Low-dose colchicine for the prevention of cardiovascular events after percutaneous coronary intervention: Rationale and design of the COL BE PCI trial.

Autor: De Cock E; Department of Cardiology, AZ Sint-Jan Brugge AV, Bruges, Belgium; Department of Cardiology, Ghent University Hospital, Ghent, Belgium., Kautbally S; Department of Cardiology, Cliniques Universitaires St-Luc, Université Catholique de Louvain, Brussels, Belgium., Timmermans F; Department of Cardiology, Ghent University Hospital, Ghent, Belgium., Bogaerts K; Department of Public Health and Primary Care, KU Leuven, I-BioStat, Leuven, Belgium and UHasselt, I-BioStat, Diepenbeek, Belgium., Hanet C; Department of Cardiology, Université Catholique de Louvain, Mont Godinne, Yvoir, Belgium., Desmet W; Department of Cardiovascular Sciences, University of Leuven, Leuven, Belgium; Belgium & Department of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium., Gurné O; Department of Cardiology, Cliniques Universitaires St-Luc, Université Catholique de Louvain, Brussels, Belgium., Vranckx P; Department of Cardiology and Intensive Care Medicine, Jessa Ziekenhuis, Hasselt, Belgium., Hiltrop N; Department of Cardiology, AZ Groeninge, Kortrijk, Belgium., Dujardin K; Department of Cardiology, AZ Delta, Roeselare, Belgium., Vanduynhoven P; Department of Cardiology, Arrhythmia Clinic, ASZ Aalst, Aalst, Belgium., Vermeersch P; Department of Cardiology, ZNA (Ziekenhuis Netwerk Antwerpen) Middelheim, Antwerp, Belgium., Pirlet C; Department of Cardiology, Citadelle Liège, Liège, Belgium., Hermans K; Department of Cardiology, AZ Sint-Lucas Ghent, Ghent, Belgium., Van Reet B; Department of Cardiology, AZ Turnhout, Turnhout, Belgium., Ferdinande B; Department of Cardiology, Hospital Oost-Limburg, Genk, Belgium., Aminian A; Department of Cardiology, Centre Hospitalier Universitaire de Charleroi, Charleroi, Belgium., Dewilde W; Department of Cardiology, Imelda Hospital Bonheiden, Bonheiden, Belgium., Guédès A; Department of Cardiology, Université Catholique de Louvain, Mont Godinne, Yvoir, Belgium., Simon F; Department of Cardiology, Clinique Saint-Luc Bouge, Namur, Belgium., De Roeck F; Department of Cardiology, University Hospital Antwerp, Edegem, Belgium., De Vroey F; Department of Cardiology, Grand Hôpital de Charleroi, Charleroi, Belgium., Jukema JW; Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands; Netherlands Heart Institute, Utrecht, The Netherlands., Sinnaeve P; Department of Cardiovascular Sciences, University of Leuven, Leuven, Belgium; Belgium & Department of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium., Buysschaert I; Department of Cardiology, AZ Sint-Jan Brugge AV, Bruges, Belgium. Electronic address: ian.buysschaert@azsintjan.be.
Jazyk: angličtina
Zdroj: American heart journal [Am Heart J] 2024 Dec; Vol. 278, pp. 61-71. Date of Electronic Publication: 2024 Sep 02.
DOI: 10.1016/j.ahj.2024.08.022
Abstrakt: Introduction: Patients with coronary artery disease (CAD) remain vulnerable to future major atherosclerotic events after revascularization, despite effective secondary prevention strategies. Inflammation plays a central role in the pathogenesis of CAD and recurrent events. To date, there is no specific anti-inflammatory medicine available with proven effective, cost-efficient, and favorable benefit-risk profile, except for colchicine. Initial studies with colchicine have sparked major interest in targeting atherosclerotic events with anti-inflammatory agents, but further studies are warranted to enforce the role of colchicine role as a major treatment pillar in CAD. Given colchicine's low cost and established acceptable long-term safety profile, confirming its efficacy through a pragmatic trial holds the potential to significantly impact the global burden of cardiovascular disease.
Methods: The COL BE PCI trial is an investigator-initiated, multicenter, double-blind, event-driven trial. It will enroll 2,770 patients with chronic or acute CAD treated with percutaneous coronary intervention (PCI) at 19 sites in Belgium, applying lenient in- and exclusion criteria and including at least 30% female participants. Patients will be randomized between 2 hours and 5 days post-PCI to receive either colchicine 0.5 mg daily or placebo on top of contemporary optimal medical therapy and without run-in period. All patients will have baseline hsCRP measurements and a Second Manifestations of Arterial Disease (SMART) risk score calculation. The primary endpoint is the time from randomization to the first occurrence of a composite endpoint consisting of all-cause death, spontaneous non-fatal myocardial infarction, non-fatal stroke, or coronary revascularization. The trial is event-driven and will continue until 566 events have been reached, providing 80% power to detect a 21 % reduction in the primary endpoint taking a premature discontinuation of 15% into account. We expect a trial duration of approximately 44 months.
Conclusion: The COL BE PCI Trial aims to assess the effectiveness and safety of administering low-dose colchicine for the secondary prevention in patients with both chronic and acute coronary artery disease undergoing PCI.
Trial Registration: ClinicalTrials.gov: NCT06095765.
Competing Interests: Conflict of Interest The authors have no conflict of interest related to the content of this paper.
(Copyright © 2024 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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