The following is the summary of “Rationale and design of the TUXEDO-2 India study: Ultra-Thin strUt Supraflex Cruz versus XiencE in a Diabetic Population with multi-vessel disease–2” published in the February 2023 issue of Heart Journal by Kaul, et al.
Results from the FREEDOM trail, which demonstrated the superiority of coronary artery bypass graft(CABG) over first-generation drug-eluting stents (DES), including a reduction in mortality, cast doubt on the role of percutaneous coronary interventions (PCI) in patients with diabetes mellitus and multi-vessel disease. Those 2012 results need to be reevaluated in light of safer and more effective stents and much better medical treatment. The purpose of the TUXEDO-2 trial is to evaluate and contrast 2 additional stents in Indian patients with diabetes and multi-vessel disease. Study TUXEDO-2’s major goal is to evaluate the efficacy of ultra-thin Supraflex Cruz against Xience PCI in conjunction with modern optimal medical therapy (OMT) for diabetic patients with multi-vessel disease.
The secondary aim is to evaluate clinical outcomes between CABG and PCI using a performance target derived from the CABG arm of the FREEDOM trial in a pooled cohort from both arms of the study (Supraflex Cruz + Xience; PCI arm) (historical cohort). The secondary goal is to determine if ticagrelor or prasugrel is more effective than aspirin in preventing ischemia and bleeding events combined. About 1,800 patients with diabetes mellitus and multi-vessel disease (inclusion criteria similar to FREEDOM trial) with an indication for coronary revascularization will be randomly assigned to receive either Supraflex Cruz or Xience stents and either ticagrelor or prasugrel based antiplatelet strategies in this prospective, open-label, multi-centre, 2 2 factorials, randomized, controlled study. OMT and optimum PCI, including image- and physiology-guided full revascularization, will be administered to all patients in accordance with established guidelines. To determine the patients’ current health and any notable changes, they will be monitored for five years. With an estimated event rate of 11% and a non-inferiority margin of 4.5%, the primary outcome is a comparison of the success rate of Supraflex Cruz and Xience in preventing target lesion failure after one year. The primary endpoint for PCI vs. CABG is the composite of all-cause mortality, nonfatal myocardial infarction, and stroke at one year and annually up to 5 years (the secondary aim), with a performance goal of 21.6%.
At 1 year, the primary endpoint for comparing ticagrelor and prasugrel (tertiary objective) is a composite of death, myocardial infarction, stroke, and major bleeding, according to the Bleeding Academic Research Consortium (BARC), with an expected event rate of 15% and a non-inferiority margin of 5%. Modern, state-of-the-art PCI combined with guideline-directed OMT was tested in the TUXEDO-2 research, which analyzed a diverse group of patients with diabetes mellitus and multiple vascular diseases. The trial will determine if the ultra-thin, biodegradable Supraflex Cruz stent with a polymer coating is viable for percutaneous coronary intervention in diabetic individuals with multi-vessel disease. It will also shed light on the intriguing possibility of how the FREEDOM trial’s findings would have changed if conducted today, with today’s safer and more effective stents and cutting-edge medical care. In addition, both ticagrelor and prasugrel will be tested with aspirin to see which one is more effective and which one is safer.