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 Trial

www. Clinical trial results.org 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 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 A Stenting with protection (n = 156) Treatment Group B Carotid endarterectomy (n = 151) Treatment Group B Carotid endarterectomy (n = 151) Endpoints:  Primary – 30 day Death, Stroke or MI Endpoints:  Primary – 30 day Death, Stroke or MI Yadav et al, AHA 2002

www. Clinical trial results.org Stent CEA P=0.047 Death / MI / Stroke : Primary Endpoint SAPPHIRE : Primary Endpoint Yadav et al, AHA 2002 n=156 n=151 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 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

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