PROMUS, First-Generation TAXUS Express Stents Perform Strongly in SPIRIT III Trial
September 21, 2009 — Boston Scientific Corp. 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 Express(2) Paclitaxel-Eluting Coronary Stent System and the XIENCE V (PROMUS ) 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.
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 percent) and low and equivalent rates of stent thrombosis using the ARC (Academic Research Consortium) definite/probable definition (1.2 and 1.6 percent). No additional stent thromboses were reported between years two and three for either stent group.
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 percent), contributing to a benefit for XIENCE V (PROMUS) over the TAXUS Express Stent in the composite endpoints of major adverse cardiac events (MACE, a composite endpoint of cardiac death, myocardial infarction (MI) and TLR) (9.1 versus 15.7 percent) and target vessel failure (TVF, a composite endpoint of cardiac death, MI and ischemia-driven target vessel revascularization) (13.5 versus 19.2 percent).
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 percent and MACE rates of 10.3 percent versus 9.4 percent. The rate of TLR for TAXUS Express diabetic patients was 4.8 percent as compared to 10.5 percent in nondiabetic TAXUS Express patients.
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. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties.
For more information: www.bostonscientific.com