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

• Published in: The American heart journal Vol. 278; pp. 61 - 71
• Main Authors: De Cock, Emmanuel, Kautbally, Shakeel, Timmermans, Frank, Bogaerts, Kris, Hanet, Claude, Desmet, Walter, Gurné, Olivier, Vranckx, Pascal, Hiltrop, Nick, Dujardin, Karl, Vanduynhoven, Philippe, Vermeersch, Paul, Pirlet, Charles, Hermans, Kurt, Van Reet, Bert, Ferdinande, Bert, Aminian, Adel, Dewilde, Willem, Guédès, Antoine, Simon, François, De Roeck, Frederic, De Vroey, Frédéric, Jukema, J. Wouter, Sinnaeve, Peter, Buysschaert, Ian
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.12.2024; Elsevier Limited
• Subjects: Angina pectoris; Angioplasty; Anti-inflammatory agents; Arteriosclerosis; At risk populations; Atherosclerosis; Cardiovascular disease; Cardiovascular diseases; Cerebral infarction; Colchicine; Compliance; Coronary artery disease; Coronary vessels; Disease prevention; Drug dosages; Effectiveness; Heart attacks; Heart diseases; Inflammation; Laboratories; Meta-analysis; Myocardial infarction; Pathogenesis; Patients; Performance evaluation; Prevention; Questionnaires; Randomization; Stroke; Thrombosis; Vein & artery diseases; ACS; CCS; OD; PHQ-2; PCI; hsCRP; EQ-5D-5L; SMART; SAQ-7
• ISSN: 0002-8703; 1097-6744; 1097-6744
• DOI: 10.1016/j.ahj.2024.08.022

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. 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. 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. [Display omitted]