SAN FRANCISCO – Everolimus-eluting stents were more effective than were paclitaxel-eluting stents in diabetes patients with coronary artery disease who underwent percutaneous coronary intervention (PCI) in the randomized, multicenter TUXEDO-India trial.
The everolimus-eluting stents were shown to be superior to paclitaxel-eluting stents on several endpoints, including target-vessel failure, myocardial infarction, and stent thrombosis at 1 year Dr. Upendra Kaul reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
Target vessel failure – the study’s primary endpoint, defined as a composite of cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization – occurred in 5.6% of 914 patients randomized to the paclitaxel-eluting stent group, compared with 2.9% of 916 randomized to the everolimus-eluting stent group (relative risk, 1.89), Dr. Kaul of Fortis Escorts Heart Institute, New Delhi, reported at the meeting, which was sponsored by the Cardiovascular Research Foundation.
The rate of spontaneous MI was 3.2% vs. 1.2% in the groups, respectively, and the rate of stent thrombosis was 2.1% vs. 0.4%. Target-vessel revascularization and target-lesion revascularization rates in both groups were 3.4% vs. 1.2% with paclitaxel- and everolimus-eluting stents, respectively, he said, noting that the superiority of everolimus-eluting stents was maintained in insulin-requiring patients.
The findings, which were published online simultaneously (N Engl J Med. 2015 Oct. 14;doi: 10.1056/NEJMoa1510188), effectively end the debate regarding whether paclitaxel-eluting stents are the better choice in diabetes patients with coronary artery disease.
Paclitaxel-eluting stents are generally accepted to be inferior to limus-eluting stents in most patients, but data from numerous trials have been conflicting as to whether that is true in diabetes patients.
“In the absence of a dedicated adequately powered study, a definitive answer is not possible,” Dr. Kaul said.
The findings from TUXEDO, the largest trial to compare paclitaxel- and everolimus-eluting stents head to head in diabetes patients, support “the current worldwide practice of use of new-generation limus-eluting stents, even in patients with insulin-requiring diabetes,” he said.
The findings raise questions about the results of prior coronary artery bypass grafting vs. stenting trials that show superiority of CABG, because first-generation stents, which are inferior to everolimus-eluting stents, were used as comparators in those trials, he noted.
Indeed, current guidelines for bypass surgery and PCI are based upon the findings of those trials, and while the TUXEDO findings don’t invalidate those prior studies, they do raise questions about whether the differences in favor of bypass surgery are much smaller than believed in the setting of modern stent use, commented Dr. Bernard J. Gersh of the Mayo Clinic, Rochester, Minn.
The TUXEDO-India trial was supported by Boston Scientific.