SAPPHIRE
Stenting and Angioplasty with Protection in Patients and HIgh Risk for Endarterectomy
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Status:
Trial was stopped in June 2002 due to low enrollment. 30 day results presented in February 2003; two year follow-up presented June 2004. Trial results published in October of 2004. Three year follow-up results presented in October 2005.
Purpose:
To compare the safety and efficacy of the Cordis Nitinol Carotid Stent with the AngioGuard distal protective device to carotid endarterectomy (CEA) in treating carotid artery disease in high-risk patients. The study was designed to test the hypothesis that stenting was not inferior to endarterectomy.
Interventions:
Endarterectomy, carotid
Surgical therapy to remove atherosclerotic plaque in narrowed carotid arteries.
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Stent, carotid
Intravascular procedure to maintain carotid artery patency
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Year Presented:
2004
Design:
Eligible patients were randomized to receive either carotid endarterectomy or the protective stenting procedure.
Inclusion Criteria
Patients with symptomatic carotid-artery disease with >= 50% stenosis and patients with asymptomatic carotid-artery disease with >= 80 %, determined by color duplex ultrasonography. All patients were required to have at least one co-existing condition that potentially increased the risk posed by carotid endarterectomy (e.g., severe cardiac or pulmonary disease; age > 80, etc), but were judged potentially suitable for either endarterectomy or stenting.
>1 co-morbid condition
Team of vascular surgeon, neurologist and interventionalist determined if patient was too high risk for randomization; these patients were entered in a registry and not randomized.
Exclusion Criteria
Ischemic stroke within previous 48 hrs; presence of intraluminal thrombus; total occlusion of target carotid artery; life expectancy < 1 yr.
Patient Involvement:
Treatment with aspirin at a dose of 81 or 325 mg per day was begun at least 72 hours before stenting or endarterectomy and was continued indefinitely in both study groups. Both groups received intraprocedural heparin to maintain a therapeutic activated partial-thromboplastin time of 250 to 300 seconds. Patients undergoing stenting received clopidogrel (75 mg per day) starting 24 hours before the procedure and continuing for two to four weeks thereafter. Patients undergoing endarterectomy did not receive clopidogrel
Primary Outcome:
Cumulative incidence of a major cardiovascular event at one year: a composite of death, stroke or myocardial infarction within 30 days of intervention or ipsilateral stroke between 31 days and 1 year.
Secondary Outcome:
Target-vessel recanalization at one year, cranial nerve palsy, and complications at either the surgical or vascular access site.
Results:
The primary end point occurred in 20 patients randomly assigned to undergo carotid-artery stenting (CAS) with an emboli-protection device (cumulative incidence, 12.2%) and in 32 patients randomly assigned to undergo carotid endarterectomy (CEA)(cumulative incidence, 20.1%, absolute difference, 7.9%; 95 percent confidence interval, 16.4 to 0.7 %; P=0.004 for noninferiority, and P=0.053 for superiority).
At 36 months the incidence of stroke was virtually identical for both CAS and CEA (7.1% for CAS and 6.7% for CEA, P = 0.945), indicating that CAS is non-inferior to CEA. The 3-year incidence of stroke across the CAS treatment group members had only an average increase of 4.0% over the 30-day stroke rate.
Source of Information:
Presented at the 28th International Stroke Conference (February 2003). Presented at the 5th World Stroke Congress (June 2004). NEJM 2004; 351:1493-1501. Presented at the 2005 Transcatheter Cardiovascular Therapeutics meeting (October 2005).
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This information last updated on: 10/25/2005
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