• Upendra Kaul, Sripal Bangalore, Ashok Seth, Priyadarshini Arambam, Rajpal K Abhaychand, Tejas M Patel, Darshan Banker, Atul Abhyankar, Ajit S Mullasari, Sanjay Shah, Rajneesh Jain, Premchand R Kumar, C G Bahuleyan, and TUXEDO–India Investigators.
• From the Fortis Escorts Heart Institute (U.K., A.S., P.A.) and Dharma Vira Heart Centre, Sir Ganga Ram Hospital (R.J.), New Delhi, L.R.G. Naidu Cardiology Research Institute and Clinic, G. Kuppuswamy Naidu Memorial Hospital, Coimbatore (R.K.A.), SAL Hospital and Medical Institute (T.M.P.) and Apex Heart Institute (S.S.), Ahmedabad, Bankers Heart Institute, Vadodara (D.B.), Shree B.D. Mehta Mahavir Heart Institute, Surat (A.A.), Institute of Cardiovascular Diseases, the Madras Medical Mission, Chennai (A.S.M.), Krishna Institute of Medical Sciences, Secunderabad (P.R.K.), and the Ananthapuri Hospitals and Research Institute, Trivandrum (C.G.B.) - all in India; and New York University School of Medicine, New York (S.B.).
• N. Engl. J. Med. 2015 Oct 29;373(18):1709-19.

BackgroundThe choice of drug-eluting stent in the treatment of patients with diabetes mellitus and coronary artery disease who are undergoing percutaneous coronary intervention (PCI) has been debated. Previous studies comparing paclitaxel-eluting stents with stents eluting rapamycin (now called sirolimus) or its analogues (everolimus or zotarolimus) have produced contradictory results, ranging from equivalence between stent types to superiority of everolimus-eluting stents.MethodsWe randomly assigned 1830 patients with diabetes mellitus and coronary artery disease who were undergoing PCI to receive either a paclitaxel-eluting stent or an everolimus-eluting stent. We used a noninferiority trial design with a noninferiority margin of 4 percentage points for the upper boundary of the 95% confidence interval of the risk difference. The primary end point was target-vessel failure, which was defined as a composite of cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization at the 1-year follow-up.ResultsAt 1 year, paclitaxel-eluting stents did not meet the criterion for noninferiority to everolimus-eluting stents with respect to the primary end point (rate of target-vessel failure, 5.6% vs. 2.9%; risk difference, 2.7 percentage points [95% confidence interval, 0.8 to 4.5]; relative risk, 1.89 [95% confidence interval, 1.20 to 2.99]; P=0.38 for noninferiority). There was a significantly higher 1-year rate in the paclitaxel-eluting stent group than in the everolimus-eluting stent group of target-vessel failure (P=0.005), spontaneous myocardial infarction (3.2% vs. 1.2%, P=0.004), stent thrombosis (2.1% vs. 0.4%, P=0.002), target-vessel revascularization (3.4% vs. 1.2%, P=0.002), and target-lesion revascularization (3.4% vs. 1.2%, P=0.002).ConclusionsIn 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 1 year. (Funded by Boston Scientific; TUXEDO-India Clinical Trials Registry-India number, CTRI/2011/06/001830).

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