Three hundred thirty-four patients in the SAPPHIRE trial were randomized to either CAS or CEA. Patients who received CAS with the PRECISE® Nitinol Self-Expanding Stent and ANGIOGUARD
Jay S. Yadav, M.D., the Cleveland Clinic Foundation, and a principal investigator for the SAPPHIRE trial said, "The SAPPHIRE trial demonstrated CAS was non-inferior to CEA. This is important new data which suggests the long-term durability of CAS in this patient population."
An analysis of target lesion revascularization (TLR) with follow up to three years in the randomized arms of SAPPHIRE showed reintervention rates of 3.0% for CAS and 7.1% for CEA, P = 0.084. Three-year TLR rates for CAS were similar in the USFS.
Additional Carotid Stenting Data
Data from the SAPPHIRE, USFS, and CASCADE clinical trials also were presented in two poster sessions highlighting CAS involving ANGIOGUARD. The data suggests emboli protection is effective in preventing major strokes during carotid stenting. 30-day stroke rates were 8.6% for the 266 patients treated with stenting alone and 2.6% for the 116 patients treated by stenting with ANGIOGUARD. In addition, no patients treated with an ANGIOGUARD in CASCADE, USFS or in the treated randomized portion of SAPPHIRE had a major stroke. Approximately two-thirds of the minor ipsilateral strokes that occurred in these trials resolved with time.
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