Public Release: 

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

Data presented at TCT 2005

Edelman Public Relations

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.

###

Cordis Endovascular, a division of Cordis Corporation, is a market leader in endovascular diagnostic catheters and a recognized leader in endovascular education, research and development. The company has the resources to develop and launch breakthrough treatments and a history of delivering reliable, quality products to customers and patients.

Cordis Corporation, a Johnson & Johnson company, is a worldwide leader in developing and manufacturing interventional vascular technology. Through the company's innovation, research and development, physicians worldwide are better able to treat the millions of patients who suffer from vascular disease. For more information about Cordis Corporation, visit http://www.Cordis.com

Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.