Colchicine to Improve Cardiovascular Outcomes in ACS Patients - COPS

Contribution To Literature:

The COPS trial showed that colchicine does not improve cardiovascular (CV) outcomes at 365 days compared with placebo among patients presenting with ACS; non-CV mortality appeared to be higher with colchicine.

Description:

The goal of the trial was to assess the safety and efficacy of colchicine in patients with recent acute coronary syndrome (ACS).

Study Design

Patients were randomized in a 1:1 fashion to either colchicine 0.5 mg BID for 1 month, followed by 0.5 mg daily for 11 months, or matching placebo.

  • Total screened: 2,167
  • Total number of enrollees: 795
  • Duration of follow-up: 12 months
  • Mean patient age: 59.8 years
  • Percentage female: 20%

Inclusion criteria:

  • Age ≥18 years
  • ACS managed with percutaneous coronary intervention (PCI) or medically
  • Angiographic evidence of coronary artery disease

Other salient features/characteristics:

  • ST-segment elevation myocardial infarction (STEMI): 50%, NSTEMI: 46%
  • PCI: 87%
  • Statin: 99%
  • Beta-blocker: 83%

Principal Findings:

The primary outcome, death from any cause, acute coronary syndrome (STEMI/NSTEMI/unstable angina), ischemia-driven urgent revascularization and non-cardioembolic ischemic stroke, at 365 days for colchicine vs. placebo, was 6.1% vs. 9.5% (p = 0.09).

  • ACS events: 11 vs. 20 (p = 0.13)
  • Urgent revascularization: 3 vs. 12 (p = 0.037)

Secondary outcomes:

  • All-cause mortality: 8 vs. 1 (p = 0.047)
  • Non-CV death: 5 vs. 0 (p = 0.023)
  • Primary endpoint at 400 days: 24 vs. 41 events (p = 0.047)

Interpretation:

The results of this trial indicate that colchicine does not improve CV outcomes at 365 days compared with placebo among patients presenting with ACS. There was a concerning signal for mortality, particularly non-CV mortality, with colchicine use.

These are interesting findings. COLCOT was a larger trial that showed a benefit in ischemic outcomes among a similar high-risk population. In that trial, there was a neutral effect on death (1.8% vs. 1.8%) and benefit was predominantly driven by a reduction in urgent revascularizations. LoDoCo2 will also be presented soon; results of this trial are eagerly awaited.

References:

Tong DC, Quinn S, Nasis A, et al. Colchicine in Patients with Acute Coronary Syndrome: The Australian COPS Randomized Clinical Trial. Circulation 2020;Aug 29:[Epub ahead of print].

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

Clinical Topics: Acute Coronary Syndromes, Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Prevention, Stable Ischemic Heart Disease, Vascular Medicine, Atherosclerotic Disease (CAD/PAD), Aortic Surgery, Cardiac Surgery and Arrhythmias, Cardiac Surgery and SIHD, Interventions and ACS, Interventions and Coronary Artery Disease, Interventions and Imaging, Interventions and Vascular Medicine, Angiography, Nuclear Imaging, Chronic Angina

Keywords: ESC Congress, ESC20, Acute Coronary Syndrome, Angina, Unstable, Coronary Angiography, Colchicine, Coronary Artery Disease, Myocardial Infarction, ST Elevation Myocardial Infarction, Myocardial Ischemia, Myocardial Revascularization, Percutaneous Coronary Intervention, Stroke, Secondary Prevention, Vascular Diseases


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