Abstract Body (Do not enter title and authors here): Background: Optimal dual antiplatelet therapy(DAPT) following percutaneous coronary intervention (PCI) in patients with diabetes and multivessel coronary arterydisease (MVD) remains uncertain. Both ticagrelor and prasugrel are potent P2Y12 inhibitors, but their comparative efficacy and safety in this high-risk population is not well established.
Methods: TUXEDO-2 is a prospective, multi-centre, open-label, 2 × 2 factorial, randomized controlled trial. Patients with diabetes mellitus and angiographically confirmed MVD were randomized 1:1 to either SupraflexCruz SES or Xience EES and to receive either ticagrelor or prasugrel (factorial design), each in combination with aspirin, as part of DAPT. The current analysis focuses on comparing clinical outcomes between the two P2Y12 inhibitors. The primary endpoint was a composite endpoint of death, MI,stroke, or major bleeding as defined by the Bleeding Academic Research Consortium (BARC) at one year. The trial follow-up is ongoing and the randomized groups are currently not unblinded (will be referred as Group A vs. B).
Results: Among the 1800 patients with diabetes randomized, the mean age was 60±10 with females constituted 29.41% and 26.59% in Group A and B respectively. Insulin requirement was observed in 22.53% in Group A and 25.92% in Group B. Acute coronary syndrome at presentation was reported in 79.5% and in 78.1% patients of Group A and Group B. Triple vessel disease was seen in 84.5% in Group A and 85% in Group B. The mean stent length in Group A was 27.96±9.94 mm and in Group B was 27.98±9.93 mm. The two groups were comparable across all baseline variables, with no statistically significant differences observed. Follow-up is ongoing.The primary endpoint results will be presented for the first time at AHA.
Conclusion: TUXEDO-2 will help address the question of whether there are differences in clinical outcomes between ticagrelor or prasugrel in patients with diabetes and MVD undergoing PCI using contemporary drug eluting stents.