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

SAPPHIRE Trial. Stenting and Angioplasty with Protection in Patients at High-Risk for Endarterectomy. Presented by Jay Yadav, MD on behalf of the SAPPHIRE Investigators AHA 2002. SAPPHIRE. 723 patients with high risk for CEA > 50% stenosis in symptomatic patients

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

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  1. SAPPHIRE Trial Stenting and Angioplasty with Protection in Patients at High-Risk for Endarterectomy Presented by Jay Yadav, MD on behalf of the SAPPHIRE Investigators AHA 2002

  2. SAPPHIRE • 723 patients with high risk for CEA • >50% stenosis in symptomatic patients • >80% stenosis in asymptomatic patients • >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 Treatment Group A Stenting with protection (n = 156) Treatment Group B Carotid endarterectomy (n = 151) • Endpoints: • Primary – 30 day Death, Stroke or MI Yadav et al, AHA 2002

  3. SAPPHIRE: Primary Endpoint Death / MI / Stroke P=0.047 • The trial was discontinued early due to low enrollment • However, despite the lower than expected enrollment, the rate of the 30 day composite primary endpoint was lower in the stent arm vs the CEA arm n=151 n=156 CEA Stent Yadav et al, AHA 2002

  4. SAPPHIRE: Primary Endpoint by Symptom Status Asymptomatic Symptomatic Death / MI / Stroke Death / MI / Stroke P=0.33 P=0.13 n=98 n=104 n=39 n=48 Stent CEA CEA Stent Yadav et al, AHA 2002

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