Endarterectomy versus Stenting in Endarterectomy versus Stenting in Patients with Symptomatic Severe Patients with Symptomatic Severe

Carotid StenosisCarotid Stenosis

Dr. Quan, Dr. Mirhashemi, Dr. Dr. Quan, Dr. Mirhashemi, Dr. ChiangChiang

N Engl J Med 2006; 355:1660-71

ObjectiveObjective

1.1. Know when to send patients for Know when to send patients for carotid artery stenting vs carotid artery stenting vs endarterectomyendarterectomy

2.2. Learn about Relative RiskLearn about Relative Risk

3.3. Know when is Relative Risk Know when is Relative Risk significantsignificant

OverviewOverview

Step 1 – Get patients with Step 1 – Get patients with symptomatic carotid stenosissymptomatic carotid stenosis

Step 2 – Send patients to have Step 2 – Send patients to have carotid stenting or carotid stenting or endarterectomyendarterectomy

Step 3 – Evaluate 30-day stroke Step 3 – Evaluate 30-day stroke or death of both groupsor death of both groups

PurposePurpose

To evaluate the efficacy of To evaluate the efficacy of carotid stenting vs carotid stenting vs endarterectomy in patients with endarterectomy in patients with symptomatic carotid-artery symptomatic carotid-artery stenosisstenosis

Time and PlaceTime and Place

November 2000 to September November 2000 to September 20052005

20 academic and 10 non-20 academic and 10 non-academic centers in Franceacademic centers in France

Approved by ethics committee Approved by ethics committee

Centers and Centers and InvestigatorsInvestigators

1+ Neurologist1+ Neurologist 1+ Vascular Surgeon1+ Vascular Surgeon

Performed 25 endarterectomiesPerformed 25 endarterectomies 1+ Interventional Physician1+ Interventional Physician

Performed 12 carotid-stenting orPerformed 12 carotid-stenting or Performed 35 stenting procedures Performed 35 stenting procedures

in supraaortic trucks (5 in carotid in supraaortic trucks (5 in carotid artery)artery)

PatientsPatients

18+ years old18+ years old Hemispheric or retinal TIA or Hemispheric or retinal TIA or

nondisabling stroke within 120 nondisabling stroke within 120 daysdays

Carotid Artery Stenosis of 60 to Carotid Artery Stenosis of 60 to 99%99% Confirmed by angiography or both Confirmed by angiography or both

duplex scanning and MRAduplex scanning and MRA

Reference: http://neuro.wehealny.org/endo/proc_stents-angioplasty.asp

Reference: http://www.diagnosticclinic.com/health/articles/images/MRA/carotid_stenosis.jpg

Excluded PatientsExcluded Patients

Modified Rankin score of 3+Modified Rankin score of 3+ Nonatherosclerotic carotid Nonatherosclerotic carotid

diseasedisease Severe tandem lesions (proximal Severe tandem lesions (proximal

common carotid artery or common carotid artery or intracranial artery that was more intracranial artery that was more severe than carotid lesion)severe than carotid lesion)

Previous revascularizationPrevious revascularization History of bleeding disorderHistory of bleeding disorder

Excluded PatientsExcluded Patients

Uncontrolled HTN or DMUncontrolled HTN or DM Unstable AnginaUnstable Angina Contraindication to heparin, Contraindication to heparin,

ticlopidine, or clopidogrelticlopidine, or clopidogrel Life expectancy of less than 2 Life expectancy of less than 2

yearsyears Percutaneous or surgical Percutaneous or surgical

intervention within 30 days intervention within 30 days

Standard ProceduresStandard Procedures

Surgeons performed Surgeons performed endarterectomy according to endarterectomy according to customary practicecustomary practice

Carotid stenting via femoral Carotid stenting via femoral route with the use of cerebral route with the use of cerebral protection device (01/2003 protection device (01/2003 approved by safety committee)approved by safety committee)

Cerebral Protection Cerebral Protection DeviceDevice

Reference: http://radinfo.musc.edu/Interventional/index.php?module=pagemaster&PAGE_user_op=view_page&PAGE_id=58

EndarterectomyEndarterectomy

Reference: http://radinfo.musc.edu/Interventional/index.php?module=pagemaster&PAGE_user_op=view_page&PAGE_id=58

AnticoagulationAnticoagulation

Aspirin 100-300mg qdAspirin 100-300mg qd Clopidogrel 75 mg qd or Clopidogrel 75 mg qd or Ticlopidine 500mg qdTiclopidine 500mg qd

Take 3 days before and 30 days Take 3 days before and 30 days after stentingafter stenting

Follow-upFollow-up

48 hours48 hours 30 days30 days 6 months after treatment6 months after treatment Then every 6 months thereafterThen every 6 months thereafter

End PointsEnd Points

Any stroke or death occurring Any stroke or death occurring within 30 days after treatmentwithin 30 days after treatment

ResultsResults

Predicted StatisticsPredicted Statistics

Require 872 patients whether Require 872 patients whether stenting was not inferior to stenting was not inferior to endarterectomy with regard to endarterectomy with regard to the 30-day incidence of stroke or the 30-day incidence of stroke or deathdeath

Expected 30-day incidence of Expected 30-day incidence of stroke or death (Endarterectomy stroke or death (Endarterectomy 5.6%, Stent 4%)5.6%, Stent 4%)

Local InjuriesLocal Injuries

Cranial-nerve injury was Cranial-nerve injury was significantly more common after significantly more common after endarterectomy than after endarterectomy than after stenting (7.7% vs 1.1%, stenting (7.7% vs 1.1%, P<0.001)P<0.001)

Median hospital stay (stent, 3 Median hospital stay (stent, 3 days, endarterectomy – 4 days, days, endarterectomy – 4 days, P=0.01)P=0.01)

WeaknessWeakness

by Dr. Mirhashemi by Dr. Mirhashemi

StrengthsStrengths

Baseline patients characteristics Baseline patients characteristics in stenting vs endarterectomy in stenting vs endarterectomy are statistical similarare statistical similar

Adjusted Relative RiskAdjusted Relative Risk

Age – 2.4Age – 2.4 History of stroke – 2.6History of stroke – 2.6

More patients in the stenting More patients in the stenting group had contralateral carotid group had contralateral carotid occlusion; none of them had a occlusion; none of them had a stroke after stentingstroke after stenting

StrengthStrength

Computer-generated sequence Computer-generated sequence randomly assigned to undergo randomly assigned to undergo endarterectomy or stentingendarterectomy or stenting

Operator independent Operator independent

Learning CurveLearning Curve

No significant differences in No significant differences in outcome related to the number of outcome related to the number of stenting procedures performed in stenting procedures performed in individual centers or to the individual centers or to the experience of the interventional experience of the interventional physiciansphysicians

Experience with any new device Experience with any new device was required before its use in the was required before its use in the trialtrial

Effects of Cerebral Effects of Cerebral ProtectionProtection

30-day incidence of stroke or 30-day incidence of stroke or death was lower among patients death was lower among patients who underwent stenting with who underwent stenting with cerebral protection (7.9%) than cerebral protection (7.9%) than stenting alone (25%)stenting alone (25%)

However, the RR over However, the RR over endarterectomy did not differ endarterectomy did not differ significantly (2.0 before and 3.4 significantly (2.0 before and 3.4 after)after)

Antiplatelet TherapyAntiplatelet Therapy

30-day incidence of stroke or 30-day incidence of stroke or death after stenting didn’t differ death after stenting didn’t differ significantly between pts who significantly between pts who received dual antiplatelet received dual antiplatelet therapy (19 of 211, 9.0%) and therapy (19 of 211, 9.0%) and those who received single those who received single antiplatelet therapy (4 of 36, antiplatelet therapy (4 of 36, 11.1%, P=0.75)11.1%, P=0.75)

StrengthsStrengths

The events committee assess the The events committee assess the occurrence of stroke, death, and occurrence of stroke, death, and other outcomes, unaware of the other outcomes, unaware of the treatment assignmentstreatment assignments

DiscussionDiscussion

Lower surgical risk in our studyLower surgical risk in our study Previous trials – 30-day incidence Previous trials – 30-day incidence

of stroke or death after of stroke or death after endovascular repair of the endovascular repair of the carotid artery is 8.1% (51 of 632)carotid artery is 8.1% (51 of 632)

StentingStenting

30-day incidence of stroke after 30-day incidence of stroke after stenting in our study 9.2% which stenting in our study 9.2% which was higher than SAPPHIRE trial was higher than SAPPHIRE trial 3.6% (most patients had 3.6% (most patients had asymptomatic stenosis)asymptomatic stenosis)

Safety and FutilitySafety and Futility

September 2005, safety September 2005, safety committee recommended committee recommended stopping enrollment due to stopping enrollment due to increased risk of stroke or death increased risk of stroke or death after stenting and requiring to after stenting and requiring to enroll more than 4000 patients enroll more than 4000 patients to test the noninferiority of to test the noninferiority of stentingstenting

ConclusionConclusion

Patients with symptomatic Patients with symptomatic carotid stenosis of 60% or more, carotid stenosis of 60% or more, treatment with endarterectomy treatment with endarterectomy results in lower rates of stroke or results in lower rates of stroke or death at 30days and 6 months death at 30days and 6 months than does stenting.than does stenting.

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