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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 > 50% stenosis in symptomatic patients

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stenting and angioplasty with protection in patients at high risk for endarterectomy

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

slide2

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

sapphire primary endpoint
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=151

n=156

CEA

Stent

Yadav et al, AHA 2002

sapphire primary endpoint by symptom status
SAPPHIRE: Primary Endpoint by Symptom Status

Asymptomatic

Symptomatic

Death / MI / Stroke

Death / MI / Stroke

P=0.33

P=0.13

n=98

n=104

n=39

n=48

Stent

CEA

CEA

Stent

Yadav et al, AHA 2002