Colchicine Cardiovascular Outcomes Trial - COLCOT

Nov 15, 2020
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Government of Quebec and Canadian Institutes of Health Research
Date Presented:
11/15/2020
Date Published:
11/16/2019
Date Updated:
11/15/2020
Original Posted Date:
11/16/2019
References

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)
  • Colchicine initiated within 0-3 days of a myocardial infarction appeared to reduce adverse ischemic events compared with placebo (HR 0.52, p = 0.007)
  • Genetic associations were found with cardiovascular endpoints and gastrointestinal events among patients treated with colchicine

Patients with diabetes:

  • Cardiovascular death, resuscitated cardiac arrest, myocardial infarction, stroke, or urgent hospitalization for angina requiring revascularization for colchicine vs. placebo: HR 0.65, 95% CI 0.44-0.96
  • Total cardiovascular events for colchicine vs. placebo: HR 0.53, 95% CI 0.33-0.87

Cost-effectiveness:

  • Mean overall per-patient costs were reduced by 47% for the in-trial period and 69% for the lifetime period
  • Quality-adjusted life-years increased

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. Colchicine appeared to be beneficial among patients with diabetes. The study drug was well tolerated and associated with a similar incidence of infection and diarrhea compared with placebo. Colchicine was also cost-effective. The benefit of colchicine was purported to be due to anti-inflammatory properties of the drug.

References:

Presented by Dr. Francois Roubille at the American Heart Association Virtual Scientific Sessions, November 15, 2020.

Bouabdallaoui N, Tardif JC, Waters DD, et al. Time-to-treatment initiation of colchicine and cardiovascular outcomes after myocardial infarction in the Colchicine Cardiovascular Outcomes Trial (COLCOT). Eur Heart J 2020;Aug 29:[Epub ahead of print].

Presented by Dr. Nadia Bouabdallaoui at the European Society of Cardiology Virtual Congress, August 29, 2020.

Presented by Dr. Michelle Samuel at the American College of Cardiology Virtual Annual Scientific Session Together With World Congress of Cardiology (ACC 2020/WCC), March 28, 2020.

Tardif JC, Kouz S, Waters DD, et al. Efficacy and Safety of Low-Dose Colchicine After Myocardial Infarction. N Engl J Med 2019;381:2497-505.

Editorial: Newby LK. Inflammation as a Treatment Target After Acute Myocardial Infarction. N Engl J Med 2019;381:2562-3.

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: AHA20, AHA Annual Scientific Sessions, ESC20, ESC Congress, acc20, ACC Annual Scientific Session, AHA19, Acute Coronary Syndrome, Angina, Unstable, Colchicine, Diabetes Mellitus, Diarrhea, Heart Arrest, Inflammation, Myocardial Infarction, Myocardial Revascularization, Percutaneous Coronary Intervention, Primary Prevention, Stroke


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