A randomized trial found that patients with diabetes and coronary artery disease who underwent PCI and received paclitaxel-eluting stents had a significantly higher 1-year rate of the primary outcome of target-vessel failure compared with patients who received everolimus-eluting stents.
After a year, target-vessel failure occurred in 5.6 percent of patients in the paclitaxel-eluting stent group compared with 2.9 percent of patients in the everolimus-eluting stent group.
Lead author Upendra Kaul, MD, of the Fortis Escorts Heart Institute in India, presented the findings on Oct. 14 in a late-breaking clinical trials session at the Transcatheter Cardiovascular Therapeutics scientific symposium in San Francisco.
Results of the TUXEDO-India trial were simultaneously published online in The New England Journal of Medicine.
The researchers defined target-vessel failure as a composite of cardiac death, target-vessel MI or ischemia-driven target-vessel revascularization.
Patients in the paclitaxel-eluting stent group also had higher rates of spontaneous MI, target-vessel revascularization and target-lesion revascularization.
Boston Scientific, the manufacturer of the Taxus Element paclitaxel-eluting stent, funded the study. Abbott Vascular provided the Xience Prime everolimus-eluting stent for this trial.
Kaul said angioplasty and stenting in patients with diabetes are associated with a high risk for re-stenosis and stent thrombosis. He added that drug-eluting stents have replaced bare-metal stents for diabetics.
“The study supports the current worldwide practice of using new-generation everolimus-eluting stents even in patients who require insulin for the management of their diabetes,” Kaul said. “This may have important implications.”
Between June 23, 2011, and March 12, 2014, the researchers randomized 1,830 patients with diabetes and symptomatic coronary artery disease or silent ischemia to receive a paclitaxel-eluting stent or everolimus-eluting stent.
At baseline, 53.2 percent of patients had acute coronary syndrome, 28.5 percent had chronic stable angina, 11.6 percent had post-ST-segment elevation MI and 6.7 percent had asymptomatic ischemia. Approximately 40 percent of patients in each group had insulin-requiring diabetes.
The paclitaxel-eluting stent group had fewer stents per patient and per lesion, a higher maximum stent diameter per lesion and a higher extent of stenosis.
At one year, major cardiac adverse events occurred in 5.9 percent of the paclitaxel-eluting stent group and 3.4 percent of the everolimus-eluting stent group; spontaneous MI occurred in 3.2 percent and 1.2 percent of patients, respectively; stent thrombosis occurred in 2.1 percent and 0.4 percent of patients, respectively; and the composite of cardiac death and or target-vessel MI occurred in 4.0 percent and 2.3 percent of patients, respectively.
“I think this trial finally, completely answers that even in this group, especially the insulin-requiring diabetics, [that everolimus-eluting stents are superior],” Kaul said.