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

Usman Baber, Yangsoo Jang, Angelo Oliva, Davide Cao, Birgit Vogel, George Dangas, Samantha Sartori, Alessandro Spirito, Kenneth F. Smith, Mattia Branca, Timothy Collier, Stuart Pocock, Marco Valgimigli, Byeong Keuk Kim, Myeong Ki Hong, Roxana Mehran

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

Abstract

BACKGROUND: Dual antiplatelet therapy with a potent P2Y12inhibitor 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 P2Y12inhibitor 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.

Original languageEnglish
Pages (from-to)574-584
Number of pages11
JournalCirculation
Volume149
Issue number8
DOIs
StatePublished - 20 Feb 2024

Keywords

  • acute coronary syndrome
  • hemorrhage
  • percutaneous coronary intervention
  • purinergic P2Y receptor antagonists
  • ticagrelor

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