Clinical trial comparing Boston Scientific's coronary stent systems

Sep 24 2009

Boston Scientific Corporation (NYSE: BSX) today welcomed one-year data from the SPIRIT IV clinical trial comparing the XIENCE V((R)) (PROMUS((R))) Everolimus-Eluting Coronary Stent System to the TAXUS((R)) Express2(TM) Paclitaxel-Eluting Coronary Stent System. The results support the benefits of paclitaxel-eluting stents in diabetic patients. The trial enrolled 3,690 patients, including 1,140 diabetics, the largest diabetic subset ever studied in a drug-eluting stent clinical trial.

The Company also announced that on October 1 it will begin its previously planned, phased discontinuation of the TAXUS Express Stent used in the SPIRIT IV trial. The TAXUS Express Stent has been replaced by the thinner-strut TAXUS((R)) Liberte((R)) Stent worldwide. The TAXUS Liberte Stent was approved in Europe in 2005, in the U.S. in 2008 and in Japan in 2009.

The SPIRIT IV results were presented at the 21(st) annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium 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 welcome the positive SPIRIT IV results reaffirming the safety and efficacy of our two drug-eluting stent platforms," said Donald S. Baim, M.D., Chief Medical and Scientific Officer at Boston Scientific. "The strong outcomes among diabetic patients treated with TAXUS Express were impressive, particularly the rates of target lesion failure (TLF) at one year, which were equivalent for PROMUS and TAXUS Express. These rates were actually lower for TAXUS Express in diabetic patients requiring insulin."

The TLF rates for diabetic patients at one year were 6.4% for the XIENCE V (PROMUS) Stent and 6.9% for the TAXUS Express Stent>

SPIRIT IV is a prospective, single-blinded, multicenter clinical trial in which patients with up to three native coronary artery lesions were randomized 2:1 to the XIENCE V (PROMUS) Stent or the TAXUS Express Stent at 66 U.S. sites. The primary endpoint is the rate of ischemia-driven TLF at one year, which is a composite measure of safety and efficacy consisting of cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization (TLR).

The results showed the trial met its endpoint of TLF non-inferiority with rates of 4.2% for the XIENCE V (PROMUS) Stent and 6.8% for the TAXUS Express Stent (p<0.0001). Contributing to this result was a significant difference in TLR (2.5% for XIENCE V (PROMUS) versus 4.6% for TAXUS Express, p<0.001), including a large subgroup of patients>

SPIRIT IV safety results demonstrated comparable rates of death (1.0% for XIENCE V (PROMUS) versus 1.3% for TAXUS Express,>

"We are pleased that our thinner-strut TAXUS Liberte Stent has proved so appealing to clinicians as a replacement for the TAXUS Express Stent," said Hank Kucheman, Senior Vice President and Group President, Cardiovascular for Boston Scientific. "We continue to be the only manufacturer offering both everolimus- and paclitaxel-based drug-eluting stent platforms, and we look forward to introducing our upcoming family of platinum chromium Element(TM) Stents, which will be offered in everolimus, paclitaxel and bare-metal versions."

The TAXUS stent systems -- both Liberte and Express -- have been evaluated by the industry's most extensive randomized, controlled clinical trial program, with follow-up to five years in some cases. These trial results have been supplemented by data on more than 50,000 patients enrolled in post-approval registries. To date, approximately 4.6 million TAXUS stents have been implanted globally, making them the world's most frequently used drug-eluting stents.

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

The TAXUS Liberte Stent has received an indication for use in diabetic patients in CE-Marked countries. In the United States, the TAXUS Express, TAXUS Liberte and PROMUS Stents are not specifically indicated for use in diabetic patients.