Ticagrelor alone vs.Ticagrelor plus aspirin following percutaneous coronary intervention in patients with non-ST-segment elevation acute coronary syndromes: TWILIGHT-ACS

Usman Baber, George Dangas, Dominick Joseph Angiolillo, David Joel Cohen, Samin Kumar Sharma, Johny Nicolas, Carlo Briguori, Jin Yu Cha, Timothy Collier, Dariusz Dudek, Vladimir Dzavik, Javier Escaned, Robert Gil, Paul Gurbel, Christian W. Hamm, Timothy Henry, Kurt Huber, Adnan Kastrati, Upendra Kaul, Ran KornowskiMitchell Krucoff, Vijay Kunadian, Steven Owen Marx, Shamir Mehta, David Moliterno, Erik Magnus Ohman, Keith Oldroyd, Gennaro Sardella, Samantha Sartori, Richard Shlofmitz, Philippe Gabriel Steg, Giora Weisz, Bernhard Witzenbichler, Ya Ling Han, Stuart Pocock, Charles Michael Gibson, Roxana Mehran

Research output: Contribution to journalArticlepeer-review

47 Scopus citations

Abstract

Aims: The aim of this study was to determine the effect of ticagrelor monotherapy on clinically relevant bleeding and major ischaemic events in relation to clinical presentation with and without non-ST elevation acute coronary syndromes (NSTE-ACS) among patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES). Methods and results: We conducted a pre-specified subgroup analysis of The Ticagrelor With Aspirin or Alone in High Risk Patients After Coronary Intervention (TWILIGHT) trial, which enrolled 9006 patients with high-risk features undergoing PCI with DES. After 3 months of dual antiplatelet therapy (DAPT) with ticagrelor plus aspirin, 7119 adherent and event-free patients were randomized in a double-blind manner to ticagrelor plus placebo versus ticagrelor plus aspirin for 12 months. The primary outcome was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding while the composite of all-cause death, myocardial infarction (MI), or stroke was the key secondary outcome. Among patients with NSTE-ACS (n = 4614), ticagrelor monotherapy reduced BARC 2, 3, or 5 bleeding by 53% [3.6% vs. 7.6%; hazard ratio (HR) 0.47; 95% confidence interval (CI) 0.36-0.61; P < 0.001) and in stable patients (n = 2503) by 24% (4.8% vs. 6.2%; HR 0.76; 95% CI 0.54-1.06; P = 0.11; nominal Pint = 0.03). Rates of all-cause death, MI, or stroke among those with (4.3% vs. 4.4%; HR 0.97; 95% CI 0.74-1.28; P = 0.84) and without (3.1% vs. 3.2%; HR 0.96; 95% CI 0.61-1.49; P = 0.85) NSTE-ACS were similar between treatment arms irrespective of clinical presentation (Pint = 0.96). Conclusion: Among patients with or without NSTE-ACS who have completed an initial 3-month course of DAPT following PCI with DES, ticagrelor monotherapy reduced clinically meaningful bleeding events without increasing ischaemic risk as compared with ticagrelor plus aspirin. The benefits of ticagrelor monotherapy with respect to bleeding events were more pronounced in patients with NSTE-ACS. Trial registration: Clinicaltrials.gov identifier: NCT02270242.

Original languageEnglish
Pages (from-to)3533-3545
Number of pages13
JournalEuropean Heart Journal
Volume41
Issue number37
DOIs
StatePublished - Oct 1 2020

Bibliographical note

Publisher Copyright:
© 2020 Published on behalf of the European Society of Cardiology. All rights reserved.

Keywords

  • Acute coronary syndrome
  • Bleeding
  • Ticagrelor

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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