1. Safety and Efficacy of Ticagrelor Monotherapy in Patients With Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention: An Individual Patient Data Meta-Analysis of TWILIGHT and TICO Randomized Trials.
- Author
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Baber U, Jang Y, Oliva A, Cao D, Vogel B, Dangas G, Sartori S, Spirito A, Smith KF, Branca M, Collier T, Pocock S, Valgimigli M, Kim BK, Hong MK, and Mehran R
- Subjects
- Humans, Female, Middle Aged, Male, Ticagrelor adverse effects, Platelet Aggregation Inhibitors adverse effects, Drug Therapy, Combination, Randomized Controlled Trials as Topic, Aspirin adverse effects, Hemorrhage epidemiology, Biomarkers, Treatment Outcome, Acute Coronary Syndrome diagnosis, Acute Coronary Syndrome drug therapy, Acute Coronary Syndrome surgery, Percutaneous Coronary Intervention adverse effects, Myocardial Infarction therapy, Stroke epidemiology
- Abstract
Background: Dual antiplatelet therapy with a potent P2Y
12 inhibitor coupled with aspirin for 1 year is the recommended treatment for patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI). As an alternative, monotherapy with a P2Y12 inhibitor after a short period of dual antiplatelet therapy has emerged as a bleeding reduction strategy., Methods: We pooled individual patient data from randomized trials that included patients with ACS undergoing PCI treated with an initial 3-month course of dual antiplatelet therapy followed by ticagrelor monotherapy versus continued ticagrelor plus aspirin. Patients sustaining a major ischemic or bleeding event in the first 3 months after PCI were excluded from analysis. The primary outcome was Bleeding Academic Research Consortium type 3 or 5 bleeding occurring between 3 and 12 months after index PCI. The key secondary end point was the composite of death, myocardial infarction, or stroke. Hazard ratios and 95% CIs were generated using Cox regression with a one-stage approach in the intention-to-treat population., Results: The pooled cohort (n=7529) had a mean age of 62.8 years, 23.2% were female, and 55% presented with biomarker-positive ACS. Between 3 and 12 months, ticagrelor monotherapy significantly reduced Bleeding Academic Research Consortium 3 or 5 bleeding compared with ticagrelor plus aspirin (0.8% versus 2.1%; hazard ratio, 0.37 [95% CI, 0.24-0.56]; P <0.001). Rates of all-cause death, myocardial infarction, or stroke were not significantly different between groups (2.4% versus 2.7%; hazard ratio, 0.91 [95% CI, 0.68-1.21]; P =0.515). Findings were unchanged among patients presenting with biomarker-positive ACS., Conclusions: Among patients with ACS undergoing PCI who have completed a 3-month course of dual antiplatelet therapy, discontinuation of aspirin followed by ticagrelor monotherapy significantly reduced major bleeding without incremental ischemic risk compared with ticagrelor plus aspirin., Registration: URL: https://www.crd.york.ac.uk/prospero; Unique identifier: CRD42023449646., Competing Interests: Disclosures Dr Baber received honoraria/consulting fees from AstraZeneca, Amgen, Boston Scientific, and Abbott. Dr Mehran reports institutional research payments from Abbott, Abiomed, Affluent Medical, Alleviant Medical, Amgen, AM-Pharma, Applied Therapeutics, Arena, AstraZeneca, AtriCure Inc, Biosensors, Biotronik, Boston Scientific, Bristol Myers Squibb, CardiaWave, CeloNova, Chiesi, Concept Medical, CSL Behring, Cytosorbents, Daiichi Sankyo, Duke, Element Science, Faraday, Humacyte, Idorsia, I-Laser, Janssen, Magenta, MedAlliance, Medscape, Mediasphere, Medtelligence, Medtronic, MJH Healthcare, Novartis, OrbusNeich, Penumbra, PhaseBio, Philips, Pi-Cardia, PLx Pharma, Protembis, RenalPro, RM Global, Shockwave, Transverse Medical Inc, Vivasure, and Zoll; personal fees from Affluent Medical, Cardiovascular Research Foundation, Daiichi Sankyo Brasil, E.R. Squibb & Sons, Esperion Science/Innovative Biopharma, Europa Group/Boston Scientific, Gaffney Events, Educational Trust, Ionis Pharmaceuticals, J-CalC, Novartis, Novo Nordisk, Vectura, VoxMedia, IQVIA, McVeigh Global, Overcome, Primer Healthcare of New Jersey, Radcliffe, SL Solutions, TARSUS Cardiology, and WebMD; equity <1% in Applied Therapeutics, Elixir Medical, Stel, and ControlRad (spouse); participation in the scientific advisory board of the American Medical Association, the Women in Innovations Committee of the Society for Cardiovascular Angiography & Innovation, and the faculty of the Cardiovascular Research Foundation; and honoraria from JAMA Cardiology (associate editor) and the American College of Cardiology (board of trustees member; SC member, CTR Program). Dr Dangas has received consulting fees and advisory board fees from AstraZeneca; consulting fees from Biosensors; and previously held stock in Medtronic. Dr Cao has received consulting fees from Terumo. The other authors report no relationships relevant to the content of this article.- Published
- 2024
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