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 The TAXUS Express Stent has been replaced by the thinner-strut TAXUS((R)) Liberte((R)) Stent worldwide.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,>