|New studies continue to question value of DES vs. BMS. Image Source: Sarasota Memorial Hospital|
Patients receiving drug-eluting stents (DES), as part of an angioplasty, had better outcomes one year later than patients with bare-metal stents (BMS), according to a prospective study published as an early release Dec. 18 in the Canadian Medical Association Journal.
DES now comprises “at least 85 percent of stents used in the U.S. and up to 40 percent or more of stents elsewhere. The overwhelming worldwide use of drug-eluting stents has, however, been tempered by the cost differential to BMS,” the authors wrote.
The researchers found that mortality in the first 30 days for people with DES was significantly lower than for those with BMS. However, in this cohort study of 6,440 patients between April 1, 2003, and March 31, 2006, there was an increased risk of repeat revascularization procedures or death in the DES group after three years.
DES were inserted in 1,120 patients and BMS in 5,320. DES were selected for patients who had a greater burden of co-morbid illness, including diabetes mellitus (32.8 vs. 20.8 percent in the BMS group) and renal disease (7.4 vs. 5 percent).
“Our study findings suggest that drug-eluting stents, despite recent concerns surrounding drug-eluting stent safety, the long-term survival (to three years) of patients receiving drug-eluting stents remains globally favorable, and certainly not measurably worse than that of patients treated with bare metal stents," stated William Ghali, MD, co-author from the University of Calgary.
At one-year follow-up, the researchers found that DES was associated with a mortality of 3 percent as compared with 3.7 percent with the BMS. The rate of the composite outcome of death or repeat revascularization was 12 percent for the DES and 15.8 percent for the BMS.
During the three years of observation, they found that the relative risks for death and repeat revascularization varied over time. “We did observe a concerning risk trend toward accelerating adverse events in the DES group late in the follow-up period—a finding that underlines the need for ongoing surveillance of longer-term outcomes,” the authors wrote.
Philippe Généreux, MD and Roxana Mehran, MD, both from the Columbia University Medical Center in New York City, wrote in accompanying commentary that “despite the large amount of favorable long-term data on the use of drug-eluting stents from randomized controlled trials, meta-analyses and observational studies, the long-term safety of drug-eluting stents, especially regarding late and very late stent thrombosis, remains a major concern.”