Cardiologie

1Primary PCI VS Thrombolysis inSTEMI, Positional Statement

Primary PCI VS Thrombolysis inSTEMI, Positional Statement

Ahmed Magdy, MD, FACC, FSCAINational Heart

Institute

Change in Approach to AMIChange in Approach to AMI

19902002 20032011

AcuteMI

Lytic

AcuteMI

FacilitatedLytic/LMWH

Transfer for Cath with Lytic failureTransfer emergently all patients

22007 focused update of the ACC/AHA STEMI guidelines

Reperfusion Therapy in STEMI

3Importance of Rapid Time toTreatment With Fibrinolysis in STEMI

Importance of Rapid Time toTreatment With Fibrinolysis in STEMI

33 55% %

44..00Ab

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Abso

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t 35 35

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sda

ys 33..55% %

2.5% 2.5%

1.8%1.8% 1.6% 1.6%

1.01.0

33..00

2.02.0

Time from onset of symptoms to treatment (hours)Time from onset of symptoms to treatment (hours)

00..55% % 0.00.0 0 0 11 2 2 33 4 4 66 7 7 1212 12 12 2424

The Fibrinolytics Therapy Trialists collaborative group. The Fibrinolytics Therapy Trialists collaborative group. LancetLancet. . 19941994;; 343343::311311. .

PCI In-hospital Mortality vs Door to Balloon TimePCI In-hospital Mortality vs Door to Balloon Time

12.214

4.96.1

8

4

6

8

10

12

In-hospDeath

N= 2,322

0

2

Door to Balloon Time (hours)

DeathRate

0-1.4 1.5-1.9 2.0-2.9 >3.0

Brodie BR, JACC 47, 2006

N=384 N=493 N=750 N=673

4(%)

(%)

DD

100100

8080

III. Timely Reperfusion1. Time is Myocardium

2. Infarct Size is Outcome

Symptom onset to hospArrival 2 hr Shift i t ith

BB

CC

AAExtent ofExtent ofMyocardial SalvageMyocardial Salvage

Mor

talit

y R

educ

tion

Mor

talit

y R

educ

tion

6060

4040

2020

Arrival 2 hr

Thrombolysis given, 2 hr

lysis induced reperfusion 3 hr onset to balloon 3 hr

Shifts in outcome with different ttt strategiesA to B no benefitA to C BenefitB to C BenefitD to B HarmD to C Harm

Myocardial SalvageMyocardial Salvage0000 44 88 1212 1616 2020 2424

Time From Symptom Onset to Reperfusion Therapy, hTime From Symptom Onset to Reperfusion Therapy, h

Critical TimeCritical Time--dependent Perioddependent PeriodGoal: Myocardial SalvageGoal: Myocardial Salvage

TimeTime--independent Periodindependent PeriodGoal: Open InfarctGoal: Open Infarct--Related ArteryRelated Artery

Gersh BJ, et al. Gersh BJ, et al. JAMAJAMA. . 20052005;;293293::979979..

Primary PCI vs Lysis for STEMI Meta-analysis of 23 trials

Primary PCI vs Lysis for STEMI Meta-analysis of 23 trials

PCI is better than LYSIS!

2468

10121416

PTCAThrombolytic

P=0.0003P

5Recent Influences of PracticeSalvage is Time Dependant

Recent Influences of PracticeSalvage is Time Dependant

Superiority of PPCI over fibrinolysis if Door-Superiority of PPCI over fibrinolysis if Doorto-Balloon completed in a timely fashion

Acknowledgement that Time Matters in PPCIg Recommendations for time to reperfusion updated

Mortality rates with primary PCI as a function of PCI-related time delay

ce in

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15 Circle sizes = sample size of the

P = 0.006

ute

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individual study.Solid line= weighted meta-regression.

62 min

BenefitFavors PCI

BenefitFavors PCIHH

0 20 40 60 80 100PCI-Related Time Delay (door-to-balloon - door to needle)

Abs

olu

Abs

olu

-5

Nallamothu BK, Bates ER. Am J Cardiol. 2003;92:824-6

HarmFavors Lysis

HarmFavors Lysis

For Every 10 min delay to PCI: 1% reduction in mortality difference towards lytics

6*PPCI Better > Pre-Hospital Lysis > In-Hospital Lysis

*PPCI Better > Pre-Hospital Lysis > In-Hospital Lysis

*Transfer for PCI is better than LYSIS! (In a timely manner)

*Transfer for PCI is better than LYSIS! (In a timely manner)

7Assessing Reperfusion Options for Patients with STEMI1

Assessing Reperfusion Options for Patients with STEMI1

STEP 1: Assess time from symptom onset, risk of STEMI, risk of thrombolysis, time for transport to PCI lab

STEP 2: Determine whether fibrinolysis or invasive strategy is preferred*

FibrinolysisFibrinolysis preferred if:preferred if: Invasive strategy preferred if:Invasive strategy preferred if: Early presentation (3 hours) Late presentation (>3 hours)Late presentation (>3 hours) Diagnosis of STEMI is in doubtDiagnosis of STEMI is in doubt

*If presentation is

8PCI post thrombolysis in STEMI:PCI post thrombolysis in STEMI:

Prehospital TL+ immediate transfer

Delayed PCIb f di h immediate transfer

Rescue PCIfor failed TL

9PCI post thrombolysis in STEMI: RATIONALE

PCI post thrombolysis in STEMI: RATIONALE

1 Ri k f reocclusion hi h1. Risk of reocclusion high2. Early angiographic risk stratification3. High likelihood of residual complex

stenosis despite successful TL Rxstenosis despite successful TL Rx

REACT: 6 month Primary compositeREACT: 6 month Primary composite(Death, MI, CVA, or severe heart failure)

Rescue PCI is better than Lysis!!

31.0

15.3

29.8

15

20

25

30

35

%

The primary composite endpoint of death, MI, CVA or severe heart failure at 6 months was significantly lower in the rescue PCI group compared

p

10

PCI i b tt th

PCI i b tt this better than

Facilitated PCI????

is better than Facilitated PCI

????

12

Primary, secondary and bleeding end points in FINESSE

Primary, secondary and bleeding end points in FINESSE

End pointsEnd points Primary Primary PCI (%) PCI (%)

AbciximabAbciximab+PCI%) +PCI%)

(abcixima/(abcixima/reteplase)reteplase)--facilitated PCI facilitated PCI (%)(%)

p, p, combined+ combined+ PCI vs PCI vs primary PCI primary PCI

p, combin p, combin +PCIvs +PCIvs abciximababciximab--facilitate facilitate (%) (%)

Primary end Primary end point* point*

10.710.7 10.510.5 9.89.8 NSNS NSNS

AllAll--cause cause mortality mortality

4.54.5 5.55.5 5.25.2 NSNS NSNS

Complications Complications of MI of MI

8.98.9 7.57.5 7.47.4 NSNS NSNS

Death Death 4.54.5 5.55.5 5.25.2 NSNS NSNS

TIMI major TIMI major bleeding bleeding

2.62.6 4.14.1 4.84.8 0.0250.025 NSNS

TIMI minor TIMI minor bleeding bleeding

4.34.3 6.06.0 9.79.7

13

Immediate PCIImmediate PCIImmediate PCI is better than

LYSIS +/- Delayed PCI!

Immediate PCI is better than

LYSIS +/- Delayed PCI!

14

SIAM SIAM 3 3 Event Free SurvivalEvent Free Survival

(Death, Re(Death, Re--infarction, Intervention, Ischemia)infarction, Intervention, Ischemia)

SIAM SIAM 3 3 Event Free SurvivalEvent Free Survival

(Death, Re(Death, Re--infarction, Intervention, Ischemia)infarction, Intervention, Ischemia)

15

Pharmacoinvasive (Facilitated) PCI

Pharmacoinvasive (Facilitated) PCI(Facilitated) PCI

is better than Lytic +Rescue PCI

(Facilitated) PCI is better than Lytic +

Rescue PCI

17

Comments on CARESSComments on CARESS

Again use of potent antiplatelet agent Again use of potent antiplatelet agent (abciximab), platelets inactivated at time of PCI, (In ASSENT IV < 10% use!!)

Bleeding reassuring as pts > 75yo excluded Median time from TL Rx to PCI 212 minMedian time from TL Rx to PCI 212 min

Post-Lysis PCI studiesPost-Lysis PCI studies

50 660 GRACIAGRACIA--11SIAM IIISIAM III CAPITAL MICAPITAL MI CARESSCARESS

25.6

50.6

2124.4

20

30

40

50 PCI"Conservative"N=N=14361436

9 11.64.1

11.1

0

10

20

refractIs/D/MI/TLR

D/MI/Revasc D/MI/UA/stoke refract Is/D/MI

P=0.001 P=0.0008 P=0.04 P=0.001

18

CommunityCommunityHospitalHospitalEmergencyEmergency

TNK + ASA + Heparin / Enoxaparin + ClopidogrelTNK + ASA + Heparin / Enoxaparin + Clopidogrel

PharmacoinvasivePharmacoinvasiveStrategyStrategy

High Risk ST Elevation MI within High Risk ST Elevation MI within 12 12 hours of symptom onsethours of symptom onset

Standard TreatmentStandard Treatment

PCI CentrePCI Centre

EmergencyEmergencyDepartmentDepartment

CathCath / PCI within 6 hrs / PCI within 6 hrs regardless of regardless of

reperfusion statusreperfusion status

Cath and Rescue Cath and Rescue PCI PCI GP IIb/IIIa GP IIb/IIIa

InhibitorInhibitor

gygyUrgentUrgent Transfer to PCI CentreTransfer to PCI Centre

Assess chest pain, STAssess chest pain, ST resolutionresolutionat at 6060--90 90 minutes after randomizationminutes after randomization

Failed Reperfusion*Failed Reperfusion* Successful ReperfusionSuccessful Reperfusion

Elective Cath Elective Cath PCIPCI

>> 2424 hrs laterhrs laterPCI CentrePCI CentreCath LabCath Lab

reperfusion statusreperfusion status InhibitorInhibitor > > 24 24 hrs laterhrs later

* ST segment resolution < 50% & persistent chest pain, or hemodynamic instability* ST segment resolution < 50% & persistent chest pain, or hemodynamic instability

Repatriation of stable patients within 24 hrs of PCI

Randomization stratified by age (Randomization stratified by age (75 75 vs. > vs. > 7575) and by enrolling site) and by enrolling site

141416161818 1616..66

% of Patients% of Patients

Primary Endpoint: Primary Endpoint: 3030--Day Death, reDay Death, re--MI, MI, CHF, Severe Recurrent Ischemia, CHF, Severe Recurrent Ischemia,

Shock Shock

446688

101012121414

1010..66

Standard PCI > 24 hrs (n=496)Standard PCI > 24 hrs (n=496)

OR=0.537 (0.368, 0.783); p=0.0013

0022

00 55 1010 1515 2020 2525 3030Days from RandomizationDays from Randomization

Invasive < 6 hrs (n=508)Invasive < 6 hrs (n=508)

n=496n=496n=508n=508

422422468468

415415466466

415415463463

414414461461

414414460460

412412457457

19

SummarySummary Pharmacoinvasive Strategy of routine early

PCI within 6 hrs after thrombolysis is associated with a 6% absolute (46% relative) ( )reduction in the composite of death, re-MI, recurrent ischemia, HF and shock

is not associated with any increase in transfusions, severe bleeding despite high

f GP IIb/III i PCIuse of GP IIb/IIIa in PCI Benefit seen despite high cath/PCI rates in

Standard Treatment group (including ~40% rescue PCI)

20

Observational prospective database (July 2007

Thrombolysis catching up with PCI in STEMI, especially in lower-risk patientsThrombolysis catching up with PCI in

STEMI, especially in lower-risk patients

to December 2009) of patients with STEMI admitted to 73 Belgian hospitals: 25 hospitals had PCI facilities and 48 hospitals did not.

Outcome was in-hospital mortality, and patients were stratified into low intermediate andwere stratified into low, intermediate, and high risk according to TIMI score.

Arch Intern Med 2011; 171: 544-9

21

Thrombolysis catching up with PCI in STEMI, especially in lower-risk

patients

Thrombolysis catching up with PCI in STEMI, especially in lower-risk

patients

There were 5 295 eligible patients in the There were 5,295 eligible patients in the registry, 4,574 (86.4%) were treated with primary PCI and 721 (13.6%) received thrombolysis. Of those receiving thrombolysis, 603 (83.6%) underwent subsequent invasive

l i TIMI i k l ievaluation. TIMI risk scores were low in 1,934, intermediate in 2,382, and high in 979.

Arch Intern Med 2011; 171: 544-9

In hospital mortality was similar in the two

Thrombolysis catching up with PCI in STEMI, especially in lower-risk patientsThrombolysis catching up with PCI in

STEMI, especially in lower-risk patients

In-hospital mortality was similar in the two groups, 5.9% (PCI) vs. 6.6%, and after adjustment for baseline risk profile the difference was significant only in the high-risk group

22

The authors conclude that in current practice

The authors conclude that in current practice

thrombolysis is normally followed by invasive y y yintervention, immediate PCI only has an advantage for in-hospital mortality in patients at high risk.

Early thrombolysis followed by later invasive l ti t b i t d l d PCIevaluation seems to be superior to delayed PCI

when door to balloon time is over 60 minutes.

In summary: European GLIn summary: European GL

23

(From 2007 STEMI Update, Section 5)(From 2007 STEMI Update, Section 5)

1. Facilitated PCI using regimens other than full-dosefib i l ti th i ht b id dfibrinolytic therapy might be considered as a reperfusion strategy when all of the following are present: a. Patients are at high risk, b. PCI is not immediately available within 90 yminutes, c. Bleeding risk is low (younger age, absence of poorly controlled hypertension, normal body weight). (Level of Evidence: C)

2009 Joint STEMI/PCI Focused Update2009 Joint STEMI/PCI Focused Update Class IIa1. It is reasonable for high-risk* patients who receive

fibrinolytic therapy as primary reperfusion therapy at a non PCI capable facility to be transferred asnonPCI-capable facility to be transferred as ASAP to a PCI-capable facility where PCI can be performed either when needed or as a pharmaco-invasive strategy.

Consideration should be given to initiating a preparatory antithrombotic (anticoagulant plus antiplatelet) regimen before and during patient transfer to the catheterization laboratory (14,15).

(Level of Evidence: B)

24

Both Discourage Facilitated Reperfusion Both Endorse Newer Anticoagulants

" bl " t f

Latest European and US STEMI Guidelines Compared and Contrasted

Latest European and US STEMI Guidelines Compared and Contrasted

both note it would be "reasonable" to perform early angiography for risk stratification in patients not undergoing primary PCI, but the ESC goes a step further by supporting routine angiography (with PCI if indicated) 3 to 24 hours after successful fibrinolysis based on several recent studies, including the GRACIA trials.

What conclusions can we make!What conclusions can we make!

PCI centers should do PCI (in a timely manner

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Cardiologie