|New one-year results for DES are assuaging previous concerns. Image Source: IP ADR Blog|
WASHINGTON—After one year, use of a drug-eluting stent (DES) in heart attack patients demonstrated significantly reduced rates of target lesion revascularization (TLR) and binary angiographic restenosis when compared to the use of a bare metal stent (BMS), according to the HORIZONS AMI trial presented Wednesday at the 20th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.
HORIZONS AMI [Harmonizing Outcomes with RevascularIZatiON and Stents in Acute MI] is the largest randomized trial to compare DES to BMS in MI patients with more than 120 global interventional cardiologist centers in the trial.
The researchers enrolled 3,602 patients with STEMI with symptom onset less than 12 hours in 11 countries. The patients were randomized either Boston Scientific’s Taxus paclitaxel DES (2,257) or Boston Scientific’s Express BMS.
The primary safety measure of major adverse cardiovascular events (MACE), including death, reinfarction, stent thrombosis and stroke established the non-inferiority of DES with respect to safety through one year.
In the trial, the implantation of the DES resulted in a significant 41 percent 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, said principal investigator Gregg W. Stone, MD, TCT co-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 in New York City.
He reported that the use of DES also resulted in a significant 56 percent 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. DES had a rate of 10 percent and BMS had a rate of 22.9 percent.
“These results provide definitive evidence that drug-eluting stents are superior in efficacy to bare metal stents and have a comparable safety profile at one year,” Stone said.
“Outcomes from prior registry studies of DES compared to BMS have been conflicting; this is the first prospective, large, international randomized clinical trial and provides conclusive evidence on this subject,” Stone said. “The findings from the HORIZONS AMI trial will have a major impact on how decisions are made regarding DES and BMS in the highest risk patients, those in the early hours of a heart attack. The study removes much of the uncertainty and concern about the efficacy and safety of DES in this clinical setting.”
Stone also said that all of the patients in the trial will be followed for five years.
The HORIZONS AMI trial was funded by the Cardiovascular Research Foundation, which sponsors TCT, as well as by research grant support from Boston Scientific and the Medicines Company.