Impact of Age on the Safety and Efficacy of Ticagrelor Monotherapy in Patients Undergoing PCI

Dominick J. Angiolillo, Davide Cao, Usman Baber, Samantha Sartori, Zhongjie Zhang, George Dangas, Shamir Mehta, Carlo Briguori, David J. Cohen, Timothy Collier, Dariusz Dudek, Javier Escaned, C. Michael Gibson, Robert Gil, Kurt Huber, Upendra Kaul, Ran Kornowski, Mitchell W. Krucoff, Vijay Kunadian, David J. MoliternoE. Magnus Ohman, Keith Oldroyd, Gennaro Sardella, Samin K. Sharma, Richard Shlofmitz, Giora Weisz, Bernhard Witzenbichler, Stuart Pocock, Roxana Mehran

Research output: Contribution to journalArticlepeer-review

7 Scopus citations

Abstract

Objectives: The aim of this study was to assess the impact of age on the safety and efficacy of ticagrelor monotherapy after percutaneous coronary intervention (PCI). Background: As the risk for bleeding and ischemic complications after PCI increases with age, the authors conducted a pre-specified analysis of the TWILIGHT (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention) trial to evaluate the possible benefits of ticagrelor monotherapy according to age. Methods: The TWILIGHT trial enrolled patients undergoing PCI with drug-eluting stents who fulfilled at least 1 clinical and 1 angiographic high-risk criterion. Age ≥65 years was a clinical entry criterion. After 3 months of dual-antiplatelet therapy with ticagrelor, event-free patients were randomized to ticagrelor plus placebo or ticagrelor plus aspirin for an additional 12 months. The primary endpoint was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding. The key secondary endpoint was the composite of all-cause death, myocardial infarction, or stroke. Results: A total of 3,113 patients (47.7%) were ≥65 years of age. At 1 year after randomization, ticagrelor monotherapy significantly reduced BARC type 2, 3, or 5 bleeding (4.5% vs. 8.2%; hazard ratio: 0.53; 95% confidence interval: 0.40 to 0.71) without increasing ischemic events (4.2% vs. 4.4%; hazard ratio: 0.96; 95% confidence interval: 0.68 to 1.35) compared with ticagrelor plus aspirin among patients ≥65 years of age. These findings were consistent in patients <65 years of age with respect to the primary (pinteraction = 0.62) and key secondary (pinteraction = 0.77) endpoints and across different age categories. Conclusions: A strategy of ticagrelor monotherapy following 3 months of dual-antiplatelet therapy significantly reduced clinically relevant bleeding compared with ticagrelor plus aspirin without an increase in ischemic events, irrespective of age.

Original languageEnglish
Pages (from-to)1434-1446
Number of pages13
JournalJACC: Cardiovascular Interventions
Volume14
Issue number13
DOIs
StatePublished - 12 Jul 2021

Keywords

  • PCI
  • age
  • bleeding
  • thrombosis
  • ticagrelor monotherapy

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