September 29, 2009 – Boston Scientific Corp. Sept. 25 announced two-year follow-up data from the HORIZONS-AMI trial, is designed to determine the safety and efficacy of the TAXUS Express2 Paclitaxel-Eluting Coronary Stent System compared to bare-metal stenting in patients experiencing an acute myocardial infarction (AMI).
The trial is sponsored by the Cardiovascular Research Foundation (CRF) with grant support from Boston Scientific and The Medicines Company. With 3,006 patients enrolled worldwide, HORIZONS-AMI is the largest randomized trial to compare the use of drug-eluting stents (DES) to bare-metal stents (BMS) for AMI patients. Analysis of the data was presented today at the 21st annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in San Francisco.
"Results from the HORIZONS-AMI trial showed impressive and sustained efficacy benefits at two years for patients treated with TAXUS Express Stents when compared to bare-metal stents in patients with AMI," said 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 data also showed comparable safety outcomes for the TAXUS Express and bare-metal stents. This study should continue to inform how decisions are made regarding the use of drug-eluting stents in high-risk AMI patients during the early hours of a heart attack."
HORIZONS-AMI demonstrated the TAXUS Express significantly reduced angiographic restenosis compared to an otherwise identical bare-metal Express control stent. After two years follow-up, the primary efficacy endpoint of ischemia-driven target lesion revascularization (TLR) was 6.8 percent for patients treated with DES vs. 11.6 percent for BMS, a reduction of 42 percent. The secondary efficacy endpoint of ischemia-driven target vessel revascularization (TVR) was 8.9 percent for DES vs. 13.3 percent for BMS, a reduction of 34 percent.
The primary safety endpoint of major adverse cardiac events (MACE) at two years was comparable among DES and BMS patients (11 percent vs. 11.2 percent, respectively), which is consistent with one-year findings. Individual rates of death, repeat heart attack, stroke and stent thrombosis between the two groups through two years of follow-up were also comparable, even after correction for any measured baseline differences. Adverse events between one and two years showed that all-cause death was lower among DES patients (0.8 percent DES vs. 1.8 percent BMS), ischemia-driven TLR was lower among DES patients (2.6 percent DES vs. 4.7 percent BMS), and ischemia-driven TVR showed similar lower rates with DES compared to BMS (3.4 percent DES vs. 5.2 percent BMS).
The TAXUS Express Stent and the Express Stent are not specifically indicated by the U.S. Food and Drug Administration for use in patients with AMI.
For more information: www.bostonscientific.com