Key result
Colchicine reduces post-pericardiotomy syndrome ~44% vs. placebo after open heart surgery.
Why the study?
Post-pericardiotomy syndrome is a relatively common complication after open heart surgery, and colchicine has shown efficacy in treating pericarditis.
Does colchicine prevent post-pericardiotomy syndrome in patients undergoing open heart surgery?
RCT (n=240)
Double-blind
Central computer-based, automated sequence
No
Does colchicine prevent post-pericardiotomy syndrome in patients undergoing open heart surgery?
Absolute Event Rate: 12.1% vs 21.6%
p-value: p=<0.05
Colchicine significantly reduces the incidence of post-pericardiotomy syndrome following open heart surgery.
Colchicine warrants consideration to prevent post-pericardiotomy syndrome after open heart surgery; confirms benefit in this RCT amid mixed prior evidence.
Introduction: Post-pericardiotomy syndrome is a relatively common complication after open heart surgery. In recent years, colchicine had a good effect on treatment of the pericarditis. Objectives: This study aimed to study the effect of colchicine to prevent post-pericardiotomy syndrome in patients who had open heart surgery. Patients and Methods: This double-blind clinical trial study was conducted on 240 patients undergone open heart surgery. Eligible patients were selected by simple sampling and randomly divided into two groups; 120 subjects in the experimental group receive colchicine (1 mg for patients greater than 70 kg and 0.5 mg for patients lower than 70 kg) and 120 subjects in the control group who received the placebo. Patients were followed up regarding the incidence of post-pericardiotomy syndrome after the surgery during hospitalization and in follow up visits in one month and six months after hospital discharges. Results: In total, the incidence rate of post-pericardiotomy syndrome was 33.7% (81 subjects). A significant difference of post-pericardiotomy syndrome between two groups was seen. We found post-pericardiotomy syndrome in 12.1% (29 patients) of colchicine group versus 21.6% (52 patients) in the placebo group (chi-square test). The incidence rate based on the Kaplan-Meier curve, in the second week to one month after the surgery, was lower in colchicine group while in third to the sixth month it had a constant trend. Conclusion: Colchicine is effective for prevention the post-pericardiotomy syndrome without any life-threatening complication.
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Mashayekhi et al. (2020) conducted an RCT in Post-pericardiotomy syndrome (PPS) (n=240). Colchicine vs. Placebo was evaluated on Incidence of post-pericardiotomy syndrome (PPS) (p=<0.05). Colchicine significantly reduced the incidence of post-pericardiotomy syndrome compared to placebo in patients who underwent open heart surgery (12.1% vs 21.6%, p<0.05).
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