Drug-Eluting Stents Linked to Favorable Outcomes
True even in cases of 'off-label' use
TUESDAY, Feb. 5 (HealthDay News) -- Drug-eluting stents have more favorable outcomes than bare-metal stents, even in cases of "off-label" use, according to two studies published in the Feb. 12 issue of the Journal of the American College of Cardiology.
In the first study, Robert J. Applegate, M.D., and colleagues from Wake Forest University School of Medicine in Winston-Salem, N.C., compared clinical outcomes in 1,164 patients who received bare-metal stents and 1,285 patients who received drug-eluting stents (more than 75 percent for "off-label" indications). After two years, they found that drug-eluting stents were associated with a lower risk of non-fatal myocardial infarction and death, even for "off-label" stent procedures.
In the second study, Bas L. van der Hoeven, M.D., and colleagues from Leiden University Medical Center in the Netherlands randomly assigned 310 patients with ST-segment elevation myocardial infarction to bare-metal stents or sirolimus-eluting stents. They found that drug-eluting stents were associated with significantly higher event-free survival at 12 months as well as target-vessel-failure-free survival, while rates of death, myocardial infarction and stent thrombosis were similar.
"In summary, although additional trials are warranted, it appears that drug-eluting stents are safe and effective both for FDA-approved indications as well as for many off-label indications," Cindy L. Grines, M.D., from William Beaumont Hospital in Royal Oak, Mich., writes in an accompanying editorial. "Physicians seem to be using their best judgment to use off-label drug-eluting stents for lesions at high risk of restenosis, namely, small vessels, long lesions, in-stent restenosis, chronic occlusions or vein grafts."
The first study was partially supported by Cordis Corporation and Boston Scientific. The second study was partially supported by an unrestricted research grant from Guidant Inc.