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

Colombo's Tips & Tricks for Drug Eluting Stents
by Antonio Colombo (Author), Goran Stankovic (Author)

A trailblazer in interventional cardiology, Dr. Antonio Colombo combines his vast experience with that of Goran Stankovic and distinguished colleagues to share tips and tricks for dealing with diseased coronary arteries. Whether discussing his 'crushing and kissing' techniques or the stenting of tortuous vessels in the elderly, Dr. Colombo and his colleagues' texts and case commentaries provide the reader with succinct and simple advice based on personal experience. They provide the most comprehensive and practical guide available for those involved in coronary artery stenting. The images are all down-loadable in Powerpoint and will be of tremendous use to instructors and students alike.

Handbook of Drug-Eluting Stents
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Handbook of Drug-Eluting Stents, under the editorial direction of Patrick Serruys, one of the world's leading interventional cardiologists, and Tony Gershlick, a pioneer in the field of drug-eluting stents, provides the reader with up-to-date information on which stents and pharmacological agents in use or about to be launched, the kinetics of the drugs involved, and what the future may hold.

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by Icon Group International (Author)

This econometric study covers the outlook for drug-eluting stents in Asia. For each year reported, estimates are given for the latent demand, or potential industry earnings (P.I.E.), for the country in question (in millions of U.S. dollars), the percent share the country is of the region and of the globe. These comparative benchmarks allow the reader to quickly gauge a country vis-a-vis others. Using econometric models which project fundamental economic dynamics within each country and across countries, latent demand estimates are created. This report does not discuss the specific players in the market serving the latent demand, nor specific details at the product level. The study also does not consider short-term cyclicalities that might affect realized sales. The study, therefore, is...

The 2009-2014 Outlook for Drug-Eluting Stents in Africa, Europe & the Middle East
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