Boston Scientific Reports Two-year Follow-up Data From HORIZONS-AMI Trial

Boston Scientific has declared a two-year follow-up data from the HORIZONS-AMI trial. 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, as 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 a 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 at the 21st annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in San Francisco.

The company said that HORIZONS-AMI demonstrated that the TAXUS Express Stent reduced angiographic restenosis, compared to an 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% for patients treated with DES vs 11.6% for BMS (p<0.001), a reduction of 42%. The secondary efficacy endpoint of ischemia-driven target vessel revascularization (TVR) was 8.9% for DES vs 13.3% for BMS (p<0.001), a reduction of 34%.

The company claims that primary safety endpoint of adverse cardiac events (MACE) at two years was comparable among DES and BMS patients (11.0% vs 11.2%, respectively, p=0.90), 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% DES vs 1.8% BMS, p=0.04), ischemia-driven TLR was lower among DES patients (2.6% DES vs 4.7% BMS, p=0.006), and ischemia-driven TVR showed similar lower rates with DES compared to BMS (3.4% DES vs. 5.2% BMS, p=0.03).

Keith Dawkins, associate chief medical officer of Boston Scientific, said: “HORIZONS-AMI results continue to highlight the value of the TAXUS Express Stent in this important high-risk AMI patient population. 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.”