Introduction Inflammation is key to plaque formation and rupture. Acute MI survivors have increased risk of further events, due to inflammation. Data on colchicine, an established anti-inflammatory, suggests a reduction in cardiovascular events by inflammatory attenuation. It may reduce complications post myocardial infarction (MI), but before this can be tested in a large randomised trial it’s essential to establish feasibility, safety and tolerability. The CANTOS study used this strategy, demonstrating a monoclonal antibody targeting inflammation significantly reduced events in MI survivors with persistently elevated hs-CRP. CANTOS provides the best evidence to date that inflammatory suppression improves outcomes after acute MI. Monoclonal antibody treatment is costly and unlikely to suitable for widespread use with adverse events an issue.
Methods This single centre double-blind randomised controlled trial recruited 238 patients following acute MI (table 1). Adherence was analysed by pill count. Adverse Events were assessed by acceptability questionnaire and laboratory surveillance. hs-CRP levels were measured at baseline and 30 days.
Results 238 were randomised with 219 completing protocol. 8% ceased trial medication prematurely or were lost to follow up. 9 patients suffered GI issues (7 on colchicine) with basic laboratory analysis normal. At 30 day follow up, median hsCRP in the colchicine arm was 1.5 mg/L vs 2.0 mg/L in placebo (p=0.08). Absolute reduction in hsCRP levels in colchicine arm was −4.5 mg/L vs −3.3 mg/L in placebo (p=0.29). Relative reduction was 78% (colchicine) compared to a placebo 64% (p=0.06). 44% in treatment arm had a hsCRP level ≥2 mg/L at 30 days compared to 51%-placebo (p=0.28).
Conclusion No significant reduction in the median level of hsCRP was observed but all were lower in colchicine arm, consistent with prior data. The totality of evidence supports the need for a large-scale outcome trial in patients with recent MI. The current study demonstrates the safety, tolerability of colchicine confirming that patients already receiving many other drugs, find further medication acceptable.
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