Clinically Driven Revascularization in High-Risk Patients Treated With Ticagrelor Monotherapy After PCI: Insights from the Randomized TWILIGHT Trial - 08/11/23

Doi : 10.1016/j.amjcard.2023.09.008

Usman Baber, MD, MS ^a, Alessandro Spirito, MD ^b, Samantha Sartori, PhD ^b, Dominick J. Angiolillo, MD, PhD ^c, Carlo Briguori, MD, PhD ^d, David J. Cohen, MD, MSc ^e,^f, Timothy Collier, MSc ^g, George Dangas, MD, PhD ^b, Dariusz Dudek, MD, PhD ^h, Javier Escaned, MD, PhD ⁱ, C. Michael Gibson, MD, MSc ^j, Ya-Ling Han, MD, PhD ^k, Kurt Huber, MD ^l,^m, Adnan Kastrati, MD ⁿ, Upendra Kaul, MD ^o, Ran Kornowski, MD ^p, Mitchell Krucoff, 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 ^f, Samin Sharma, MD ^b, Philippe Gabriel Steg, MD ^w, Stuart Pocock, PhD ^g, Roxana Mehran, MD ^b,^⁎
^a Department of Cardiology, The University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma
^b The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York
^c Division of Cardiology, University of Florida College of Medicine, Jacksonville, Florida
^d Mediterranea Cardiocentro, Naples, Italy
^e Cardiovascular Research Foundation, New York, New York
^f St. Francis Hospital, Roslyn, New York
^g Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, United Kingdom
^h Jagiellonian University Medical College, Krakow, Poland
ⁱ Hospital Clínico San Carlos IDISCC, Complutense University of Madrid, Madrid, Spain
^j Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts
^k General Hospital of Northern Theater Command, Shenyang, China
^l Third Department Medicine, Cardiology and Intensive Care Medicine, Wilhelminen Hospital, Vienna, Austria
^m Sigmund Freud University, Medical Faculty, Vienna, Austria
ⁿ Deutsches Herzzentrum München, Munich, Germany
^o Batra Hospital and Medical Research Centre, New Delhi, India
^p Rabin Medical Center, Petach Tikva, Israel
^q Division of Cardiology, Department of Medicine, Duke University Medical Center, Duke Clinical Research Institute, Durham, North Carolina
^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, Kentucky
^v Policlinico Umberto I University, Rome, Italy
^w Université Paris-Cité, Paris, France

^⁎Corresponding author: Tel: +1 212 659 9649; fax: +1 646 537 8547.

Résumé

Repeat coronary revascularization is a common adverse event after successful percutaneous coronary intervention. This analysis aimed to assess the effects of ticagrelor monotherapy on repeat clinically driven revascularization (CDR). In the TWILIGHT (Ticagrelor With Aspirin or Alone in High-Risk Patients after Coronary Intervention) trial, after 3 months of ticagrelor plus aspirin, high-risk patients were maintained on ticagrelor and randomly allocated to aspirin or placebo for 1 year. The primary end point of this analysis was CDR within 12 months after randomization. The key secondary end points were major adverse cardiovascular and cerebrovascular events (MACCEs), a composite of all-cause death, myocardial infarction, stroke, or CDR, and net adverse clinical events (NACEs), including the individual components of MACCEs and clinically relevant bleeding. The analysis was performed in the per-protocol population. CDR occurred in 473 of 7,039 patients and was associated with a significantly higher risk of subsequent all-cause death, myocardial infarction, or stroke (adjusted hazard ratios [HRs] 2.92, 95% confidence interval [CI] 1.82 to 4.67). Ticagrelor monotherapy was associated with a similar 12-month risk of CDR (7.1% vs 6.6%; HR 1.09, 95% CI 0.90 to 1.30, p = 0.363) and MACCEs (8.9% vs 8.6%; HR 1.04, 95% CI 0.89 to 1.22, p = 0.619), and a lower risk of NACEs (12.2% vs 14.6%; HR 0.83 95% CI 0.73 to 0.94, p = 0.004) than ticagrelor plus aspirin. In conclusion, among high-risk patients who underwent percutaneous coronary intervention, ticagrelor monotherapy after 3 months of ticagrelor-based dual antiplatelet therapy was associated with a similar risk of CDR and MACCEs and a decrease of NACEs (TWILIGHT: NCT02270242).

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Keywords : clinically driven revascularization, percutaneous coronary intervention, repeat revascularization, ticagrelor monotherapy

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	Drs. Baber and Spirito contributed equally to this work.
	The analysis was performed at Mount Sinai Hospital, New York, New York.
	Funding: The TWILIGHT trial was an investigator-initiated trial designed, coordinated, and sponsored by the Icahn School of Medicine at Mount Sinai (New York, New York). AstraZeneca provided an investigator-initiated grant and supplied ticagrelor for the trial.

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P. 16-24 - décembre 2023 Retour au numéro

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Clinically Driven Revascularization in High-Risk Patients Treated With Ticagrelor Monotherapy After PCI: Insights from the Randomized TWILIGHT Trial - 08/11/23

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