Colchicine Cardiovascular Outcomes Trial - COLCOT

Contribution To Literature:

The COLCOT trial showed that colchicine was effective at preventing major adverse cardiac events after a myocardial infarction.

Description:

The goal of the trial was to evaluate colchicine compared with placebo administered within 30 days of a myocardial infarction.

Study Design

  • Randomized
  • Parallel
  • Double-blind

Patients who suffered a myocardial infarction within the last 30 days were randomized to colchicine 0.5 mg daily (n = 2,366) versus placebo (n = 2,379).

  • Total number of enrollees: 4,745
  • Duration of follow-up: median 22.6 months
  • Mean patient age: 61 years
  • Percentage female: 20%
  • Percentage with diabetes: 20%

Inclusion criteria:

  • Myocardial infarction within the last 30 days and completion of all intended coronary revascularization

Exclusion criteria:

  • Type 2 myocardial infarction
  • Severe left ventricular systolic dysfunction or heart failure
  • Stroke within the last 3 months
  • Coronary artery bypass surgery within the last 3 years
  • Cancer within the last 3 years
  • History of inflammatory bowel disease or chronic diarrhea, neuromuscular disease, significant hepatic or renal disease, drug or alcohol abuse, glucocorticoid therapy, or sensitivity to colchicine

Other salient features/characteristics:

  • 93% underwent percutaneous coronary intervention for their index myocardial infarction
  • Mean time from myocardial infarction to randomization was 13.5 days

Principal Findings:

The primary efficacy outcome, cardiovascular death, myocardial infarction, stroke, resuscitated cardiac arrest, or urgent hospitalization for unstable angina leading to revascularization, occurred in 5.5% of the colchicine group compared with 7.1% of the placebo group (p = 0.02).

Secondary outcomes:

  • Cardiovascular death: 0.8% of the colchicine group compared with 1.0% of the placebo group (p = nonsignificant)
  • Stroke: 0.2% of the colchicine group compared with 0.8% of the placebo group (p < 0.05)
  • Urgent hospitalization for unstable angina leading to revascularization: 1.1% of the colchicine group compared with 2.1% of the placebo group (p < 0.05)
  • Infection: 2.2% of the colchicine group compared with 1.6% of the placebo group (p = 0.15)
  • Diarrhea: 9.7% of the colchicine group compared with 8.9% of the placebo group (p = 0.35)

Interpretation:

Among patients who suffered a recent myocardial infarction, low-dose colchicine was effective at preventing major adverse cardiovascular events compared with placebo. Benefit was primarily due to a reduction in the incidence of stroke and urgent hospitalization for unstable angina leading to revascularization. The study drug was well tolerated and associated with a similar incidence of infection and diarrhea compared with placebo. The benefit of colchicine was purported to be due to anti-inflammatory properties of the drug.


References:

Tardif JC, Kouz S, Waters DD, et al. Efficacy and Safety of Low-Dose Colchicine After Myocardial Infarction. N Engl J Med 2019;Nov 16:[Epub ahead of print].

Editorial: Newby LK. Inflammation as a Treatment Target After Acute Myocardial Infarction. N Engl J Med 2019;Nov 16:[Epub ahead of print].

Presented by Dr. Jean-Claude Tardif at the American Heart Association Annual Scientific Sessions (AHA 2019), Philadelphia, PA, November 16, 2019.

Clinical Topics: Acute Coronary Syndromes, Arrhythmias and Clinical EP, Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Prevention, Implantable Devices, SCD/Ventricular Arrhythmias, Aortic Surgery, Cardiac Surgery and Arrhythmias, Interventions and ACS

Keywords: AHA19, AHA Annual Scientific Sessions, Acute Coronary Syndrome, Angina, Unstable, Colchicine, Diarrhea, Heart Arrest, Inflammation, Myocardial Infarction, Myocardial Revascularization, Percutaneous Coronary Intervention, Primary Prevention, Stroke


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