Key result
Short-term colchicine fails to reduce postoperative atrial fibrillation compared to placebo.
Why the study?
Postoperative AF is a common complication of cardiac surgery, and research results regarding the efficacy and safety of colchicine for its prevention remain ambiguous.
Does short-term colchicine administration prevent postoperative atrial fibrillation in patients after open-heart surgery?
RCT (n=101)
Double-blind
randomly assigned
Does short-term colchicine administration prevent postoperative atrial fibrillation in patients after open-heart surgery?
Effect estimate: OR 0.527 (95% CI 0.206-1.349)
Absolute Event Rate: 18% vs 29.4%
p-value: p=0.178
Short-term perioperative colchicine administration did not significantly reduce the incidence of postoperative atrial fibrillation after open-heart surgery but significantly increased the risk of diarrhea, though the study was likely underpowered.
Colchicine should not be used routinely for POAF prevention; leaves open efficacy in larger powered RCTs.
Background. Postoperative atrial fibrillation (POAF) is a common complication of cardiac surgery. It has been proven to be associated with an increase in the incidence of early complications and mortality, an increase in the rate of hospital stay duration, and economic costs of their treatment. One of the pharmaceutical drugs recommended by the American College of Cardiology (ACC)/American Heart Association (AHA) for preventing POAF is colchicine (class IIB). However, the results of research on the efficacy and safety of colchicine are ambiguous and, consequently, require further study. Objective. Evaluating the efficacy of short-term colchicine administration in the prevention of POAF in patients after open-heart surgery. Materials and methods. Double-blind, randomized, placebo-controlled clinical trial. The subjects were randomly assigned to two groups: treatment group (n = 50) with subjects receiving 1 mg of colchicine 24 h before the surgery, as well as on days 2, 3, 4, and 5 in the postoperative period; and the control group (n = 51), receiving placebo on the same schedule. The primary endpoint was the frequency of POAF in both groups within 7 days after surgery. Results. The study included 101 patients (82 men, 19 women). Baseline clinical, laboratory, instrumental, and intraoperative data did not differ statistically significantly between the groups. POAF was detected in 9 patients (18%) of the treatment group and 15 subjects (29.4%) of the control group, which had no statistical significance (odds ratio, OR 0.527; 95% Cl 0.206–1.349; p = 0.178). No statistically significant differences were revealed for most secondary endpoints, as well as between the groups for all laboratory parameters. There were statistically significant differences between the groups solely in the frequency of diarrhea: 16 (32%) patients in the treatment group and 6 (11.8%) subjects in the control group (OR 3.529; 95% Cl 1.249–9.972; p = 0.010). Conclusions. We did not detect any statistical differences between the groups in terms of primary endpoints, which could be due to the insufficient volume of the sample of the study. However, we detected some trends of statistical differences among the groups in terms of some parameters. Clinical Trials Registration. ClinicalTrials. Unique identifier: NCT04224545.
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Shvartz et al. (2022) conducted an RCT in Postoperative atrial fibrillation after open-heart surgery (n=101). Colchicine vs. Placebo was evaluated on Frequency of postoperative atrial fibrillation within 7 days after surgery (OR 0.527, 95% CI 0.206-1.349, p=0.178). Short-term colchicine administration did not significantly reduce the frequency of postoperative atrial fibrillation compared to placebo (18% vs 29.4%; OR 0.527; 95% CI 0.206-1.349; p=0.178).
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