Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy - SAPPHIRE

Oct 07, 2004
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Date Presented:
01/01/2002
Date Published:
01/01/2004
Date Updated:
10/07/2004
Original Posted Date:
10/07/2004
References

Description:

The goal of the trial was to compared stenting with protection vs endarterectomy in patients with severe symptomatic or asymptomatic atherosclerotic carotid artery stenosis.

Hypothesis:

The rate of the composite endpoint of death, myocardial infarction (MI), or stroke at 30 days plus ipsilateral stroke or death from neurologic causes within 31 days to 1 year will differ between the stent arm and the endarterectomy arm.

Study Design

Study Design:

Patients Enrolled: 334
Mean Follow Up: 3 years
Mean Patient Age: Mean age 72
Female: 33

Patient Populations:

>=50% stenosis in symptomatic patients; >=80% stenosis in asymptomatic patients; >=1 comorbid condition.

Exclusions:

Ongoing stroke; total occlusion of the artery; recent percutaneous or surgical intervention; ostial lesions.

Primary Endpoints:

Composite of death, stroke, or MI at 30 days plus ipsilateral stroke or death from neurologic causes within 31 days to 1 year

Secondary Endpoints:

Death, stroke, or MI at 1 year; major adverse cardiac events (MACE) to 3 years.

Drug/Procedures Used:

Patients were randomized to either stenting (n=167) with protection or endarterectomy (CEA) (n=167). A team of an interventionalist, vascular surgeon, and neurologist determined if the patient was too high risk to be randomized in the trial and was then entered in a registry.

Principal Findings:

The trial was stopped early due to low enrollment. The rate of the composite endpoint of death, MI, or stroke at 30 days plus ipsilateral stroke or death from neurologic causes within 31 days to 1 yr) was non-inferior in the stent arm compared with the CEA arm (12.2% vs 20.1%, p=0.004 for noninferiority; p=0.053 for superiority). While the directionality of the individual endpoints at 1 year all favored stenting, none reached significance (death 7.4% vs 13.5%, p=0.08; MI 3.0% vs 7.5%, p=0.07; stroke 6.2% vs 7.9%, p=0.60). In a stratified analysis by symptomatic status, there was no difference in the primary composite endpoint at 1 year in patients with symptomatic carotid artery stenosis (16.8% vs 16.5%, p=0.95) but the event rate was lower in asymptomatic patients in the stent group (9.9% vs 21.5%, p=0.02). There was no significant difference in transient ischemic attack or major bleed between the 2 arms, but the rate of cranial nerve injury was higher in the CEA arm (0% vs 4.9%, p<0.01).

Interpretation:

Among patients with severe atherosclerotic carotid artery stenosis, treatment with stenting was non-inferior compared to carotid endarterectomy for the composite of death, stroke, or MI at 30 days plus ipsilateral stroke or death from neurologic causes within 31 days to 1 year. The SAPPHIRE trial was the first randomized trial to compare CEA with stenting in this patient population. Although the trial was discontinued prematurely, non-inferiority was observed between the stent and CEA arms. Long-term results of the trial through 3 years are pending.

References:

Yadav JS, et al. Protected Carotid-Artery Stenting versus Endarterectomy in High-Risk Patients. N Engl J Med 2004;351:1493-501.

Presented at AHA 2002, late breaking clinical trials.

Keywords: Registries, Myocardial Infarction, Stroke, Ischemic Attack, Transient, Endarterectomy, Carotid, Cranial Nerve Injuries, Carotid Stenosis, Stents


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