The CONVINCE Trial: No Reduction in Recurrent Vascular Events with Long-Term Colchicine Use After Ischemic Stroke
Clinical question: Does long-term colchicine use plus guideline-based care after ischemic stroke prevent recurrent vascular events?
Background: According to the World Health Organization, stroke is the third leading cause of death worldwide. Prior studies in patients with coronary artery disease have shown that colchicine and other anti-inflammatory agents have helped to prevent recurrent events. Inflammation is known to be associated with initial and recurrent stroke events, but the use of colchicine has not yet been studied after stroke.
Study design: Prospective, randomized, open-label trial
Setting: 144 hospital sites across 13 European countries and Canada between December 19, 2016, and November 21, 2022
Synopsis: 3,154 patients above the age of 39 who had been diagnosed with non-severe ischemic stroke or high-risk transient ischemic attack (TIA) were randomized to receive colchicine 0.5 mg orally daily or no colchicine, plus guideline-based stroke care. Exclusion criteria included stroke or TIA due to atrial fibrillation or other cardioembolic cause, pre-existing diagnosis of moderate to severe renal, liver, or blood disorders, inflammatory bowel disease, and chronic diarrhea, among others. The primary composite endpoint was first recurrent, fatal, or non-fatal ischemic stroke, myocardial infarction, cardiac arrest, or hospitalization for unstable angina or vascular death within 30 days. Patients were followed for a median of 33.6 months. The primary endpoint occurred in 153 patients (9.8%) in the colchicine group and 185 patients (11.7%) in the standard care group (P=0.12). The adjusted hazard ratio was 0.84 (95% CI, 0.68–1.05; P=0.12). Rates of serious adverse events were similar in both groups. Due to the COVID-19 pandemic, the trial prematurely ended, resulting in fewer than the expected number of endpoints and a reduction in statistical power.
Bottom line: The Administration of colchicine after non-severe ischemic stroke or high-risk TIA did not result in a statistically significant reduction in recurrent vascular events.
Citation: Kelly P, et al. Long-term colchicine for the prevention of vascular recurrent events in non-cardioembolic stroke (CONVINCE): a randomized controlled trial. Lancet. 2024;404(10448):125-133. doi: 10.1016/S0140-6736(24)00968-1.
Dr. Herrman is an academic hospitalist at the University of California Davis Medical Center and a pre-clerkship clinical skills discipline co-lead at the UC Davis School of Medicine, both in Sacramento, Calif.