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 - 04/05/24

Doi : 10.1016/j.ahj.2024.03.002

Mitchell Krucoff, MD ^a,^{^{#
These authors contribute equally to this work}}, Alessandro Spirito, MD ^b,^{^{#
These authors contribute equally to this work}}, Usman Baber, MD, MS ^c, Samantha Sartori, PhD ^b, Dominick J. Angiolillo, MD, PhD ^d, Carlo Briguori, MD, PhD ^e, David J. Cohen, MD, MSc ^f,^g, Timothy Collier, MSc ^h, George Dangas, MD, PhD ^b, Dariusz Dudek, MD, PhD ⁱ, Javier Escaned, MD, PhD ^j, C. Michael Gibson, MD, MSc ^k, Ya-Ling Han, MD, PhD ^l, Kurt Huber, MD ^m,ⁿ, Adnan Kastrati, MD ^o, Upendra Kaul, MD ^p, Ran Kornowski, MD ^q, Vijay Kunadian, MBBS, MD ^r,^s, Birgit Vogel, MD ^b, Shamir R. Mehta, MD ^t, David Moliterno, MD ^u, Gennaro Sardella, MD ^v, Richard A. Shlofmitz, MD ^g, Samin Sharma, MD ^b, Philippe Gabriel Steg, MD ^w, Stuart Pocock, PhD ^h, Roxana Mehran, MD ^b,^⁎
^a Division of Cardiology, Department of Medicine, Duke University Medical Center, Duke Clinical Research Institute, Durham, NC
^b The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA
^c Department of Cardiology, The University of Oklahoma Health Sciences Center, Oklahoma City, OK
^d Division of Cardiology, University of Florida College of Medicine, Jacksonville, FL
^e Mediterranea Cardiocentro, Naples, Italy
^f Cardiovascular Research Foundation, New York, NY
^g St. Francis Hospital, Roslyn, Roslyn, NY
^h Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, United Kingdom
ⁱ Jagiellonian University Medical College, Krakow, Poland
^j Hospital Clínico San Carlos IDISCC, Complutense University of Madrid, Madrid, Spain
^k Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA
^l General Hospital of Northern Theater Command, No. 83 Wenhua Road, Shenyang 110016, China
^m Third Department Medicine, Cardiology and Intensive Care Medicine, Wilhelminen Hospital, Vienna, Austria
ⁿ Sigmund Freud University, Medical Faculty, Vienna, Austria
^o Deutsches Herzzentrum München, Munich, Germany
^p Batra Hospital and Medical Research Centre, New Delhi, India
^q Rabin Medical Center, Petach Tikva, Israel
^r Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom
^s Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom
^t Hamilton Health Sciences, Hamilton, Ontario, Canada
^u Division of Cardiovascular Medicine, University of Kentucky, Lexington, KY
^v Policlinico Umberto I University, Rome, Italy
^w Université Paris-Cité, Paris, France

^⁎Reprint requests: Roxana Mehran, MD, Professor of Medicine, Icahn School of Medicine at Mount Sinai, 1 Gustav L. Levy Place, Box 1030, New York, NY 10029, Phone: +1 212 659 9649, Fax: +1 646 537 8547.Professor of MedicineIcahn School of Medicine at Mount Sinai1 Gustav L. Levy Place, Box 1030New YorkNY10029

ABSTRACT

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:

NCT02270242.

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Plan

Population characteristics

Outcomes by PAD status

Treatment effect on bleeding events

Treatment effect on ischemic events

Data availability statement

CRediT authorship contribution statement

Andreas P Kalogeropoulos, MD, PhD served as Guest Editor for this manuscript.

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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 - 04/05/24

ABSTRACT

Background

Methods

Results

Conclusions

Clinical trial registry information:

Plan

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