Paclitaxel-eluting stents proved better than bare metal stents in preventing re-blocking of blood vessels, finds a large US trial.
Drug-eluting stents are more effective than bare-metal stents used in cardiovascular agioplasty, according to a new study published in The New England Journal of Medicine.
The US study showed that the use of paclitaxel-eluting stents reduced the rates of target lesion revascularization and binary angiographic restenosis (factors that lead to reblockage of blood vessels) in heart attack patients undergoing angioplasty, when compared with the use of bare metal stents after one year.
The study, called HORIZONS-AMI (Harmonizing Outcomes with RevascularIZatiON and Stents in Acute Myocardial Infarction), is the largest randomized comparison of drug-eluting and bare metal stents ever conducted, was performed by the Cardiovascular Research Foundation.
The open-label, multi-center, controlled study, enrolled 3,602 heart attack patients at 123 centers in 11 countries, 3,006 of whom were randomized to paclitaxel-eluting stents versus otherwise identical bare metal stents.
The use of paclitaxel-eluting stents resulted in a significant reduction of ischemia-driven target-lesion revascularization (TLR) at 12 months (4.5% vs. 7.5%), the study found.
TLR refers to the rate at which a particular lesion re-narrows following stent implantation severely enough to require either a repeat angioplasty or bypass surgery operation.
The study also compared 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.
Paclitaxel-eluting stents also reduced binary restenosis after 13 months. Binary restenosis is the rate at which the artery re-narrows at least 50% following implantation of the stent. The paclitaxel-eluting stent had a rate of 10.0% and the bare metal stent had a rate of 22.9%.
“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 long-term to ensure that these favorable results are maintained,” commented Gregg W. Stone, MD, of the Cardiovascular Research Foundation and professor of medicine at Columbia University Medical Center/New York-Presbyterian Hospital,who led the study.
Earlier studies, that attempted to compare outcomes from drug-eluting stents and bare metal stents in heart attack patients have been conflicting. In this context, these new results now provide definitive evidence that paclitaxel-eluting stents are superior in efficacy to bare metal stents and have a comparable safety profile at 1 year, said Dr. Stone.
The trail was sponsored and managed by the Cardiovascular Research Foundation with research grant support from Boston Scientific Corporation and The Medicines Company.
Started in 1990, the Cardiovascular Research Foundation (CRF) is an independent, academically focused nonprofit organization dedicated to improving the survival and quality of life for people with cardiovascular disease through research and education.
Columbia University Medical Center provides international leadership in basic, pre-clinical and clinical research, in medical and health sciences education, and in patient care. Established in 1767, Columbia University Medical Center is home to the largest medical research enterprise in New York City and state and one of the largest in the United States.