Ticagrelor With or Without Aspirin in High-Risk Patients With Diabetes Mellitus Undergoing Percutaneous Coronary Intervention

Dominick J. Angiolillo, Usman Baber, Samantha Sartori, Carlo Briguori, George Dangas, David J. Cohen, Shamir R. Mehta, C. Michael Gibson, Rishi Chandiramani, Kurt Huber, Ran Kornowski, Giora Weisz, Vijay Kunadian, Keith G. Oldroyd, Han Ya-Ling, Upendra Kaul, Bernhard Witzenbichler, Dariusz Dudek, Gennaro Sardella, Javier EscanedSamin Sharma, Richard A. Shlofmitz, Timothy Collier, Stuart Pocock, Roxana Mehran

Research output: Contribution to journalArticlepeer-review


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: The purpose of this study was 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 (Ticagrelor With Aspirin or Alone in High-Risk Patients after Coronary Intervention) 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 2, 3, or 5 bleeding. The composite ischemic endpoint was all-cause death, myocardial infarction, or stroke. Results: Patients with DM comprised 37% (n = 2,620) of the randomized cohort and were characterized by more frequent comorbidities and a higher prevalence of multivessel disease. The incidence of Bleeding Academic Research Consortium 2, 3, or 5 bleeding was 4.5% and 6.7% among patients with DM randomized to ticagrelor plus placebo versus ticagrelor plus aspirin (hazard ratio: 0.65; 95% confidence interval: 0.47 to 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%; hazard ratio: 0.77; 95% confidence interval: 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. (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention [TWILIGHT]; NCT02270242)

Original languageEnglish
Pages (from-to)2403-2413
Number of pages11
JournalJournal of the American College of Cardiology
Issue number19
StatePublished - 19 May 2020
Externally publishedYes


  • aspirin
  • bleeding
  • diabetes mellitus
  • thrombosis
  • ticagrelor monotherapy


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