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Ticagrelor with or without aspirin following percutaneous coronary intervention in high-risk patients with concomitant peripheral artery disease: A subgroup analysis of the TWILIGHT randomized clinical trial

Lookup NU author(s): Professor Vijay KunadianORCiD

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Abstract

© 2024 Elsevier Inc.Background: The optimal antiplatelet regimen after percutaneous coronary intervention (PCI) in patients with peripheral artery disease (PAD) is still debated. This analysis aimed to compare the effect of ticagrelor monotherapy versus ticagrelor plus aspirin in patients with PAD undergoing PCI. Methods: In the TWILIGHT trial, patients at high ischemic or bleeding risk that underwent PCI were randomized after 3 months of dual antiplatelet therapy (DAPT) to aspirin or matching placebo in addition to open-label ticagrelor for 12 additional months. In this post-hoc analysis, patient cohorts were examined according to the presence or absence of PAD. The primary endpoint was Bleeding Academic Research Consortium (BARC) 2, 3, or 5 bleeding. The key secondary endpoint was a composite of all-cause death, myocardial infarction (MI), or stroke. Endpoints were assessed at 12 months after randomization. Results: Among 7,119 patients, 489 (7%) had PAD and were older, more likely to have comorbidities, and multivessel disease. PAD patients had more bleeding or ischemic complications than no-PAD patients. Ticagrelor monotherapy compared to ticagrelor plus aspirin was associated with less BARC 2, 3, or 5 bleeding in PAD (4.6% vs 8.7%; HR 0.52; 95%CI 0.25-1.07) and no-PAD patients (4.0% vs 7.0%; HR 0.56; 95%CI 0.45-0.69; interaction P-value .830) and a similar risk of death, MI, or stroke in these 2 groups (interaction P-value .446). Conclusions: Despite their higher ischemic and bleeding risk, patients with PAD undergoing PCI derived a consistent benefit from ticagrelor monotherapy after 3 months of DAPT in terms of bleeding reduction without any relevant increase in ischemic events. Clinical trial registry information: https://www.clinicaltrials.gov/study/NCT02270242.

Publication metadata

Author(s): Krucoff M, Spirito A, Baber U, Sartori S, Angiolillo DJ, Briguori C, Cohen DJ, Collier T, Dangas G, Dudek D, Escaned J, Gibson CM, Han Y-L, Huber K, Kastrati A, Kaul U, Kornowski R, Kunadian V, Vogel B, Mehta SR, Moliterno D, Sardella G, Shlofmitz RA, Sharma S, Steg PG, Pocock S, Mehran R

Publication type: Article

Publication status: Published

Journal: American Heart Journal

Year: 2024

Volume: 272

Pages: 11-22

Print publication date: 01/06/2024

Online publication date: 06/03/2024

Acceptance date: 02/03/2024

ISSN (print): 0002-8703

ISSN (electronic): 1097-6744

Publisher: Elsevier Inc.

URL: https://doi.org/10.1016/j.ahj.2024.03.002

DOI: 10.1016/j.ahj.2024.03.002

PubMed id: 38458371

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