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
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
Stent
CEA
P=0.047
Death / MI / Stroke
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
P=0.13
Death / MI / Stroke
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