HORIZONS-AMI Trial Shows Superior Outcomes for DES Over Bare Metal Stents


September 28, 2010

September 28, 2010 – Three-year follow-up data from the HORIZONS-AMI trial presented at Transcatheter Cardiovascular Therapeutics (TCT) 2010 last week continues to show marked improvement of paclitaxel-eluting stents over bare metal stents in acute myocardial infarction (AMI).

The trial, sponsored by the Cardiovascular Research Foundation (CRF) with grant support from Boston Scientific and The Medicines Company 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), or heart attack. With 3,006 patients enrolled worldwide, HORIZONS-AMI is the largest randomized trial to compare the use of drug-eluting stents to bare-metal stents for AMI patients.

Analysis of the data was presented 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, at CRF's annual TCT scientific symposium in Washington, D.C.

"Follow-up data from the HORIZONS-AMI trial continue to show that, in patients with AMI, paclitaxel-eluting stents were superior in efficacy to bare-metal stents and had a comparable safety profile," Stone said. "Significant reductions in measures of re-intervention at three years were observed with no evidence of late catch-up."

HORIZONS-AMI demonstrated that the Taxus Express stent significantly reduced clinical and angiographic restenosis compared to an otherwise identical bare metal Express control stent. After three years follow-up, the primary efficacy endpoint of ischemia-driven target lesion revascularization (TLR) was 9.4 percent for patients treated with Taxus Express vs. 15.1 percent for bare-metal Express (p<0.001), a relative reduction of 40 percent. The secondary efficacy endpoint of ischemia-driven target vessel revascularization (TVR) was 12.4 percent for Taxus Express vs. 17.6 percent for bare-metal Express (p<0.001), a relative reduction of 32 percent.

The primary safety endpoint of major adverse cardiac events (MACE) at three years was comparable for Taxus Express and bare-metal Express patients (13.6 vs. 12.9 percent, respectively, p=0.66), which is consistent with findings at one and two years. Individual rates of death, repeat heart attack, stroke and stent thrombosis between the two groups through three years of follow-up were also comparable.

The Taxus Express Stent and the Express Stent are not specifically indicated by the U.S. Food and Drug Administration (FDA) for use in patients with AMI.

For more information: www.bostonscientific.com