There is as much as a four- to five-fold increased relative risk for late thrombosis, or blood clot formation, in patients with drug-eluting stents compared to those with bare-metal stents, according to a Cleveland Clinic-led meta-analysis appearing in the December issue of the American Journal of Medicine. This is the first published analysis of its kind.
Drug-eluting and bare-metal stents are commonly used to treat patients with coronary artery disease. There has been a growing body of evidence that drug-eluting stents, when compared to bare-metal stents, may increase the risk of blood clot formation long after they are implanted, potentially triggering a heart attack.
?Our analysis found there is a small, but real, hazard of late stent thrombosis with drug-eluting stents more so than with bare-metal stents, likely in the setting of discontinuation of anti-clotting drugs,? said Deepak L. Bhatt, M.D, Associate Director of the Cleveland Clinic Cardiovascular Coordinating Center and the study?s senior author. ?This does not, however, mean that drug-eluting stents should not be used, as other studies have shown that they do significantly reduce the need for repeat procedures compared with bare-metal stents.?
Fourteen studies with 6,675 total patients were included in the analysis comprising nine sirolimus stent trials and five paclitaxel stent trials. Eight of the trials reported more than a year of clinical follow-up. The sirolimus trials mandated anti-clotting medication for at least two to three months and the paclitaxel trials required six months.
?The key to the controversy is likely careful patient selection,? Dr. Bhatt said. ?Further research is needed to determine how best to utilize drug-eluting stents and anti-clotting medications.?
This analysis precedes an FDA Advisory Panel set to meet next week in Washington, D.C. The committee will discuss and make recommendations regarding issues related to stent thrombosis in coronary drug-eluting stents.
Cleveland Clinic Heart & Vascular Institute is the recognized world leader in diagnosis and treatment of cardiovascular disease. Cleveland Clinic has been ranked No. 1 in the nation for cardiac care by U.S. News & World Report every year since 1995. Cleveland Clinic has been ranked among America?s Ten Best Hospitals every year since 1990 by U.S. News & World Report.