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

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.

• Authors: 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 Moliterno, E Magnus Ohman, Keith Oldroyd, Gennaro Sardella, Samin K Sharma, Richard Shlofmitz, Giora Weisz, Bernhard Witzenbichler, Stuart Pocock, Roxana Mehran
• Journal: JACC. Cardiovascular interventions (JACC Cardiovasc Interv) Vol. 14 Issue 13 Pg. 1434-1446 (07 12 2021) ISSN: 1876-7605 [Electronic] United States
• PMID: 34238553 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Chemical References

• Platelet Aggregation Inhibitors
• Ticagrelor
• Aspirin

Topics

• Age Factors
• Aged
• Aspirin (adverse effects)
• Drug Therapy, Combination
• Humans
• Percutaneous Coronary Intervention
• Platelet Aggregation Inhibitors (adverse effects)
• Ticagrelor (adverse effects)
• Treatment Outcome