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Randomized Controlled Trial
. 2025 May 16;21(10):550-559.
doi: 10.4244/EIJ-D-24-00973.

Ticagrelor monotherapy versus ticagrelor plus aspirin in patients with chronic coronary syndrome and high ischaemic risk: a post hoc analysis of the TWILIGHT trial

Mauro Gitto  1   2 , Usman Baber  3 , Samantha Sartori  1 , Birgit Vogel  1 , Dominick J Angiolillo  4 , Carlo Briguori  5 , David J Cohen  6   7 , Timothy Collier  8 , Dariusz Dudek  9 , Angelo Oliva  1   2 , Javier Escaned  10 , Yihan Feng  1 , C Michael Gibson  11 , Ya-Ling Han  12 , Francesca Maria Di Muro  1 , Richard A Shlofmitz  7 , Kurt Huber  13   14 , Philippe Gabriel Steg  15 , Samin Sharma  1 , Gennaro Sardella  16 , Adnan Kastrati  17 , Upendra Kaul  18 , Ran Kornowski  19 , Vijay Kunadian  20   21 , Giulio G Stefanini  22   2 , Shamir R Mehta  23 , George Dangas  1 , Roxana Mehran  1
Affiliations
Randomized Controlled Trial

Ticagrelor monotherapy versus ticagrelor plus aspirin in patients with chronic coronary syndrome and high ischaemic risk: a post hoc analysis of the TWILIGHT trial

Mauro Gitto et al. EuroIntervention. .

Abstract

Background: Short dual antiplatelet therapy (DAPT) followed by ticagrelor monotherapy may be a valuable therapeutic option for patients with chronic coronary syndrome (CCS) and high ischaemic risk (HIR) undergoing percutaneous coronary intervention (PCI).

Aims: We aimed to compare ticagrelor monotherapy with ticagrelor-based DAPT in CCS patients with and without HIR undergoing PCI.

Methods: The present analysis included the CCS cohort of the TWILIGHT trial, which randomised PCI patients to ticagrelor alone or in combination with aspirin for 12 months after 3 months of ticagrelor-based DAPT. Patients were stratified into HIR and non-HIR based on the 2019 European Society of Cardiology (ESC) CCS guidelines definition. Outcomes of interest were major adverse cardiac and cerebrovascular events (MACCE), a composite of death, myocardial infarction or stroke, and Bleeding Academic Research Consortium (BARC) Type 2-5 bleeding at 1 year.

Results: Of the 2,503 CCS patients who underwent randomisation, the ESC definition classified 1,264 (50.5%) as HIR and 1,239 (49.5%) as non-HIR. HIR patients displayed a higher risk of MACCE (3.9% vs 2.3%; p=0.015) and similar rates of BARC Type 2-5 bleeding (5.1% vs 5.7%; p=0.455) as compared to non-HIR patients. Ticagrelor monotherapy and ticagrelor-based DAPT were associated with similar risks of MACCE (HIR: 4.0% vs 3.8%, hazard ratio [HR] 1.06, 95% confidence interval [CI]: 0.60-1.85; non-HIR: 2.1% vs 2.6%, HR 0.80, 95% CI: 0.38-1.66, pinteraction=0.553) and bleeding (HIR: 4.7% vs 5.7%, HR 0.82, 95% CI: 0.50-1.33; non-HIR: 4.9% vs 6.7%, HR 0.71, 95% CI: 0.44-1.14; pinteraction=0.684) in both the HIR and non-HIR groups.

Conclusions: In a post hoc analysis of the TWILIGHT trial that included CCS patients undergoing PCI, ticagrelor monotherapy after 3 months of DAPT appeared to be safe and was not associated with increased risks of ischaemic or bleeding events, regardless of baseline HIR status, compared with standard ticagrelor-based DAPT. These findings suggest the potential to expand guideline recommendations for ticagrelor monotherapy in CCS.

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Conflict of interest statement

U. Baber has received honoraria from AstraZeneca and Boston Scientific. D.J. Angiolillo has received consulting fees or honoraria from Abbott, Amgen, AstraZeneca, Bayer, Biosensors, Boehringer Ingelheim, Bristol-Myers Squibb, Chiesi, CSL Behring, Daiichi Sankyo, Eli Lilly, Faraday, Haemonetics, Janssen, Merck, Novartis, Novo Nordisk, PhaseBio, PLx Pharma, Pfizer, Sanofi, and Vectura, outside the present work; and also declares that his institution has received research grants from Amgen, AstraZeneca, Bayer, Biosensors, CeloNova, CSL Behring, Daiichi Sankyo, Eisai, Eli Lilly, Faraday, Gilead, Janssen, Matsutani Chemical Industry Co., Merck, Novartis, Osprey Medical, RenalGuard Solutions, and the Scott R. MacKenzie Foundation. D.J. Cohen received research grant support (to institution) from Edwards Lifesciences, Abbott, Boston Scientific, Medtronic, CathWorks, Philips, Zoll Medical, and iRhythm; and consulting income from Edwards Lifesciences, Abbott, and Elixir Medical. J. Escaned has received consulting and lecture fees from Abbott, Philips, Boston Scientific, and Medtronic; and has received lecture fees from Abiomed, Terumo, and Biosensors. C.M. Gibson received research support from Johnson & Johnson and CSL Behring; he also receives consulting support from AstraZeneca, BMS, CSL Behring, Johnson & Johnson, Janssen, and Bayer. K. Huber has received lecture fees from AstraZeneca and Bayer. A. Kastrati is an inventor in a patent application related to drug-eluting stent technology; he also serves in the Data and Safety Monitoring Board of the TARGET IV trial sponsored by the Cardiovascular Research Foundation in New York, USA. R. Mehran reports institutional research payments from Abbott, Alleviant Medical, Beth Israel Deaconess Medical Center, Concept Medical, CPC Clinical Research, Cordis, Elixir Medical, Faraday Pharmaceuticals, Idorsia Pharmaceuticals, Janssen, MedAlliance, Mediasphere Medical, Medtronic, Novartis, Protembis GmbH, RM Global BioAccess Fund Management, and Sanofi US Services, Inc.; personal fees from Elixir Medical, IQVIA, Medtronic, Medscape/WebMD Global, and Novo Nordisk; has equity <1% in Elixir Medical, Stel, and ControlRad (spouse); and no fees from SCAI (Women in Innovations Committee Member), Faculty Cardiovascular Research Foundation (CRF), and Women as One (Founding Director); and honorarium from AMA - JAMA Cardiology (Associate Editor), and ACC (BOT Member, SC Member CTR Program). P.G. Steg received research grants from Amarin, Bayer, Sanofi, and Servier; and speaking or consulting fees from Amarin, Amgen, AstraZeneca, Bayer/Janssen, Bristol-Myers Squibb, Idorsia, MyoKardia, Novartis, Novo Nordisk, PhaseBio, Pfizer, Regeneron, Sanofi, and Servier. V. Kunadian has received personal fees/honoraria from Bayer, AstraZeneca, Abbott, Amgen, and Daiichi Sankyo. S.R. Mehta has received grant support from and has served on an executive committee and as site investigator for AstraZeneca. The other authors have no conflicts of interest to declare.

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