Effect of colchicine for secondary prevention according to stroke subtype: A secondary analysis of the CONVINCE randomized trial.

IF 6.9 2区医学 Q1 CLINICAL NEUROLOGY

International Journal of Stroke Pub Date : 2026-08-01 Epub Date: 2025-12-02 DOI:10.1177/17474930251406818

Louise Maes, Cathal Walsh, Christian Weimar, Francisco Purroy, Christopher Price, Brian Clarke, Pedro Castro, Anna Czlonkowska, Elisa Cuadrado-Godia, Urs Fischer, Ana Catarina Fonseca, Michael D Hill, Dalius Jatuzis, Janika Kõrv, Christina Kruuse, Robert Mikulik, Paul J Nederkoorn, Laszlo Sztriha, Marcus Thieme, Peter Kelly, Robin Lemmens

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引用次数: 0

Abstract

Background: The Colchicine for prevention of vascular inflammation in Non-CardioEmbolic stroke (CONVINCE) trial evaluated long-term treatment with colchicine for the prevention of major adverse cardiovascular events (MACE) in a stroke population. Although the intention-to-treat analysis did not demonstrate a significant reduction in the primary endpoint, fewer outcome events were observed in the colchicine-treated group. It is unknown if a potential treatment effect is modified by ischemic stroke etiology.

Aims: In this pre-specified secondary analysis, we aimed to evaluate the efficacy of colchicine for prevention of MACE in patients with minor stroke or high-risk transient ischemic attack (TIA) according to index event stroke etiology.

Methods: A total of 3154 patients with recent non-cardioembolic stroke or TIA were randomly assigned to receive colchicine, 0.5 mg daily in addition to guideline-based usual care or usual care alone. The primary endpoint was a composite of first fatal or non-fatal recurrent ischemic stroke, myocardial infarction, cardiac arrest, or hospitalization for unstable angina. Subgroups of patients with large-artery atherosclerosis, small-vessel disease, and cryptogenic stroke were evaluated.

Results: A total of 3100 patients were included in the current analysis. The treatment effect did not vary across stroke subtype subgroups (p = 0.64 for interaction). In patients allocated to colchicine versus usual care alone, the primary endpoint occurred in 32 of 260 (12.3%) versus 42 of 263 (16%) patients with large-artery atherosclerosis (hazard ratio (HR), 0.77 (95% CI, 0.48-1.22)); 39 of 419 (9.3%) versus 47 of 435 (10.8%) patients with small-vessel occlusion (HR, 0.87 (95% CI, 0.57-1.34)); and 82 of 877 (9.4%) versus 92 of 846 (10.5%) patients with cryptogenic stroke (HR, 0.89 (95% CI, 0.66-1.12)).

Conclusions: The direction of effect for prevention of recurrent MACE favored colchicine, consistent with randomized trials in coronary disease, regardless of stroke subtype. Future stroke trials should consider selecting patients with evidence of atherosclerosis irrespective of stroke subtype.

Trial registration: ClinicalTrials.gov Identifier: NCT02898610.

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秋水仙碱对脑卒中亚型的二级预防作用——对卒中随机试验的二次分析。

研究背景：秋水仙碱预防非心源性卒中血管炎症（CONVINCE）试验评估了长期使用秋水仙碱预防卒中人群主要不良心血管事件（MACE）的效果。虽然意向治疗分析没有显示主要终点的显著减少，但秋水仙碱治疗组观察到的结局事件较少。目前尚不清楚潜在的治疗效果是否会受到缺血性卒中病因的影响。目的：在这项预先指定的次要分析中，我们旨在评估秋水仙碱在轻度卒中或高风险短暂性脑缺血发作（TIA）患者中预防MACE的疗效。方法将3154例近期发生非心源性卒中或TIA的患者随机分配到秋水仙碱组，每日0.5 mg，同时给予基于指南的常规治疗或单独常规治疗。主要终点是首次致死性或非致死性复发性缺血性卒中、心肌梗死、心脏骤停或因不稳定心绞痛住院的综合结果。对大动脉粥样硬化、小血管疾病和隐源性卒中患者的亚组进行评估。结果本次分析共纳入3100例患者。治疗效果在不同脑卒中亚型亚组间无差异（相互作用P = 0.64）。在分配给秋水仙碱与常规治疗的患者中，260例大动脉粥样硬化患者中有32例（12.3%）出现主要终点，263例中有42例（16%）出现主要终点（风险比[HR]， 0.77 [95% CI, 0.48-1.22]）；419例中有39例（9.3%），435例中有47例（10.8%）存在小血管闭塞（HR, 0.87 [95% CI, 0.57-1.34]）；877例隐源性卒中患者中有82例（9.4%）vs 846例中有92例（10.5%）（HR, 0.89 [95% CI, 0.66-1.12]）。结论秋水仙碱在预防MACE复发中的作用方向偏向于秋水仙碱，与冠状动脉疾病的随机试验结果一致，与卒中亚型无关。未来的卒中试验应考虑选择有动脉粥样硬化证据的患者，而不考虑卒中亚型。临床试验注册号：NCT02898610。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

International Journal of Stroke 医学-外周血管病

CiteScore

13.90

自引率

6.00%

发文量

132

审稿时长

6-12 weeks

期刊介绍： The International Journal of Stroke is a welcome addition to the international stroke journal landscape in that it concentrates on the clinical aspects of stroke with basic science contributions in areas of clinical interest. Reviews of current topics are broadly based to encompass not only recent advances of global interest but also those which may be more important in certain regions and the journal regularly features items of news interest from all parts of the world. To facilitate the international nature of the journal, our Associate Editors from Europe, Asia, North America and South America coordinate segments of the journal.