Stenting and Angioplasty with Protection in Patients at High-Risk for Endarterectomy Presented by...
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![Page 1: Stenting and Angioplasty with Protection in Patients at High-Risk for Endarterectomy Presented by Jay Yadav, MD on behalf of the SAPPHIRE Investigators.](https://reader038.fdocuments.net/reader038/viewer/2022100501/56649d195503460f949ee474/html5/thumbnails/1.jpg)
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
![Page 2: Stenting and Angioplasty with Protection in Patients at High-Risk for Endarterectomy Presented by Jay Yadav, MD on behalf of the SAPPHIRE Investigators.](https://reader038.fdocuments.net/reader038/viewer/2022100501/56649d195503460f949ee474/html5/thumbnails/2.jpg)
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
![Page 3: Stenting and Angioplasty with Protection in Patients at High-Risk for Endarterectomy Presented by Jay Yadav, MD on behalf of the SAPPHIRE Investigators.](https://reader038.fdocuments.net/reader038/viewer/2022100501/56649d195503460f949ee474/html5/thumbnails/3.jpg)
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
![Page 4: Stenting and Angioplasty with Protection in Patients at High-Risk for Endarterectomy Presented by Jay Yadav, MD on behalf of the SAPPHIRE Investigators.](https://reader038.fdocuments.net/reader038/viewer/2022100501/56649d195503460f949ee474/html5/thumbnails/4.jpg)
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