Administration of colchicine to patients with aortic stenosis receiving percutaneous aortic valve replacement (TAVR/TAVI) is associated with reduced risk of cardiac arrhythmia and conduction disturbances post-TAVI, study finds presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2024 congress in Washington, which however had to be stopped prematurely due to an excess of vascular accidents cerebral (stroke) under colchicine.
An inflammatory response may be involved in the development of de novo atrial fibrillation after TAVI, underlines Thomas Pilgrim from the University Hospital of Bern in his presentation given in the Late-Breaking Clinical Science session. An inflammatory environment promotes cardiac arrhythmias and colchicine has already been shown to be effective in preventing atrial fibrillation after cardiac surgery, he recalls.
Colchicine was therefore evaluated in patients receiving TAVI, in the Co-STAR trial, the main objective of which was to see its effect on the reduction of cardiac arrhythmias and conduction disturbances post-TAVI. Included patients with symptomatic severe aortic stenosis were randomized between colchicine for 14 days starting the day before surgery and a placebo. It was planned to include 200 patients in the study, with an interim analysis after 120 patients were recruited. The study had to be interrupted after the interim analysis, due to an excess of strokes in the colchicine group: 5 cases versus 0, including 3 cases occurring early, in the first weeks following TAVI.
Analyzes of the primary endpoint and secondary endpoints on the 120 patients included, however, suggest that “the inflammatory pathway offers a potential therapeutic target to attenuate cardiac arrhythmias and thrombosis of the valve leaflets after TAVI”, underlines Thomas Pilgrim. Thus, the main criterion, which concerned the occurrence of de novo atrial fibrillation or conduction disorders requiring implantation of a permanent pacemaker at 30 days, was significantly reduced in the colchicine group, with an incidence of 10% compared to 25% in the placebo group.
Colchicine was also associated with a significant reduction in the incidence of at least a 50% reduction in mobility of at least one prosthetic valve leaflet or thickening of at least one prosthetic valve leaflet at 30 days (27.1% versus 54.2%).
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