Drug-eluting stents are efficient and safe on heart attack patients undergoing angioplasty.
Lead researcher Dr. Gregg W. Stone, a professor of medicine at Columbia University Medical Center/New York-Presbyterian Hospital, has revealed that in patients undergoing angioplasty, the use of paclitaxel-eluting stents has been found to reduce rates of target lesion revascularization (TLR) and binary angiographic restenosis when compared to the use of bare-metal stents after 1 year.
The study also revealed that 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.
The trial enrolled 3,602 heart attack patients at 123 centers in 11 countries, 3,006 of whom were randomised to paclitaxel-eluting stents versus otherwise identical bare metal stents.
During the trial, the use of paclitaxel-eluting stents resulted in a significant reduction of ischemia-driven target-lesion revascularization (TLR)-the rate at which a particular lesion re-narrows following stent implantation severely enough to require either a repeat angioplasty or bypass surgery operation-at 12 months.
The use of paclitaxel-eluting stents also resulted in a significant reduction in binary restenosis after 13 months, which is the rate at which the artery re-narrows at least 50 per cent following implantation of the stent, and was the secondary efficacy endpoint of the trial. The paclitaxel-eluting stent had a rate of 10 per cent and the bare metal stent had a rate of 22.9 per cent.
"Outcomes from prior registry and randomised trials of drug-eluting stents compared to bare metal stents in heart attack patients have been conflicting. These 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 researchers believe that the findings of their study 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," said Dr. Stone.
A research article on the trial has been published in The New England Journal of Medicine.