Three-Year HORIZONS-AMI Data Presented at TCT

September 25, 2010—Boston Scientific Corporation (Natick, MA) announced 3-year follow-up data from the HORIZONS-AMI trial, which 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 randomized HORIZONS-AMI trial has enrolled 3,006 patients worldwide.

Principal investigator Gregg W. Stone, MD, presented analysis of the data Transcatheter Cardiovascular Therapeutics scientific symposium in Washington, DC.

“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,” commented Dr. Stone. “Significant reductions in measures of reintervention at 3 years were observed with no evidence of late catch-up.”

According to Boston Scientific, HORIZONS-AMI demonstrated that the Taxus Express² stent significantly reduced clinical and angiographic restenosis compared to an otherwise identical bare-metal Express control stent. After 3 years of follow-up, the primary efficacy endpoint of ischemia-driven target lesion revascularization was 9.4% for patients treated with Taxus Express² versus 15.1% for bare-metal Express (P < .001), a relative reduction of 40%.

The secondary efficacy endpoint of ischemia-driven target vessel revascularization was 12.4% for Taxus Express² versus 17.6% for bare-metal Express (P < .001), a relative reduction of 32%.

The company noted that the primary safety endpoint of major adverse cardiac events at 3 years was comparable for Taxus Express² and bare-metal Express patients (13.6% vs 12.9%, respectively; P = .66), which is consistent with findings at 1 and 2 years. Individual rates of death, repeat heart attack, stroke, and stent thrombosis between the two groups through 3 years of follow-up were also comparable.

Boston Scientific advised that the Taxus Express² stent and the Express bare-metal stent are not specifically indicated by the US Food and Drug Administration for use in patients with AMI.