2023-10-03 11:06:05
Why is this important?
Patients undergoing major noncardiac thoracic surgery are at risk of atrial fibrillation and postsurgical myocardial injury. Inflammation appears to be one of the most important predisposing factors. The idea of intervening as prophylaxis with an anti-inflammatory treatment has therefore been the subject of investigation. The use of colchicine – an inexpensive molecule with a well-known pharmacological profile – was evaluated in small, conclusive randomized studies, followed by two larger trials (LoDoCo2, COLCOT), both of which demonstrated a significant reduction in major cardiovascular complications in coronary patients. This study aimed to measure its effectiveness in preventing cardiovascular complications following non-cardiac thoracic surgery, a context in which no study has yet been conducted. It shows a lack of effectiveness on AF compared to that observed in cardiac surgery: in the latter case, AF might be more strongly associated with inflammation than in thoracic surgery.
Methodology
COP-AF is a pilot study conducted on patients aged 55 or over undergoing major non-cardiac thoracic surgery requiring at least 24 hours of hospitalization. They were randomized (1:1) between treatment with oral colchicine 0.5 mg or a placebo administered twice a day for 10 days, the first dose taking place in the 4 hours preceding the intervention. Co-endpoints were the 14-day occurrence of clinically significant AF (requiring treatment or leading to heart failure, hypotension or angina) and the occurrence of myocardial injury (MINS, myocardial infarction or elevation of troponin considered to be of ischemic origin)s.
Principle results
In total, 3,209 patients were recruited (mean age 68 years, 48.4% women). Most were operated on for a lobectomy (63.6%), and 92.9% of patients had been operated on for a suspected or confirmed tumor pathology.
At 14 days of follow-up, the occurrence of clinically significant AF concerned 6.4% and 7.5% of patients treated with colchicine and placebo respectively (absolute risk ratio or RRa 1.1% [-0,7 à 2,8]p=0.22) and that of a MINS in 18.3% and 20.3% of them respectively (RRa 2.0% [-0,8-4,7], p=0.16). Overall, 80.7% and 97.7% of these two types of events occurred before the 6th postoperative day. Secondary endpoints were also equivalent between the two groups of patients: all-cause mortality, non-fatal MINS, non-fatal stroke.
According to post-hoc analysis, a significant difference emerged between the two treatments when integrated into a single composite endpoint (22.4% vs 25,9%, HR 0,84 [0,73-0,97]). The same was true for the composite secondary endpoint (cardiovascular mortality, non-fatal MINS, non-fatal stroke and significant perioperative AF: 22.6 vs 26,4%, HR 0,83 [0,72-0,96]).
In terms of safety, the composite endpoint of sepsis or infection was comparable between the two groups (6.4% vs 5,2%, HR 1,24 [0,93-1,66]). The incidence of non-infectious diarrhea was higher under colchicine (8.3% vs 2,4%).
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