Ticagrelor with or without Aspirin in High-Risk Patients with Diabetes Mellitus undergoing Percutaneous Coronary Intervention.

ABSTRACT Background P2Y12 inhibitor monotherapy with ticagrelor after a brief period of dual antiplatelet therapy can reduce bleeding without increasing ischemic harm after percutaneous coronary intervention (PCI). The impact of this approach among patients with diabetes mellitus (DM) remains unknown. Objectives To examine the effect of ticagrelor monotherapy versus ticagrelor plus aspirin among patients with DM undergoing PCI. Methods This was a pre-specified analysis of the DM cohort in the TWILIGHT trial. After 3 months of ticagrelor plus aspirin, patients were maintained on ticagrelor and randomized to aspirin or placebo for 1 year. The primary endpoint was Bleeding Academic Research Consortium (BARC) 2, 3 or 5 bleeding. The composite ischemic endpoint was all-cause death, myocardial infarction, or stroke. Results Patients with DM comprised 37% (n=2620) of the randomized cohort and were characterized by more frequent comorbidities and a higher prevalence of multivessel disease. The incidence of BARC 2, 3 or 5 bleeding was 4.5% and 6.7% among patients with DM randomized to ticagrelor plus placebo versus ticagrelor plus aspirin (HR 0.65; 95% CI 0.47-0.91; p=0.012). Ticagrelor monotherapy was not associated with an increase in ischemic events compared with ticagrelor plus aspirin (4.6% vs 5.9%; HR 0.77; 95% CI 0.55 to 1.09; p=0.14). In the overall trial population, there was no significant interaction between DM status and treatment group for the primary bleeding or ischemic endpoints. Conclusions Compared with ticagrelor plus aspirin, the effect of ticagrelor monotherapy in reducing the risk of clinically relevant bleeding without any increase in ischemic events was consistent among patients with or without DM undergoing PCI.