Paclitaxel-Eluting Not Noninferior to Everolimus-Eluting Stent
Findings in patients with diabetes mellitus and coronary artery disease undergoing PCI
THURSDAY, Oct. 15, 2015 (HealthDay News) -- Paclitaxel-eluting stents are not noninferior to everolimus-eluting stents for patients with diabetes mellitus and coronary artery disease undergoing percutaneous coronary intervention (PCI), according to a study published online Oct. 14 in the New England Journal of Medicine to coincide with the Transcatheter Cardiovascular Therapeutics meeting, held from Oct. 11 to 15 in San Francisco.
Upendra Kaul, M.D., from the Fortis Escorts Heart Institute in India, and colleagues randomized 1,830 patients with diabetes mellitus and coronary artery disease who were undergoing PCI to receive a paclitaxel-eluting stent or an everolimus-eluting stent in a noninferiority trial. The primary end point was target-vessel failure (composite of cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization) at one year follow-up.
The researchers found that compared with the everolimus-eluting stent group, the paclitaxel-eluting stent group did not meet the criterion for noninferiority with respect to the primary end point at one year (2.9 versus 5.6 percent; P = 0.38 for noninferiority). The one-year rates of target-vessel failure, spontaneous myocardial infarction, stent thrombosis, target-vessel revascularization, and target-lesion revascularization were significantly higher in the paclitaxel-eluting versus the everolimus-eluting stent group.
"In patients with diabetes mellitus and coronary artery disease undergoing PCI, paclitaxel-eluting stents were not shown to be noninferior to everolimus-eluting stents, and they resulted in higher rates of target-vessel failure, myocardial infarction, stent thrombosis, and target-vessel revascularization at one year," the authors write.
The study was funded by Boston Scientific.