Stenting and Angioplasty With Protection in Patients at High Risk for Endarterectomy (SAPPHIRE)

Completed

Phase 3 Results

Results

The primary end point occurred in 20 patients randomly assigned to undergo carotid-artery stenting (CAS) with an emboli-protection device (cumulative incidence, 12.2%) and in 32 patients randomly assigned to undergo carotid endarterectomy (CEA)(cumulative incidence, 20.1%, absolute difference, 7.9%; 95 percent confidence interval, 16.4 to 0.7 %; P=0.004 for noninferiority, and P=0.053 for superiority). At 36 months the incidence of stroke was virtually identical for both CAS and CEA (7.1% for CAS and 6.7% for CEA, P = 0.945), indicating that CAS is non-inferior to CEA. The 3-year incidence of stroke across the CAS treatment group members had only an average increase of 4.0% over the 30-day stroke rate.