Colchicine and Major Adverse Cardiovascular Events in Patients With Established Coronary or Cerebrovascular Atherosclerotic Disease: A Systematic Review and Meta-Analysis of Randomised Controlled Trials
Abstract
Colchicine entered secondary-prevention guidelines on the strength of early randomised trials, but three large trials reported since 2024 have been neutral. We quantified its effect on major adverse cardiovascular events (MACE) and explored potential sources of heterogeneity between trials. We searched PubMed/MEDLINE, Embase, Cochrane CENTRAL, Scopus, and trial registries to 30 June 2026 for randomised trials of oral colchicine versus placebo or usual care in adults with established coronary or cerebrovascular atherosclerotic disease, requiring at least three months of planned treatment and a composite MACE outcome. Risk ratios (RRs) were pooled using DerSimonian-Laird random-effects models; bias was appraised with RoB 2 and certainty with GRADE. All subgroup, meta-regression, and publication-bias analyses were regarded as exploratory. Eight trials (30,392 participants) were included. MACE occurred in 1,138 of 15,199 patients receiving colchicine (7.5%) and 1,361 of 15,193 controls (9.0%): RR 0.75 (95% CI 0.62-0.89; p = 0.001), or 23 fewer events per 1,000 treated. Heterogeneity was substantial (I² = 76.7%), the 95% prediction interval (0.44-1.28) crossed unity, and the Hartung-Knapp-corrected interval reached the null (0.56-1.00). In exploratory analyses, estimates were smaller in larger trials (RR 0.85 vs 0.42) and in trials published in 2024-2025 (0.94 vs 0.59), and the funnel plot was asymmetric; these signals are correlated with one another and with population, design,…
How strong is the evidence?
Evidence Hub reads this as a meta-analysis, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid. Reported size: 30,392 participants or records.
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