Ultra-Thin Sirolimus-Eluting Versus Everolimus-Eluting Stents in Diabetic Multivessel Coronary Artery Disease Patients: The TUXEDO-2 Trial.
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Kaul Upendra, Sinha Santosh Kumar, Singh Rakendra, Parida Ashok Kumar, Mody Rohit, Abhaichand Rajpal, Banker Darshan, Khan Aziz, Kalyansundaram Arun, Moorthy Nagaraja, Sharma Rajesh, Chandra Sharad, Bordoloi Neil, Kumar Dilip, Chandra Koduganti Sarat, Gunasekaran Sengottuvelu, Kapoor Rajneesh, Baruah Rituparno, Mantri Raja Ram, Patil Ravikant, Sharma Yashpaul, Agrawal Deepesh Kumar, Ragava P V, Garg Rajeev, Reddy K M K, Chandra Praveen, Kumar Santosh, Arambam Priyadarshini, Khan Nagma, Sudhir Krishnankutty, Bangalore Sripal, TUXEDO- 2 India Investigators
Аннотация
OBJECTIVES: The purpose of this study was to compare the clinical outcomes of ultra-thin biodegradable polymer (BP) SES vs durable polymer (DP) EES when combined with contemporary optimal medical therapy in patients with diabetes and multivessel disease.
METHODS: The TUXEDO-2 is an investigator-initiated prospective, open-label, multicenter, 2 × 2 factorial, randomized (1:1) controlled trial. Patients undergoing percutaneous coronary intervention were randomized to receive either a Supraflex Cruz SES or Xience EES. The participants were also randomized to Ticagrelor or Prasugrel. The primary endpoint was target lesion failure, a composite of cardiac death, target vessel myocardial infarction or ischemia-driven target lesion revascularization at 1-year follow up. The trial was designed to test noninferiority of BP-SES vs DP-EES, with a noninferiority margin of 4.5% (1-sided upper 97.5% confidence bound).
RESULTS: Among the 1,800 patients randomized, mean age was 60.3 years with 28% of participants being women. At 1 year, the primary endpoint of target lesion failure occurred in 148 patients, including 70 patients (7.92%) in the BP-SES group and 78 patients (8.75%) in the DP-EES group. The risk difference of -0.83 percentage points (1-sided upper 97.5% confidence bound 3.42%) met the prespecified noninferiority margin (PNI = 0.005). There were no significant differences in cardiac death (3.6% vs 3.4%), target vessel myocardial infarction (6.61% vs 7.54%), and ischemia-driven target lesion revascularization (0.8% vs 1.0%) between the 2 groups. Nonfatal myocardial infarction (4.7% vs 6.4%) and stent thrombosis was similar (1.0 % vs 0.7%) between the 2 groups.
CONCLUSIONS: In patients with diabetes and multivessel disease undergoing percutaneous coronary intervention, ultra-thin biodegradable polymer SES was noninferior to durable polymer EES at 1 year follow-up. (Trial Registration Number CTRI/2019/11/022088).