Three-year results of SPIRIT III clinical trial reaffirms safety of PROMUS and TAXUS Express stents

Sep 22 2009

Boston Scientific Corporation (NYSE: BSX) today welcomed three-year results from the SPIRIT III clinical trial, which continue to reaffirm the proven long-term safety of the Company's portfolio of drug-eluting stents, including the first-generation TAXUS((R)) Express(2)(TM) Paclitaxel-Eluting Coronary Stent System and the XIENCE V(TM) (PROMUS((R))) Everolimus-Eluting Coronary Stent System. The results were presented at the Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in San Francisco by Gregg W. Stone, M.D., Professor of Medicine and the Director of Research and Education at the Center for Interventional Vascular Therapy at the Columbia University Medical Center/New York-Presbyterian Hospital, and Principal Investigator of the trial.

"We are very pleased that our first-generation TAXUS Express Stent continued to perform well against our PROMUS Stent in the SPIRIT III trial at three years," said Donald S. Baim, M.D., Chief Medical and Scientific Officer of Boston Scientific. "The strong outcomes among diabetic patients were particularly impressive."

The results demonstrated that the XIENCE V (PROMUS) and TAXUS Express Stents had comparable safety outcomes through three years, with equivalent rates of cardiac death (1.4% versus 1.6%,>

The three-year rate of Ischemia-Driven Target Lesion Revascularization (TLR) was lower for the XIENCE V (PROMUS) Stent as compared to the TAXUS Express Stent (5.4% versus 8.9%,>

The SPIRIT III results exhibited similar rates of safety and efficacy for the XIENCE V (PROMUS) and TAXUS Express Stents in diabetic patients, with TLR rates of 5.2% versus 4.8% and MACE rates of 10.3% versus 9.4%. The rate of TLR for TAXUS Express diabetic patients was 4.8 percent as compared to 10.5 percent in non-diabetic TAXUS Express patients.

"It is noteworthy that the rate of TLR - which was equivalent for PROMUS and TAXUS Express in diabetic patients - was actually lower in diabetic patients treated with TAXUS Express than in non-diabetics treated with TAXUS Express," added Dr. Baim.

The PROMUS Stent is a private-labeled XIENCE V Everolimus-Eluting Coronary Stent System manufactured by Abbott and distributed by Boston Scientific. SPIRIT III is sponsored by Abbott. TAXUS, TAXUS Express2, Express and PROMUS are trademarks of Boston Scientific Corporation or its affiliates. XIENCE is a trademark of Abbott Laboratories Group of Companies.

The safety and effectiveness of the TAXUS Express Stent has not been established in diabetic patients.