Mauro Gitto; Usman Baber; Samantha Sartori; Birgit Vogel; Dominick Angiolillo; Carlo Briguori; David Cohen; Timothy Collier; Dariusz Dudek; Angelo Oliva; Javier Escaned; Yihan Feng; C. Gibson; Ya-ling Han; Francesca Di Muro; Richard Shlofmitz; Kurt Huber; Philippe Steg; Samin Sharma; Gennaro Sardella; Adnan Kastrati; Upendra Kaul; Ran Kornowski; Vijay Kunadian; Giulio Stefanini; Shamir Mehta; George Dangas; Roxana Mehran

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 Gitto¹^,², MD; Usman Baber³, MD; Samantha Sartori¹, PhD; Birgit Vogel¹, MD; Dominick J. Angiolillo⁴, MD, PhD; Carlo Briguori⁵, MD, PhD; David J. Cohen⁶^,⁷, MD, MSc; Timothy Collier⁸, MSc; Dariusz Dudek⁹, MD, PhD; Angelo Oliva¹^,², MD; Javier Escaned¹⁰, MD, PhD; Yihan Feng¹, MS; C. Michael Gibson¹¹, MD, MSc; Ya-Ling Han¹², MD, PhD; Francesca Maria Di Muro¹, MD; Richard A. Shlofmitz⁷, MD; Kurt Huber¹³^,¹⁴, MD; Philippe Gabriel Steg¹⁵, MD; Samin Sharma¹, MD; Gennaro Sardella¹⁶, MD; Adnan Kastrati¹⁷, MD; Upendra Kaul¹⁸, MD; Ran Kornowski¹⁹, MD; Vijay Kunadian²⁰^,²¹, MBBS, MD; Giulio G. Stefanini²²^,², MD, PhD; Shamir R. Mehta²³, MD; George Dangas¹, MD; Roxana Mehran¹, MD

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, p_interaction=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; p_interaction=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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