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Published on: February 28, 2012
Colchicine for Prevention of Atrial Fibrillation after Cardiac Surgery in the Early Postoperative Period
Vladimir Shvartz1, Tatyana Le1, Yuri Kryukov2
1Department of Surgical Treatment for Interactive Pathology, Bakoulev Scientific Center for Cardiovascular Surgery, 121552 Moscow, Russia.
Insights
Short-term colchicine did not significantly prevent postoperative atrial fibrillation (POAF) after heart surgery. Further research with larger sample sizes is needed to explore potential benefits and side effects like diarrhea.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Postoperative atrial fibrillation (POAF) is a frequent complication following cardiac surgery, increasing morbidity, mortality, and healthcare costs.
- Colchicine is recommended by ACC/AHA for POAF prevention (Class IIB), but evidence remains inconclusive.
- Existing research on colchicine's efficacy and safety for POAF requires further investigation.
Purpose of the Study:
- To evaluate the effectiveness of short-term colchicine administration in preventing POAF in patients undergoing open-heart surgery.
- To assess the safety profile of perioperative colchicine use in this patient population.
Main Methods:
- A double-blind, randomized, placebo-controlled trial involving 101 patients undergoing open-heart surgery.
- Patients received either 1 mg of colchicine or placebo 24 hours pre-surgery and on postoperative days 2-5.
- The primary endpoint was the incidence of POAF within 7 days post-surgery.
Main Results:
- No statistically significant difference in POAF incidence between the colchicine (18%) and placebo (29.4%) groups (p=0.178).
- Diarrhea occurred significantly more often in the colchicine group (32%) compared to placebo (11.8%) (p=0.010).
- No significant differences were observed in secondary endpoints or laboratory parameters.
Conclusions:
- Short-term colchicine administration did not demonstrate a statistically significant reduction in POAF incidence in this study.
- The study's sample size may have been insufficient to detect a significant effect.
- Further research is warranted to clarify colchicine's role in POAF prevention, considering observed trends and side effects.
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.
Clinicaltrials:
Unique identifier: NCT04224545.
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