Friday, Boston Scientific Corp. (BSX) revealed its two-year follow-up data from the Horizons-AMI trial. The trial is aimed at measuring 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, or heart attack.
A total of 3,006 patients were enrolled for the study 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 at the twenty first annual Transcatheter Cardiovascular Therapeutics scientific symposium in San Francisco held on September 25.
The Natick, Massachusetts-based Boston Scientific said that the results of the two year-old study showed sustained efficacy benefits for patients treated with Taxus Express Stents, compared to bare-metal stents in patients with Horizons-AMI.
The data showed comparable safety outcomes for the Taxus Express and bare-metal stents. The 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 that the Taxus Express Stent 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 was 6.8% for patients treated with DES versus 11.6% for BMS, a reduction of 42%. The secondary efficacy endpoint of ischemia-driven target vessel revascularization was 8.9% for DES, compared to 13.3% for BMS, a reduction of 34%.
The primary safety endpoint of major adverse cardiac events at two years was comparable among DES and BMS patients, representing 11.0% and 11.2%, respectively, 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 ischemia-driven TLR was lower among DES patients, and ischemia-driven TVR showed similar lower rates with DES compared to BMS.
Commenting on the data, Boston Scientific's associate chief medical officer Keith Dawkins said, "The reductions in TLR, TVR and mortality with DES compared to BMS between one and two years suggest improving safety measures that warrant further investigation. We are proud to support this and other large clinical trials that provide the medical community data that can be used in combination with broader clinical judgment to develop optimal treatment strategies for challenging patient subsets."
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.
BSX closed Friday's regular trading at $10.35, down $0.28 or 2.63% on a volume of 22.59 million shares.
MDCO closed Friday's regular trading at $11.34, down $0.20 or 1.73% on a volume of 457,328 shares. Further, the stock lost $0.04 or 0.35% in the after hours.
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