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Randomized Controlled Trial
. 2025 Feb 8;11(1):66-74.
doi: 10.1093/ehjcvp/pvae080.

Impact of ticagrelor with or without aspirin on total and recurrent bleeding and ischaemic events after percutaneous coronary intervention: a sub-study of the TWILIGHT trial

Usman Baber  1 , Davide Cao  2   3 , Timothy Collier  4 , Samantha Sartori  2 , George Dangas  2 , Dominick J Angiolillo  5 , Birgit Vogel  2 , Vijay Kunadian  6   7 , Carlo Briguori  8 , David J Cohen  9   10 , Dariusz Dudek  11 , C Michael Gibson  12 , Robert Gil  13 , Kurt Huber  14   15 , Upendra Kaul  16 , Ran Kornowski  17 , Mitchell W Krucoff  18 , Shamir Mehta  19 , David J Moliterno  20 , E Magnus Ohman  18 , Javier Escaned  21 , Gennaro Sardella  22 , Samin K Sharma  2 , Richard Shlofmitz  10 , Giora Weisz  23 , Bernhard Witzenbichler  24 , P Gabriel Steg  25 , Stuart Pocock  4 , Roxana Mehran  2
Affiliations
Randomized Controlled Trial

Impact of ticagrelor with or without aspirin on total and recurrent bleeding and ischaemic events after percutaneous coronary intervention: a sub-study of the TWILIGHT trial

Usman Baber et al. Eur Heart J Cardiovasc Pharmacother. .

Abstract

Aims: In standard time-to-first event analysis, early aspirin discontinuation followed by ticagrelor monotherapy has been shown to reduce bleeding without increasing ischaemic complications compared with ticagrelor plus aspirin after percutaneous coronary intervention (PCI). We evaluated whether these treatment effects are preserved when recurrent events are considered.

Methods and results: In this TWILIGHT trial post-hoc analysis, we assessed the effects of ticagrelor monotherapy on the total number of events that occurred over the 12-month follow-up among 7119 high-risk patients randomized to aspirin or placebo in addition to ticagrelor at 3 months post-PCI if event-free and adherent to treatment. There were 391 patients with at least one Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding (primary endpoint). Of those, 28 (7.2%) had a recurrent event. The total number of BARC 2, 3, or 5 bleeding events was 148 in the ticagrelor monotherapy arm compared with 278 with ticagrelor plus aspirin arm (P < 0.001). Among 272 patients with at least one key secondary ischaemic endpoint (all-cause death, myocardial infarction, or stroke), 37 (13.6%) sustained a recurrent event. Total ischaemic events were similar (155 vs. 159) in the two groups.

Conclusion: Among selected high-risk patients who underwent PCI and completed 3 months of dual antiplatelet therapy followed by ticagrelor with or without aspirin, recurrent bleeding was less common than recurrent ischaemic events over 12 months. Analysis of total events indicates that ticagrelor monotherapy continues to be more effective than ticagrelor plus aspirin in reducing bleeding without a signal of ischaemic harm.

Keywords: Aspirin; Bleeding; PCI; Recurrent events; Thrombosis; Ticagrelor monotherapy.

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Conflict of interest statement

U.B. receiving honoraria from Amgen, Abbott, AstraZeneca and Boston Scientific; D.C. receiving honoraria from Terumo; G.D., receiving consulting fees and advisory board fees from AstraZeneca, consulting fees from Biosensors, and previously holding stock in Medtronic; D.J.A. declares that he has received consulting fees or honoraria from Abbott, Amgen, AstraZeneca, Bayer, Biosensors, Boehringer Ingelheim, Bristol Myers Squibb, Chiesi, Daiichi Sankyo, Eli Lilly, Haemonetics, Janssen, Merck, Novartis, PhaseBio, PLx Pharma Inc., Pfizer, Sanofi and Vectura; D.J.A. also declares that his institution has received research grants from Amgen, AstraZeneca, Bayer, Biosensors, CeloNova, CSL Behring, Daiichi-Sankyo, Eisai, Eli Lilly, Gilead, Idorsia, Janssen, Matsutani Chemical Industry Co., Merck, Novartis, and the Scott R. MacKenzie Foundation; D. J. C., receiving grant support, paid to his institution, and consulting fees from AstraZeneca, Medtronic, Abbott Vascular, and Boston Scientific; J. E., receiving consulting fees and lecture fees from Abbott, Philips, Boston Scientific, and Medtronic, and lecture fees from Abiomed, Terumo, and Biosensors; K. H., receiving lecture fees from AstraZeneca and Bayer; S. M., receiving grant support from and serving on an executive committee and as site investigator for AstraZeneca; E.M.O., receiving consulting fees from 3D Communications, ACI Clinical, Biotie, Cara Therapeutics, Cardinal Health, Faculty Connection, Imbria, Impulse Medical, Janssen Pharmaceuticals, Medscape, Milestone Pharmaceuticals, and XyloCor, grant support and consulting fees from Abiomed, and grant support from Chiesi and Portola; P. G. S., receiving grant support and fees for serving on a steering committee from Bayer/Janssen, grant support and lecture fees from Merck, grant support, fees for serving as cochair of trials, consulting fees, and lecture fees from Sanofi, grant support, fees for serving on an executive steering committee, and consulting fees from Amarin, consulting fees and lecture fees from Amgen, consulting fees, lecture fees, and fees for serving on a critical event committee from Bristol Myers Squibb, fees for serving on an executive steering committee from Boehringer Ingelheim, fees for serving on a critical event committee from Pfizer, fees for serving on a steering committee and consulting fees from Novartis, consulting fees from Regeneron, Eli Lilly, and Novo Nordisk, consulting fees and lecture fees from AstraZeneca, grant support, fees for serving as chair of a data monitoring committee, and fees for serving as chair of a registry from Servier, and fees for serving on a steering committee from Idorsia; C.M.G., receiving grant support and consulting fees from Angel Medical, Bayer, CSL Behring, Janssen Pharmaceuticals, Johnson & Johnson, and Portola Pharmaceuticals, 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 Corporation, Boston Scientific, Impact Bio, MedImmume, Medtelligence, MicroPort, PERT Consortium, and GE Healthcare, holding equity in inference, serving as chief executive officer of Baim Institute, and receiving grant support, paid to Baim Institute, from Bristol Myers Squibb and Astra Zeneca. R.M. reports institutional research grants from Abbott, Abiomed, Applied Therapeutics, Arena, AstraZeneca, Bayer, Biosensors, Boston Scientific, Bristol Myers Squibb, Cardiawave, CellAegis, CERC, Chiesi, Concept Medical, CSL Behring, DSI, Insel Gruppe AG, Medtronic, Novartis Pharmaceuticals, OrbusNeich, Philips, Transverse Medical, ZOLL; personal fees from ACC, Boston Scientific, California Institute for Regenerative Medicine (CIRM), Cine-Med Research, Janssen, WebMD, SCAI; consulting fees paid to the institution from Abbott, Abiomed, AM-Pharma, Alleviant Medical, Bayer, Beth Israel Deaconess, Cardiawave, CeloNova Biosciences, Chiesi, Concept Medical, DSI, Duke University, Idorsia Pharmaceuticals, Medtronic, Novartis, Philips; Equity < 1% in Applied Therapeutics, Elixir Medical, STEL, CONTROLRAD (spouse); Scientific Advisory Board for AMA, Biosensors (spouse). The other authors have nothing to disclose.

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