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

Usman Baber(Mount Sinai Hospital), George Dangas(Mount Sinai Hospital), Dominick J. Angiolillo(University of Florida Health), David J. Cohen(University of Missouri–Kansas City), Samin K. Sharma(Mount Sinai Hospital), Johny Nicolas(Mount Sinai Hospital), Carlo Briguori(Clinica Mediterranea), Jin Yu(Mount Sinai Hospital), Timothy Collier(University of London), Dariusz Dudek(Jagiellonian University), Vladimír Džavík(University Health Network), Javier Escaned(Instituto de Investigación Sanitaria del Hospital Clínico San Carlos), Robert Gil(Ministry of Interior and Administration), Paul A. Gurbel(Sinai Hospital), Christian W. Hamm(Kerckhoff Klinik), Timothy D. Henry(Christ Hospital), Kurt Huber(Wilhelminen Hospital), Adnan Kastrati(Deutsches Herzzentrum München), Upendra Kaul(Batra Hospital and Medical Research Centre), Ran Kornowski(Rabin Medical Center), Mitchell W. Krucoff(Clinical Research Institute), Vijay Kunadian(Newcastle upon Tyne Hospitals NHS Foundation Trust), Steven O. Marx(Columbia University Irving Medical Center), Shamir R. Mehta(Hamilton Health Sciences), David J. Moliterno(University of Kentucky), E. Magnus Ohman(Clinical Research Institute), Keith G. Oldroyd(Golden Jubilee National Hospital), Gennaro Sardella(Policlinico Umberto I), Samantha Sartori(Mount Sinai Hospital), Richard Shlofmitz(St. Francis Hospital), Philippe Gabríel Steg(Hôpital Bichat-Claude-Bernard), Giora Weisz(Montefiore Medical Center), Bernhard Witzenbichler(Helios Amper-Klinikum Dachau), Yaling Han, Stuart Pocock(University of London), C. Michael Gibson(Beth Israel Deaconess Medical Center), Roxana Mehran(Mount Sinai Hospital)
European Heart Journal
August 4, 2020
10.1093/eurheartj/ehaa670
Cited by 172Open Access
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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.

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