Background: In the TWILIGHT trial, ticagrelor monotherapy after a short course of dual antiplatelet therapy (DAPT) was shown to be a safe bleeding avoidance strategy in high-risk patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES). Aims: The aim of this study was to evaluate the effects of ticagrelor monotherapy after three-month DAPT in patients undergoing PCI, according to DES type. Methods: In the current sub-analysis from TWILIGHT, patients were stratified into three groups based on DES type: durable polymer everolimus-eluting stents (DP-EES), durable polymer zotarolimus-eluting stents (DP-ZES), and biodegradable polymer DES (BP-DES). Bleeding and ischaemic outcomes were assessed at one year after randomisation. Results: Out of 5,769 patients, 3,014 (52.2%) had DP-EES, 1,350 (23.4%) had DP-ZES and 1,405 (24.4%) had BP-DES. Compared with ticagrelor plus aspirin, ticagrelor monotherapy had significantly lower BARC type 2, 3 or 5 bleeding compared with DAPT; DP-EES (3.8% vs 6.7%; HR 0.56, 95% CI: 0.41-0.78), DP-ZES (4.6% vs 6.9%; HR 0.66, 95% CI: 0.42-1.04) and BP-DES (4.2% vs 7.9%; HR 0.52, 95% CI: 0.33-0.81; pinteraction=0.76). Ticagrelor monotherapy resulted in similar rates of death, MI, or stroke: DP-EES (4.2% vs 4.3%; HR 0.97; 95% CI: 0.68-1.37); DP-ZES (4.1% vs 3.1%; HR 1.32; 95% CI: 0.75-2.33); BP-DES (3.9% vs 4.2%; HR 0.92; 95% CI: 0.54-1.55; pinteraction=0.60). In both unadjusted and covariateadjusted analyses, DES type was not associated with any differences in ischaemic or bleeding complications. Conclusions: As compared with ticagrelor plus aspirin, ticagrelor monotherapy after a short DAPT duration lowered bleeding complications without increasing the ischaemic risk, irrespective of DES type. We observed no significant differences among DES types.
Bibliographical noteFunding Information:
G. Dangas reports receiving consulting fees and advisory board fees from AstraZeneca, consulting fees from Biosensors, and previously holding stock in Medtronic. U. Baber reports speaker honoraria from AstraZeneca and Boston Scientific. S. Sharma has received consulting fees or honoraria from Abbott, Boston Scientific, Abiomed, and Cardiovascular Systems, Inc. S. Mehta has received research grants to the institution from AstraZeneca, Abbott, Boston Scientific, and Sanofi; and has received honoraria for consultancy from AstraZeneca, Bayer, Biosensors, and Sanofi. D. Cohen reports receiving grant support, paid to his institution, and consulting fees from AstraZeneca, Medtronic, Abbott Vascular, and Boston Scientific. D. Angiolillo has received payment as an individual for: a) Consulting fee or honorarium from Abbott, Amgen, Aralez, AstraZeneca, Bayer, Biosensors, Boehringer Ingelheim, Bristol-Myers Squibb, Chiesi, Daiichi-Sankyo, Eli Lilly, Haemonetics, Janssen, Merck, PhaseBio, PLx Pharma, Pfizer, Sanofi, and The Medicines Company; b) participation in review activities from CeloNova, and St. Jude Medical. He has also received institutional payments for grants from Amgen, AstraZeneca, Bayer, Biosensors, CeloNova, CSL Behring, Daiichi-Sankyo, Eisai, Eli-Lilly, Gilead Sciences, Idorsia, Janssen, Matsutani Chemical Industry Co., Merck, Novartis, Osprey Medical, RenalGuard Solutions, and the Scott R. MacKenzie Foundation. J. Escaned reports receiving consulting fees and lecture fees from Abbott, Philips, Boston Scientific, and Medtronic, and lecture fees from Abiomed, Terumo, and Biosensors. K. Huber reports receiving lecture fees from AstraZeneca and Bayer. V. Kunadian has received personal fees/honoraria from Bayer, Astra Zeneca, Abbott, Amgen, and Daichii Sankyo. D. Moliterno reports grants from AstraZeneca, during the conduct of the study. M. Ohman reports research grants from Abiomed and Chiesi, and consulting fees from AstraZeneca, Cara Therapeutics, Faculty Connection, Imbria, Impulse Medical, Janssen Pharmaceuticals, Milestone Pharmaceuticals, Xylocor, and Zoll Medical. G. Weisz reports receiving grant support and advisory board fees from and holding equity in Corindus, advisory board fees from and holding equity in Filterlex, serving on an advisory board for and holding options in Trisol, and receiving grant support from Abbott, CSI, and RenalGuard Solutions. M. Krucoff reports grants and/or personal fees from Abbott Vascular, Biosensors, Boston Scientific, Celonova, Medtronic, OrbusNeich, and Terumo. K. Oldroyd reports receiving grant support and lecture fees from AstraZeneca; and is employed by Biosensors. G. Sardella reports receiving consulting fees from Abbott, Shockwave, Boston Scientific, and Balmed, and payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Abbott, Alvimedica, Shockwave, Medtronic, Biosensors. P.G. Steg reports receiving research grants from Amarin, Bayer, Sanofi, and Servier; compensation for work in clinical trials from Amarin, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Idorsia, Novartis, Pfizer, Sanofi, and Servier; receiving fees for consulting or speaking from Amgen, BMS/Myokardia, Novo-Nordisk, and Regeneron;
TWILIGHT was an international, multicentre, randomised, placebo-controlled trial conducted in 187 sites across 11 countries, as previously described11,13. The Icahn School of Medicine at Mount Sinai designed and sponsored the trial, which was supported by an investigator-initiated grant from AstraZeneca. National regulatory agencies and institutional review boards or ethics committees of participating centres approved the trial protocol. An independent data and safety monitoring board provided external oversight to ensure the safety of the trial participants.
© Europa Digital & Publishing 2022. All rights reserved.
- adjunctive pharmacotherapy
- clinical trials
- drug-eluting stent
ASJC Scopus subject areas
- Cardiology and Cardiovascular Medicine