- NEWS . 29 May 2020
Ticagrelor monotherapy vs ticagrelor plus aspirin in patients with diabetes mellitus undergoing PCI: the TWILIGHT study
Current standard of care for prevention of thrombotic complications in patients undergoing percutaneous coronary intervention (PCI) is dual antiplatelet therapy (DAPT) with ticagrelor and aspirin, which has exhibited a promising bleeding reduction in several investigations. The TWILIGHT (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention) was a randomized, placebo-controlled trial aimed at examining the effect of ticagrelor monotherapy versus ticagrelor plus aspirin among patients with diabetes mellitus (DM) undergoing PCI.
Stable patients treated with ticagrelor and aspirin for 3 months were randomized 1:1 in a double-blind fashion to aspirin or placebo for an additional 12 months with combination of open-label ticagrelor. Patients with DM (n=2,620) were characterized by more frequent comorbidities and a higher prevalence of multivessel disease. The incidence of Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding in the placebo cohort versus aspirin cohort was 4.5% and 6.7%, respectively (hazard ratio [HR], 0.65; 95% confidence interval [CI], 0.47–0.91; p=0.012). Compared with ticagrelor and aspirin, ticagrelor monotherapy was not associated with an increase in ischaemic events including all-cause death, myocardial infarction or stroke (5.9% vs 4.6%; HR, 0.77; 95% CI, 0.55–1.09; p=0.14). The DM status was found to be an insignificant factor in bleeding events among the overall population.
In conclusion, ticagrelor monotherapy was associated with reduced clinical bleeding risk compared with ticagrelor plus aspirin. The effect without any influence in ischaemic events was consistent among patients undergoing PCI regardless of their DM status.
Angiolillo DJ, et al. Ticagrelor with or without aspirin in high-risk patients with diabetes mellitus undergoing percutaneous coronary intervention. J Am Coll Cardiol 2020. doi: 10.1016/j.jacc.2020.03.008. [Epub ahead of print]