Angiolillo DJ, Cao D, Baber U, Sartori S, Zhang Z, Dangas G, Mehta S, Briguori C, Cohen DJ, Collier T, Dudek D, Escaned J, Gibson CM, Gil R, Huber K, Kaul U, Kornowski R, Krucoff MW, Kunadian V, Moliterno DJ, Ohman EM, Oldroyd K, Sardella G, Sharma SK, Shlofmitz R, Weisz G, Witzenbichler B, Pocock S, and Mehran R
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 (p interaction = 0.62) and key secondary (p interaction = 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., Competing Interests: Funding Support and Author Disclosures This work was supported by an investigator-initiated grant from AstraZeneca. Dr. Angiolillo has received consulting fees or honoraria from Abbott, Amgen, Aralez, AstraZeneca, Bayer, Biosensors, Boehringer Ingelheim, Bristol Myers Squibb, Chiesi, Daiichi-Sankyo, Eli Lilly, Haemonetics, Janssen, Merck, PhaseBio, PLx Pharma, Pfizer, Sanofi, and The Medicines Company; has participated in review activities for CeloNova and St. Jude Medical; has received institutional payments for grants from Amgen, AstraZeneca, Bayer, Biosensors, CeloNova, CSL Behring, Daiichi-Sankyo, Eisai, Eli Lilly, Gilead, Idorsia, Janssen, Matsutani Chemical Industry, Merck, Novartis, Osprey Medical, Renal Guard Solutions, and the Scott R. MacKenzie Foundation. Dr. Baber has received speaking honoraria from AstraZeneca and Boston Scientific. Dr. Dangas has received consulting fees and advisory board fees from AstraZeneca; has received consulting fees from Biosensors; and previously held stock in Medtronic. Dr. Mehta has received grant support from and serving on an executive committee and as site investigator for AstraZeneca. Dr. Cohen has received research grant support from Edwards Lifesciences, Medtronic, Boston Scientific, Abbott, Svelte, Corvia, and Ancora; has received consulting fees from Edwards Lifesciences, Medtronic, Boston Scientific, Abbott, Svelte, Corvia, and Ancora. Dr. Krucoff has received consulting fees or honoraria and research grants from Abbott Vascular, Biosensors, Boston Scientific, CeloNova, Medtronic, and OrbusNeich. Dr. Gibson has received research grant support from AstraZeneca. Dr. Moliterno has received grants from AstraZeneca, during the conduct of the study. Dr. Gibson has received grant support and consulting fees from Angel Medical, Bayer, CSL Behring, Janssen Pharmaceuticals, Johnson & Johnson, and Portola Pharmaceuticals; has received consulting fees from The Medicines Company, Eli Lilly, Gilead Sciences, Novo Nordisk, WebMD, UpToDate Cardiovascular Medicine, Amarin Pharma, Amgen, Boehringer Ingelheim, Chiesi, Merck, PharmaMar, Sanofi, Somahlution, Verreseon, Boston Scientific, Impact Bio, MedImmume, Medtelligence, MicroPort, PERT Consortium, and GE Healthcare; holds equity in nference; serves as chief executive officer of the Baim Institute; and has received grant support, paid to the Baim Institute, from Bristol Myers Squibb. Dr. Huber has received lecture fees from AstraZeneca and Bayer. Dr. Weisz has received grant support and advisory board fees from and holds equity in Corindus; has received advisory board fees from and holds equity in Filterlex; serves on an advisory board for and holds options in Trisol; and has received grant support from Abbott, Cardiovascular Systems Inc, and RenalGuard. Dr. Oldroyd has received grant support and lecture fees from AstraZeneca. Dr. Escaned has received consulting and lecture fees from Abbott, Philips, Boston Scientific, and Medtronic; and has received lecture fees from Abiomed, Terumo, and Biosensors. Dr. Sharma has received consulting fees or honoraria from Abbott Vascular, Boston Scientific, and Cardiovascular Systems. Dr. Mehran reports grants from Abbott Laboratories, AstraZeneca, Bayer, Beth Israel Deaconess, Bristol Myers Squibb, CSL Behring, Daiichi-Sankyo, Medtronic, Novartis Pharmaceuticals, OrbusNeich; has received personal fees from Abbott Laboratories, Boston Scientific, Medscape/WebMD, Siemens Medical Solutions, PLx Opco dba PLx Pharma, Roivant Sciences, Sanofi, Medtelligence (Janssen Scientific Affairs), and Janssen Scientific Affairs; has received other compensation from Abbott Laboratories, Abiomed, Bristol Myers Squibb, Claret Medical, Elixir Medical, The Medicines Company, Spectranetics/Philips/Volcano, and Watermark Research Partners; and has received nonfinancial support and other compensation from Regeneron Pharmaceuticals and Idorsia Pharmaceuticals. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)