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Three-year SAPPHIRE and US carotid feasibility trials demonstrate durability of carotid stenting

October 18, 2005

Washington, D.C., October 18, 2005 ““ Preliminary three-year data from the SAPPHIRE and final three-year data from the U.S. Carotid Feasibility Study (USFS) presented at the 2005 Transcatheter Cardiovascular Therapeutics meeting, demonstrate the long-term durability of carotid artery stenting (CAS) for the prevention of stroke versus carotid endarterectomy (CEA) in high risk surgical patients.

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 ANGIOGUARDTM XP Emboli Capture Guidewire System maintained a low incidence of stroke after the first 30 days for the duration of the three-year follow-up in the USFS and SAPPHIRE. In the SAPPHIRE trial, 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). The 3-year incidence of stroke across the randomized and non-randomized CAS treatment groups in SAPPHIRE and the USFS had only an average increase of 4.0% over the 30-day stroke rate. Cordis Corporation, a Johnson & Johnson company, sponsored the SAPPHIRE and USFS clinical trials.

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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