv

enti

onTr

ial

ME

RC

IM

echa

nica

lEm

bolu

sR

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alin

Cer

ebra

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hem

iam

RS

m

odif

ied

Ran

kin

Sca

leN

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S

NIH

Str

oke

Sca

leP

CA

po

ster

ior

cere

bral

arte

ryP

ICA

po

ster

ior

infe

rior

cere

bella

rar

tery

PR

OA

CT

P

roly

sein

Acu

teC

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ralT

hrom

boem

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ial

PS

T

Piv

otal

Str

oke

Tria

lR

CT

ra

ndom

ized

cont

rolle

dtr

ial

SC

A

supe

rior

cere

bella

rar

tery

SIC

H

sym

ptom

atic

intr

acra

nial

hem

orrh

age

TIC

Ith

rom

boly

sis

ince

rebr

alin

farc

tion

TIM

Ith

rom

boly

sis

inm

yoca

rdia

linf

arct

ion

tPA

ti

ssue

plas

min

ogen

acti

vato

rU

K

urok

inas

eV

A

intr

acra

nial

vert

ebra

lart

ery



































Imaging findings








History of ICH


Pregnancy



























Distal tothrombus






















urokinase







Tab

le4

Tre

atm

ent

tim

esin

sele

cted

stud

ies

inm

inut

es

Tri

alP

RO

AC

T5

PR

OA

CT

II6

IMS

I55IM

SII

I21E

MS

56M

ELT

12R

EC

AN

ALI

SE

41P

enum

bra

PS

T11

Mul

tiM

ER

CI29

M

ER

CI10

Wol

feet

al50

Doc

rocq

etal

54C

osta

lat

etal

43M

iley

etal

53S

uare

zet

al51

Mat

tle

etal

49F

lahe

rty

etal

52

No

ofsu

bje

cts

40

12

16

25

00

35

56

50

12

53

05

96

13

50

91

54

57

44

Tre

atm

ent

IApr

oUK

orpl

aceb

oIA

proU

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rtP

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aor

IV

IAb

IV-I

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IAU

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Trt

PA

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IV

rtP

AIA

TIV

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PA

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UK

IV-R

Sor

RS

alon

eIV

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Tor

IAT

IAU

KIA

TU

KIV

IA

rtP

A

Tim

e-to

-doo

r1

14

Tim

e-to

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MR

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anm

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(med

ian)

Ons

et1

05

Ons

et1

62

(14

5)

Doo

r5

9(3

4)

Imag

ing

-to-

GP

16

1(1

53

)8

1(6

5)

CT

scan

-to-

mic

roca

thet

er1

74

Tim

e-to

-ER

Tin

itia

tion

oran

gio

gra

mor

GP

SO

(33

0)

SO

(31

8)

SO

21

7(2

12

)

SO

12

37

25

52

IV-b

olus

toG

P8

74

SO

a(1

98

)Oslash

b(1

80

)Oslash

SO

22

7S

O1

32

SO

25

8pound

SO

(25

8)

SO

a1

51

b2

61

SO

32

4(3

30

)S

O3

21

Doo

r(1

30

)S

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44

SO

(22

6)

GP

-to-

max

TIM

IT

ICI

54

(48

)

SO

-to-

max

TIM

IT

ICI

a(3

78

)b(

34

2)

(22

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27

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Abb

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atio

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MS

E

mer

genc

yM

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Str

oke

ER

T

endo

vasc

ular

reva

scul

ariz

atio

ntr

eatm

ent

GP

gr

oin

punc

ture

IA

in

tra-

arte

rial

IA

T

intr

a-ar

teri

alth

erap

y(in

clud

esth

rom

boly

sis

and

mec

hani

cal

tech

niqu

es)

IMS

In

terv

enti

onal

Man

agem

ento

fStr

oke

tria

lM

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M

iddl

ece

rebr

alar

tery

Em

bolis

mLo

calF

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noly

tic

inte

rven

tion

Tria

lM

ER

CI

Mec

hani

calE

mbo

lus

Rem

oval

inC

ereb

ralI

sche

mia

PR

OA

CT

P

roly

sein

Acu

teC

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ralT

hrom

boem

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mtr

ial

PS

T

Piv

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Str

oke

Tria

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EC

AN

ALI

SE

R

Eca

nalis

atio

nus

ing

Com

bine

din

trav

enou

sA

ltep

lase

and

Neu

roin

terv

enti

onal

Alg

orit

hmfo

racu

teIs

chem

icS

trok

ER

S

retr

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ble

sten

trt

PA

re

com

bina

ntti

ssue

plas

min

ogen

acti

vato

rS

O

sym

ptom

onse

tTI

CI

thro

mbo

lysi

sin

cere

bral

infa

rcti

onT

IMI

thro

mbo

lysi

sin

myo

card

iali

nfar

ctio

nU

K

urok

inas

e





Tab

le5

Ben

chm

ark

tim

esfo

rre

vasc

ular

izat

ion

ther

apie

san

dp

ossi

ble

inte

rval

sfo

rE

RT

Am

eric

anC

olle

geof

Car

diol

ogy6

7A

SA

AH

AA

ISG

uide

lines

forI

Vrt

-PA

68

Pro

pose

dgo

als

forA

ISpa

tien

tsel

igib

lefo

rE

RT

pres

enti

ngto

ED

ldquoP

rim

ary

ER

TTi

merdquo

Pro

pose

dgo

als

forA

ISpa

tien

tsel

igib

lefo

rRes

cue

ER

Tfo

llow

ing

IVfa

ilure

ldquoIV

-Fai

lure

toR

escu

eE

RTrdquo

Pro

pose

dgo

als

forA

ISpa

tien

tstr

ansf

erre

dfr

omou

tsid

eho

spit

alfo

rER

TldquoD

rip-

and-

Shi

pto

ER

Trdquo

Doo

r-to

-bal

loon

tim

e9

0m

inD

oor-

to-n

eedl

eti

me

60

min

Doo

r-to

-gro

inpu

nctu

reti

me

90

min

Nee

dle

-to-

gro

inp

unct

ure

tim

e6

0m

inD

oora -t

o-G

roin

Pun

ctur

eti

me

60

min

ST

EM

Icon

firm

ed

card

iolo

gis

tno

tifi

ed

10

min

Doo

rto

ED

10

min

Doo

rto

ED

Inpa

ralle

lwit

hIV

rtP

Apa

thw

ay(1

0m

in)

ER

Tte

amis

noti

fied

asso

onas

larg

eto

med

ium

vess

eloc

clus

ion

issu

spec

ted

(ie

N

IHS

Sh

yper

dens

eM

CA

onC

T)in

elig

ible

pati

ents

10

min

afte

rth

eel

igib

ility

CT

scan

and

befo

reIV

bolu

s

Tran

sfer

from

outs

ide

hosp

ital

init

iate

dan

gio

suit

eac

tiva

ted

team

acti

vate

d

Pri

orto

arri

val

ED

stab

ilize

sp

atie

nta

ctiv

ates

cath

lab

30

min

Str

oke

team

acti

vati

on1

5m

inS

trok

ean

dE

RT

team

sac

tiva

tion

Inpa

ralle

lwit

hIV

rtP

Apa

thw

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5m

in)

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spit

alar

riva

lR

apid

hist

ory

and

exam

rev

iew

ofre

ferr

ing

hosp

ital

film

s

15

min

Cat

hla

ban

din

terv

enti

onal

ist

read

y

60

min

CT

scan

init

iate

d2

5m

inC

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itia

ted

Inpa

ralle

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rtP

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5m

in)

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ider

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vasc

ular

imag

ing

25

min

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CT

scan

and

afte

rIV

bolu

sin

itia

tion

Anc

illar

ybr

ain

imag

ing

(ie

CT

perf

usio

n)3

5m

in

Fin

alch

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and

wri

tten

cons

ent

70

min

CT

scan

inte

rpre

ted

elig

ibili

tyas

sess

ed4

5m

inC

Tsc

anin

terp

rete

del

igib

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asse

ssed

Inpa

ralle

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5m

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ain

wri

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ical

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min

afte

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ter

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PA

bolu

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Fin

alch

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cons

ent

pati

ent

prep

ped

45

min

Cat

hete

riza

tion

and

PC

Indashb

allo

onin

flat

ion

90

min

IVrt

PA

infu

sion

60

min

Gro

inpu

nctu

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0m

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punc

ture

60

min

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roin

punc

ture

60

min

Abb

revi

atio

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A

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ican

Hea

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onA

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io

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Str

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com

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tim

eof

arri

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cept

ing

hosp

ital

door

b

Tim

ew

illne

edto

bead

just

edto

allo

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rad

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onal

imag

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ifcl

inic

alex

amin

atio

nw

orse

nsor

sym

ptom

ssu

gges

the

mor

rhag

ictr

ansf

orm

atio

n










































































































































disclosures


























402761ndash2768












228





















26 2011
















2010411836ndash1840










































1999302598ndash2605








67334ndash336







11313ndash317








1175ndash1179



2718ndash2719









20111241250ndash1259











E1ndashE211





422983ndash2989








References


Citations






Reprints








Tab

le1

Dat

afr

omse

lect

edtr

ials

ofen

dov

ascu

lar

reva

scul

ariz

atio

nth

erap

yfo

rac

ute

isch

emic

stro

ke

PR

OA

CT

5P

RO

AC

TII

6E

MS

56IM

SI55

IMS

II40

ME

RC

I10M

ELT

12M

ulti

-ME

RC

I29P

enum

bra

PS

T11

Sol

itai

reA

Bp

ilot

stud

y24

Yea

r1

99

81

99

91

99

92

00

42

00

72

00

52

00

72

00

82

00

92

01

0

Inte

rven

tion

Pro

UK

IV

hepa

rin

vsIV

hepa

rin

pl

aceb

o(IA

salin

ein

fusi

on)

Pro

UK

IV

hepa

rin

vsIV

hepa

rin

IVtP

Aor

IVpl

aceb

ofo

llow

edby

IAtP

AIV

IA

tPA

IV

hepa

rin

IV

IAtP

A

IVhe

pari

nw

ith

orw

itho

utE

kos

Mer

ciX

6R

etri

ever

IV

hepa

rin

UK

vsco

ntro

lL5

Ret

riev

er

IVhe

pari

nP

enum

bra

aspi

rati

onsy

stem

IV

hepa

rin

Sol

itai

reA

Bm

echa

nica

lth

rom

bect

omy

Enr

ollm

ent

tim

eh

6

6

3

3

3

8

6

8

8

8

Des

ign

RC

TP

hase

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CT

Pha

seIII

RC

TP

hase

IS

ingl

ear

ms

afet

yan

dfe

asib

ility

Sin

gle

arm

saf

ety

and

feas

ibili

tyS

ingl

ear

m

Pro

spec

tive

RC

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ingl

ear

m

pros

pect

ive

Sin

gle

arm

pr

ospe

ctiv

eS

ingl

ear

ms

afet

yan

dfe

asib

ility

No

ofp

atie

nts

40

18

03

58

08

11

51

11

41

64

12

52

0

Rec

anal

izat

ion

rate

of

trea

tmen

tco

ntro

l5

81

46

61

85

51

05

66

0(T

ICI

TIM

I2ndash3

)4

67

45

76

9w

ith

adjt

x8

29

0

Occ

lusi

onsi

teM

CA

MC

AC

CA

IC

AM

CA

BA

ICA

MC

AV

AB

A

SC

AP

CA

AC

A

AIC

AP

ICA

ICA

MC

AV

AB

A

SC

AP

CA

AC

A

AIC

AP

ICA

ICA

MC

A

VA

BA

M

CA

ICA

MC

A

VA

BA

IC

AM

CA

VA

BA

IC

AM

CA

Mea

nN

IHS

S

trea

tmen

tco

ntro

l1

71

91

71

71

61

11

81

92

01

41

41

91

81

9

SIC

H

oftr

eatm

ent

cont

rol

15

71

09

21

18

56

69

97

89

29

81

12

10

mR

S0

ndash2at

90

day

s

oftr

eatm

ent

cont

rol

30

21

(mR

S0

ndash1at

90

days

)4

02

54

76

74

34

62

84

91

36

25

45

Abb

revi

atio

nsA

CA

an

teri

orce

rebr

alar

tery

adj

tx

adju

ncti

veth

erap

yA

ICA

an

teri

orin

feri

orce

rebe

llara

rter

yB

A

basi

lara

rter

yC

CA

co

mm

onca

roti

dar

tery

EM

S

Em

erge

ncy

Man

agem

ent

ofS

trok

eB

ridg

ing

Tria

lIA

in

tra-

arte

rial

IC

A

intr

acra

nial

inte

rnal

caro

tid

arte

ryI

MS

In

terv

enti

onal

Man

agem

ent

ofS

trok

etr

ial

MC

A

mid

dle

cere

bral

arte

ryM

ELT

M

iddl

ece

rebr

alar

tery

Em

bolis

mLo

cal

Fib

rino

lyti

cin

terv

enti

onTr

ial

ME

RC

IM

echa

nica

lEm

bolu

sR

emov

alin

Cer

ebra

lIsc

hem

iam

RS

m

odif

ied

Ran

kin

Sca

leN

IHS

S

NIH

Str

oke

Sca

leP

CA

po

ster

ior

cere

bral

arte

ryP

ICA

po

ster

ior

infe

rior

cere

bella

rar

tery

PR

OA

CT

P

roly

sein

Acu

teC

ereb

ralT

hrom

boem

bolis

mtr

ial

PS

T

Piv

otal

Str

oke

Tria

lR

CT

ra

ndom

ized

cont

rolle

dtr

ial

SC

A

supe

rior

cere

bella

rar

tery

SIC

H

sym

ptom

atic

intr

acra

nial

hem

orrh

age

TIC

Ith

rom

boly

sis

ince

rebr

alin

farc

tion

TIM

Ith

rom

boly

sis

inm

yoca

rdia

linf

arct

ion

tPA

ti

ssue

plas

min

ogen

acti

vato

rU

K

urok

inas

eV

A

intr

acra

nial

vert

ebra

lart

ery



































Imaging findings








History of ICH


Pregnancy



























Distal tothrombus






















urokinase







Tab

le4

Tre

atm

ent

tim

esin

sele

cted

stud

ies

inm

inut

es

Tri

alP

RO

AC

T5

PR

OA

CT

II6

IMS

I55IM

SII

I21E

MS

56M

ELT

12R

EC

AN

ALI

SE

41P

enum

bra

PS

T11

Mul

tiM

ER

CI29

M

ER

CI10

Wol

feet

al50

Doc

rocq

etal

54C

osta

lat

etal

43M

iley

etal

53S

uare

zet

al51

Mat

tle

etal

49F

lahe

rty

etal

52

No

ofsu

bje

cts

40

12

16

25

00

35

56

50

12

53

05

96

13

50

91

54

57

44

Tre

atm

ent

IApr

oUK

orpl

aceb

oIA

proU

KIV

-IA

rtP

AIV

aor

IV

IAb

IV-I

Aa

orIA

rtP

Ab

IAU

KIV

-IA

orIV

-IA

Trt

PA

IAT

IV

rtP

AIA

TIV

-IA

aor

IArt

PA

bIA

UK

IV-R

Sor

RS

alon

eIV

-IA

Tor

IAT

IAU

KIA

TU

KIV

IA

rtP

A

Tim

e-to

-doo

r1

14

Tim

e-to

-CT

MR

Isc

anm

ean

(med

ian)

Ons

et1

05

Ons

et1

62

(14

5)

Doo

r5

9(3

4)

Imag

ing

-to-

GP

16

1(1

53

)8

1(6

5)

CT

scan

-to-

mic

roca

thet

er1

74

Tim

e-to

-ER

Tin

itia

tion

oran

gio

gra

mor

GP

SO

(33

0)

SO

(31

8)

SO

21

7(2

12

)

SO

12

37

25

52

IV-b

olus

toG

P8

74

SO

a(1

98

)Oslash

b(1

80

)Oslash

SO

22

7S

O1

32

SO

25

8pound

SO

(25

8)

SO

a1

51

b2

61

SO

32

4(3

30

)S

O3

21

Doo

r(1

30

)S

O2

44

SO

(22

6)

GP

-to-

max

TIM

IT

ICI

54

(48

)

SO

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mor

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n










































































































































disclosures


























402761ndash2768












228





















26 2011
















2010411836ndash1840










































1999302598ndash2605








67334ndash336







11313ndash317








1175ndash1179



2718ndash2719









20111241250ndash1259











E1ndashE211





422983ndash2989








References


Citations






Reprints





































Imaging findings








History of ICH


Pregnancy



























Distal tothrombus






















urokinase







Tab

le4

Tre

atm

ent

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Tri

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inas

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Tab

le5

Ben

chm

ark

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inte

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Am

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lines

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68

Pro

pose

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ew

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edto

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alex

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atio

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sym

ptom

ssu

gges

the

mor

rhag

ictr

ansf

orm

atio

n










































































































































disclosures


























402761ndash2768












228





















26 2011
















2010411836ndash1840










































1999302598ndash2605








67334ndash336







11313ndash317








1175ndash1179



2718ndash2719









20111241250ndash1259











E1ndashE211





422983ndash2989








References


Citations






Reprints





























Imaging findings








History of ICH


Pregnancy



























Distal tothrombus






















urokinase







Tab

le4

Tre

atm

ent

tim

esin

sele

cted

stud

ies

inm

inut

es

Tri

alP

RO

AC

T5

PR

OA

CT

II6

IMS

I55IM

SII

I21E

MS

56M

ELT

12R

EC

AN

ALI

SE

41P

enum

bra

PS

T11

Mul

tiM

ER

CI29

M

ER

CI10

Wol

feet

al50

Doc

rocq

etal

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osta

lat

etal

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iley

etal

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uare

zet

al51

Mat

tle

etal

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lahe

rty

etal

52

No

ofsu

bje

cts

40

12

16

25

00

35

56

50

12

53

05

96

13

50

91

54

57

44

Tre

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n










































































































































disclosures


























402761ndash2768












228





















26 2011
















2010411836ndash1840










































1999302598ndash2605








67334ndash336







11313ndash317








1175ndash1179



2718ndash2719









20111241250ndash1259











E1ndashE211





422983ndash2989








References


Citations






Reprints





















Distal tothrombus






















urokinase







Tab

le4

Tre

atm

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tim

esin

sele

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stud

ies

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Tri

alP

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II6

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feet

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Mat

tle

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No

ofsu

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cts

40

12

16

25

00

35

56

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12

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91

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44

Tre

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IApr

oUK

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KIV

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IAU

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A

Tim

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(14

5)

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Tim

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98

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22

7S

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SO

25

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SO

(25

8)

SO

a1

51

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32

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30

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(48

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onT

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nfar

ctio

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K

urok

inas

e





Tab

le5

Ben

chm

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tim

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ble

inte

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Pro

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ital

door

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Tim

ew

illne

edto

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onal

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alex

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sym

ptom

ssu

gges

the

mor

rhag

ictr

ansf

orm

atio

n










































































































































disclosures


























402761ndash2768












228





















26 2011
















2010411836ndash1840










































1999302598ndash2605








67334ndash336







11313ndash317








1175ndash1179



2718ndash2719









20111241250ndash1259











E1ndashE211





422983ndash2989








References


Citations






Reprints









Tab

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mor

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orm

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n










































































































































disclosures


























402761ndash2768












228





















26 2011
















2010411836ndash1840










































1999302598ndash2605








67334ndash336







11313ndash317








1175ndash1179



2718ndash2719









20111241250ndash1259











E1ndashE211





422983ndash2989








References


Citations






Reprints







Tab

le5

Ben

chm

ark

tim

esfo

rre

vasc

ular

izat

ion

ther

apie

san

dp

ossi

ble

inte

rval

sfo

rE

RT

Am

eric

anC

olle

geof

Car

diol

ogy6

7A

SA

AH

AA

ISG

uide

lines

forI

Vrt

-PA

68

Pro

pose

dgo

als

forA

ISpa

tien

tsel

igib

lefo

rE

RT

pres

enti

ngto

ED

ldquoP

rim

ary

ER

TTi

merdquo

Pro

pose

dgo

als

forA

ISpa

tien

tsel

igib

lefo

rRes

cue

ER

Tfo

llow

ing

IVfa

ilure

ldquoIV

-Fai

lure

toR

escu

eE

RTrdquo

Pro

pose

dgo

als

forA

ISpa

tien

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ansf

erre

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rip-

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loon

tim

e9

0m

inD

oor-

to-n

eedl

eti

me

60

min

Doo

r-to

-gro

inpu

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me

90

min

Nee

dle

-to-

gro

inp

unct

ure

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e6

0m

inD

oora -t

o-G

roin

Pun

ctur

eti

me

60

min

ST

EM

Icon

firm

ed

card

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gis

tno

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ed

10

min

Doo

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ED

10

min

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Inpa

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thw

ay(1

0m

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ER

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ium

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(ie

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T)in

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Tran

sfer

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outs

ide

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ital

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dan

gio

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acti

vate

d

Pri

orto

arri

val

ED

stab

ilize

sp

atie

nta

ctiv

ates

cath

lab

30

min

Str

oke

team

acti

vati

on1

5m

inS

trok

ean

dE

RT

team

sac

tiva

tion

Inpa

ralle

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rtP

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thw

ay(1

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in)

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eivi

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alar

riva

lR

apid

hist

ory

and

exam

rev

iew

ofre

ferr

ing

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ital

film

s

15

min

Cat

hla

ban

din

terv

enti

onal

ist

read

y

60

min

CT

scan

init

iate

d2

5m

inC

Tsc

anin

itia

ted

Inpa

ralle

lwit

hIV

rtP

Apa

thw

ay(2

5m

in)

Ang

iosu

ite

acti

vate

dte

amon

stan

dby

cons

ider

noni

nvas

ive

vasc

ular

imag

ing

25

min

afte

rth

eel

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ility

CT

scan

and

afte

rIV

bolu

sin

itia

tion

Anc

illar

ybr

ain

imag

ing

(ie

CT

perf

usio

n)3

5m

in

Fin

alch

eck

and

wri

tten

cons

ent

70

min

CT

scan

inte

rpre

ted

elig

ibili

tyas

sess

ed4

5m

inC

Tsc

anin

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del

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asse

ssed

Inpa

ralle

lwit

hIV

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Apa

thw

ay(4

5m

in)

Rep

eat

NIH

SS

obt

ain

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tten

cons

ent

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atC

Tif

clin

ical

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seni

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min

afte

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Tsc

anan

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0m

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ter

the

IVrt

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s

Fin

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ent

prep

ped

45

min

Cat

hete

riza

tion

and

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Indashb

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onin

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90

min

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PA

infu

sion

60

min

Gro

inpu

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0m

inG

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min

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min

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A

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ican

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onA

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ang

io

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A

mer

ican

Str

oke

Ass

ocia

tion

ED

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iddl

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IHS

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IS

Tse

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onm

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ion

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rom

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arri

valt

oac

cept

ing

hosp

ital

door

b

Tim

ew

illne

edto

bead

just

edto

allo

wfo

rad

diti

onal

imag

ing

ifcl

inic

alex

amin

atio

nw

orse

nsor

sym

ptom

ssu

gges

the

mor

rhag

ictr

ansf

orm

atio

n










































































































































disclosures


























402761ndash2768












228





















26 2011
















2010411836ndash1840










































1999302598ndash2605








67334ndash336







11313ndash317








1175ndash1179



2718ndash2719









20111241250ndash1259











E1ndashE211





422983ndash2989








References


Citations






Reprints












































































































































disclosures


























402761ndash2768












228





















26 2011
















2010411836ndash1840










































1999302598ndash2605








67334ndash336







11313ndash317








1175ndash1179



2718ndash2719









20111241250ndash1259











E1ndashE211





422983ndash2989








References


Citations






Reprints


































































































































disclosures


























402761ndash2768












228





















26 2011
















2010411836ndash1840










































1999302598ndash2605








67334ndash336







11313ndash317








1175ndash1179



2718ndash2719









20111241250ndash1259











E1ndashE211





422983ndash2989








References


Citations






Reprints






























































































disclosures


























402761ndash2768












228





















26 2011
















2010411836ndash1840










































1999302598ndash2605








67334ndash336







11313ndash317








1175ndash1179



2718ndash2719









20111241250ndash1259











E1ndashE211





422983ndash2989








References


Citations






Reprints

















402761ndash2768












228





















26 2011
















2010411836ndash1840










































1999302598ndash2605








67334ndash336







11313ndash317








1175ndash1179



2718ndash2719









20111241250ndash1259











E1ndashE211





422983ndash2989








References


Citations






Reprints





























1999302598ndash2605








67334ndash336







11313ndash317








1175ndash1179



2718ndash2719









20111241250ndash1259











E1ndashE211





422983ndash2989








References


Citations






Reprints










References


Citations






Reprints




Documents

Developing practice recommendations for endovascular ... · Embolus Removal in Cerebral Ischemia (MERCI) and Multi-MERCI were prospective, single-arm, ... Randomized Clinical trial