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

De Cock, Emmanuel;Kautbally, Shakeel;Timmermans, Frank;Bogaerts, Kris;Buysschaert, Ian;et.al.
(2024) American Heart Journal — n° 278, p. 61-71 (2024)

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Authors
  • De Cock, Emmanuel
    Author
  • Kautbally, ShakeelUCLouvain
    Author
  • Timmermans, Frank
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  • Bogaerts, Kris
    Author
  • Hanet, Claudeorcid-logoUCLouvain
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  • Gurné, OlivierUCLouvain
    Author
  • Guedes, AntoineUCLouvain
    Author
  • Buysschaert, Ian
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Abstract
(en) 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.
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De Cock, E., Kautbally, S., Timmermans, F., Bogaerts, K., Hanet, C., Desmet, W., Gurné, O., Vranckx, P., Hiltrop, N., Dujardin, K., Vanduynhoven, P., Vermeersch, P., Pirlet, C., Hermans, K., Van Reet, B., Ferdinande, B., Aminian, A., Dewilde, W., Guedes, A., et al. (2024). Low-dose colchicine for the prevention of cardiovascular events after percutaneous coronary intervention: rationale and design of the COL BE PCI trial: Short title: Rationale and design of the COL BE PCI trial. American Heart Journal, 278, 61-71. https://doi.org/10.1016/j.ahj.2024.08.022 (Original work published 2024)