Colchicine for reducing complications after major thoracic surgery falls short

medwireNews: Among people undergoing major thoracic surgery, treatment with colchicine did not significantly reduce the incidence of clinically important atrial fibrillation (AF) or myocardial injury after noncardiac surgery (MINS) in the COP-AF study. And colchicine was associated with a nearly fourfold higher incidence of noninfectious diarrhea than placebo, investigator David Conen (Population Health Research Institute, Hamilton, Ontario, Canada) said at the ESC Congress 2023 in Amsterdam, the Netherlands. But he noted in a press release that “several results provide an encouraging signal of benefit for colchicine to reduce the incidence of adverse cardiovascular outcomes in patients undergoing major non-cardiac thoracic surgery.” Conen continued: “Future trials should further investigate the role of colchicine in the prevention of these events in patients undergoing surgery.” The current trial, which was simultaneously published in The Lancet, included 3209 individuals aged 55 years or older who were scheduled for major noncardiac thoracic surgery under general anesthesia. They were randomly allocated to take colchicine 0.5 mg or placebo twice daily, starting within 4 hours before surgery and continuing for 10 days. The co-primary endpoints of the study were clinically important AF – defined as AF that results in angina, heart failure, or symptomatic hypotension or requires treatment with a rate-controlling or anti-arrhythmic drug or electrical cardioversion – and MINS, defined as myocardial infarction or myocardial ischemia-related elevation in postoperative troponin levels. At 14 days after surgery, clinically important AF and MINS occurred in a numerically smaller proportion of patients in the colchicine than placebo group, at 6.4% versus 7.5%, and 18.3% versus 20.3%, respectively, but the between-group differences were not statistically significant (hazard ratios [HRs]=0.85 and 0.89, respectively]. “Directionally consistent but non-significant effects were observed for the key secondary outcomes,” such as the composite outcome of all-cause mortality, nonfatal myocardial infarction, and nonfatal stroke and MINS not fulfilling the fourth universal definition of myocardial infarction, note the researchers. And post-hoc analyses showed a significant reduction in the risk for the composite outcome of clinically important AF or MINS (HR=0.84) and for the composite of vascular death, non-fatal MINS, non-fatal stroke, or clinically important AF (HR=0.83). One of the key safety outcomes of the trial was a composite of sepsis or infection, which occurred in a comparable 6.4% of patients in the colchicine group and 5.2% of those in the placebo group. The other key outcome was noninfectious diarrhea, and this was reported in 8.3% of colchicine-treated and 2.4% of placebo-treated participants. The presenter highlighted, however, that the cases of diarrhea were “mostly transient and benign,” resolving in a median of 3 days in both groups and leading to a readmission in just one patient in the colchicine arm. The study authors say in the discussion that “[o]ur results seem to differ from randomised trials in patients undergoing cardiac surgery,” adding that “[s]everal potential explanations could account for the observed difference.” For instance, “perioperative atrial fibrillation after cardiac surgery might be more strongly associated with inflammation than atrial fibrillation after thoracic surgery,” they write. medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2023 Springer Healthcare Ltd, part of the Springer Nature Group ESC Congress 2023; Amsterdam, the Netherlands: 25–28 August Lancet 2023; doi:10.1016/S0140-6736(23)01689-6

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Colchicine for reducing complications after major thoracic surgery falls short

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