Low-dose colchicine in patients treated with percutaneous coronary interventions for myocardial infarction in the Colchicine Cardiovascular Outcomes Trial (COLCOT)

Abstract Background/Introduction Experimental and clinical evidence supports the role of inflammation in atherosclerosis and its complications. Colchicine is an orally administered, potent anti-inflammatory medication that was shown to significantly lower the risk of ischemic cardiovascular events compared to placebo among subjects with a recent myocardial infarction (MI) in the main COLCOT trial. Patients treated with percutaneous coronary intervention (PCI) after MI represent an important subpopulation that may derive particularly important benefits from colchicine. Purpose To assess the impact of low-dose colchicine on cardiovascular events in subjects treated with PCI for an index MI. Methods We performed an international, randomized, double-blind trial involving patients recruited within 30 days after a MI (main COLCOT trial; n=4745). In this trial, patients were eligible if they had a confirmed myocardial infarction within 30 days before enrollment, had completed any planned percutaneous revascularization procedures and were treated medically according to national guidelines that included the intensive use of statins. Subjects were randomly assigned to receive oral colchicine 0.5 mg once daily or matching placebo. Among the entire COLCOT study population, 4408 subjects were treated with PCI for the index MI and form the COLCOT-PCI study population. We analyzed the time to the first positively adjudicated event of the composite of CV death, resuscitated cardiac arrest, acute MI, stroke or urgent hospitalization for angina requiring coronary revascularization (primary endpoint). Results In the main COLCOT trial, low-dose colchicine led to a significantly lower risk of the primary endpoint (hazard ratio, 0.77; 95% confidence interval [CI], 0.61 to 0.96; p=0.02). In the COLCOT-PCI subpopulation, low-dose colchicine was associated with a large reduction in the risk of a primary endpoint event (hazard ratio, 0.72; 95% confidence interval [CI], 0.57 to 0.92; p=0.008). The hazard ratios for individual components of the composite primary endpoint were 0.71 (95% CI, 0.37 to 1.33) for death from cardiovascular causes, 0.84 (95% CI, 0.26 to 2.75) for resuscitated cardiac arrest, 0.90 (95% CI, 0.66 to 1.21) for myocardial infarction, 0.25 (95% CI, 0.08 to 0.76) for stroke, and 0.42 (95% CI, 0.25 to 0.71) for urgent hospitalization for angina requiring coronary revascularization. Conclusion Low-dose colchicine markedly reduces the risk of ischemic cardiovascular events in patients treated with PCI for their index MI. Funding Acknowledgement Type of funding source: Other. Main funding source(s): Government of Quebec and Canadian Institutes of Health Research