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Drug-eluting stents more effective, equally as safe as bare metal stents in clinical trial

October 16, 2008

Late-breaking data from the HORIZONS AMI (Harmonizing Outcomes with RevascularIZatiON and Stents in Acute Myocardial Infarction) trial reveal that after one year, use of a drug-eluting (paclitaxel) stent demonstrated significantly reduced rates of target lesion revascularization (TLR) and binary angiographic restenosis when compared to the use of a bare metal stent in heart attack patients. The results of the trial were presented at the 20th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation (CRF).

The primary safety measure of major adverse cardiovascular events (MACE), including death, reinfarction, stent thrombosis and stroke established the non-inferiority of drug-eluting stents with respect to safety through 1 year.

In the trial, the implantation of the drug-eluting stent resulted in a significant 41% reduction of ischemia-driven target lesion revascularization (TLR). TLR refers to the rate at which a particular lesion needs to be revascularized following angioplasty and was the primary efficacy endpoint of the trial.

Use of the drug-eluting stent also resulted in a significant 56% reduction in binary restenosis after 13 months, which is the rate at which the artery narrows following implantation of the stent, and was the secondary efficacy endpoint of the trial. The drug-eluting stent had a rate of 10.0% and the bare metal stent had a rate of 22.9%.

"These results provide definitive evidence that drug-eluting stents are superior in efficacy to bare metal stents and have a comparable safety profile at 1 year," said Gregg W. Stone, M.D., CRF Chairman, Professor of Medicine and the Director of Research and Education at the Center for Interventional Vascular Therapy at NewYork Presbyterian-Hospital/Columbia University Medical Center. Dr. Stone is the principal investigator of the HORIZONS AMI trial, which was sponsored by the Cardiovascular Research Foundation with research grant support from Boston Scientific Corporation and The Medicines Company.

"Outcomes from prior registry studies of drug-eluting stents compared to bare metal stents have been conflicting; this is the first prospective, large, international randomized clinical trial and provides conclusive evidence on this subject," said Dr. Stone. "The findings from the HORIZONS AMI trial will have a major impact on how decisions are made regarding drug-eluting and bare metal stents in the highest risk patients, those in the early hours of a heart attack. This study removes much of the uncertainty and concern about the efficacy and safety of drug-eluting stents in this clinical setting. Moreover, all of the patients in this trial will be followed for 5 years to ensure that these favorable results are maintained."

The HORIZONS AMI trial enrolled approximately 3,600 heart attack patients in 11 countries, 3,006 of whom were randomized to paclitaxel-eluting TAXUS stents versus otherwise identical bare metal stents. More than 120 national and international interventional cardiology centers participated in the trial.

Cardiovascular Research Foundation