Stenting and Angioplasty with Protection in Patients at High-Risk for Endarterectomy Presented by...
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Stenting and Angioplasty with Protection in Patients Stenting and Angioplasty with Protection in Patients at High-Risk for Endarterectomyat High-Risk for Endarterectomy
Stenting and Angioplasty with Protection in Patients Stenting and Angioplasty with Protection in Patients at High-Risk for Endarterectomyat High-Risk for Endarterectomy
Presented by Jay Yadav, MD on behalf of the Presented by Jay Yadav, MD on behalf of the SAPPHIRE InvestigatorsSAPPHIRE Investigators
AHA 2002AHA 2002
SAPPHIRE TrialSAPPHIRE Trial
www. Clinical trial results.org
SAPPHIRESAPPHIRE
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 AStenting with protection
(n = 156)
Treatment Group AStenting with protection
(n = 156)
Treatment Group BCarotid endarterectomy
(n = 151)
Treatment Group BCarotid endarterectomy
(n = 151)
Endpoints: Primary – 30 day Death, Stroke or MI
Endpoints: Primary – 30 day Death, Stroke or MI
Yadav et al, AHA 2002Yadav et al, AHA 2002
www. Clinical trial results.org
5.8%
12.6%
0%
5%
10%
15%
5.8%
12.6%
0%
5%
10%
15%
StentStent CEACEA
P=0.047P=0.047Death / MI / StrokeDeath / MI / Stroke
SAPPHIRE: Primary Endpoint: Primary EndpointSAPPHIRE: Primary Endpoint: Primary Endpoint
Yadav et al, AHA 2002Yadav 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
4.2%
15.4%
0%
5%
10%
15%
20%
4.2%
15.4%
0%
5%
10%
15%
20% P=0.13P=0.13Death / MI / Stroke Death / MI / Stroke
SAPPHIRE: Primary Endpoint by Symptom Status: Primary Endpoint by Symptom StatusSAPPHIRE: Primary Endpoint by Symptom Status: Primary Endpoint by Symptom Status
SymptomaticSymptomatic
6.7%
11.2%
0%
5%
10%
15%
20%
6.7%
11.2%
0%
5%
10%
15%
20% P=0.33P=0.33Death / MI / StrokeDeath / MI / Stroke
AsymptomaticAsymptomatic
Yadav et al, AHA 2002Yadav et al, AHA 2002
StentStent CEACEA
n=48 n=39
StentStent CEACEA
n=104 n=98
