Title Validation of the SMART-REACH model after stroke and the effect of colchicine by atherosclerotic cardiovascular disease risk category: a secondary analysis of the CONVINCE randomised clinical trial
Authors Maes, Louise ; Verschuere, Claudia ; Walsh, Cathal ; Weimar, Christian ; Purroy, Francisco ; Price, Christopher ; Fonseca, Catarina ; Hill, Michael D ; Jatužis, Dalius ; Kõrv, Janika ; Kruuse, Christina ; Mikulik, Robert ; Nederkoorn, Paul ; Czlonkowska, Anna ; Fischer, Urs ; McCormick, Michael ; Castellanos, Maria ; Baptista, Miguel ; Marto, João Pedro ; Thavanesan, Kamy ; Williams, David J ; Kelly, Peter ; Lemmens, Robin
DOI 10.1093/esj/aakag033
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Is Part of European stroke journal.. Oxford : Oxford University Press. 2026, vol. 11, iss. 4, art. no. aakag033, p. [1-11].. ISSN 2396-9873. eISSN 2396-9881
Keywords [eng] atherosclerotic cardiovascular disease ; colchicine ; risk estimation ; risk factors ; secondary prevention ; stroke ; transient ischaemic attack
Abstract [eng] Introduction: The Colchicine for prevention of vascular inflammation in Non-CardioEmbolic stroke (CONVINCE) trial showed that recurrent events were significantly reduced among colchicine-adherent non-cardioembolic stroke patients in the on-treatment analysis. This study aimed to validate the SMART-REACH risk score in stroke patients, and to determine whether colchicine's efficacy varies by baseline atherosclerotic cardiovascular disease (ASCVD) risk. Patients and methods: Patients with non-severe non-cardioembolic ischaemic stroke/transient ischaemic attack (TIA) were randomised to colchicine 0.5 mg plus usual care or usual care alone. Participants were stratified into moderate (10%-19%), high (20%-30%) and very high (≥30%) 10-year ASCVD risk categories using the SMART-REACH model. Model performance was assessed using the C-statistic and calibration plots. The primary endpoint (major adverse cardiovascular events [MACE]) was a composite of fatal or non-fatal recurrent ischaemic stroke, myocardial infarction, cardiac arrest or hospitalisation for unstable angina. Results: Among 3144 patients, MACE incidence significantly increased with ASCVD risk levels: 7.2% (moderate), 8.8% (high) and 13.8% (very high) (P < .01). The C-statistic for 3-year risk of MACE was 0.59 (95% CI, 0.56-0.63). While no statistically significant treatment interaction was found (P = .88), absolute risk reductions (ARRs) were more pronounced in higher-risk groups: moderate risk 7.2% (colchicine) vs 7.2% (usual care) (hazard ratio [HR] 1.01; 95% CI, 0.55-1.83); high risk 7.7% vs 9.8% (ARR 2.1%; HR 0.79; 95% CI, 0.53-1.18); very high risk 12.5% vs 15.2% (ARR 2.7%; HR 0.85; 95% CI, 0.64-1.12). Discussion and conclusion: We identified an association between very high baseline ASCVD risk (≥30%) assigned by the SMART-REACH score and increased recurrent MACE. Although no significant treatment interaction was observed, patients in higher risk categories may represent a more promising target population for secondary prevention with colchicine.
Published Oxford : Oxford University Press
Type Journal article
Language English
Publication date 2026
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