SAPPHIRE Trial Stenting and Angioplasty with Protection in

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 g g >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: g Primary – 30 day Death, Stroke or MI www. Clinical trial results. org Yadav et al, AHA 2002

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=156 n=151 Stent CEA www. Clinical trial results. org Yadav et al, AHA 2002

SAPPHIRE: Primary Endpoint by Symptom Status Symptomatic Death / MI / Stroke Asymptomatic Death / MI / Stroke P=0. 33 P=0. 13 n=48 n=39 n=104 n=98 Stent CEA www. Clinical trial results. org Yadav et al, AHA 2002