伴动脉粥样硬化的卒中后患者使用秋水仙碱的二级预防分析
在中位 33.6 个月随访中，意向治疗分析未显示秋水仙碱与动脉粥样硬化状态对主要不良心血管事件存在显著交互作用。但在动脉粥样硬化组的治疗中分析显示秋水仙碱显著降低主要不良心血管事件风险。
要点
- 动脉粥样硬化组意向治疗分析中，秋水仙碱组主要不良心血管事件数值上少于常规治疗组，但未达统计学显著。
- 治疗中分析显示，秋水仙碱可降低动脉粥样硬化患者主要不良心血管事件风险（HR 0.76）。
- 非动脉粥样硬化组未观察到秋水仙碱带来事件减少。
核心结论
- 意向治疗和治疗中分析均未显示秋水仙碱与动脉粥样硬化对主要不良心血管事件存在显著交互作用。
- 动脉粥样硬化患者分配至秋水仙碱组的事件数在数值上更少，且治疗中分析显示显著获益。
- 非动脉粥样硬化患者中未观察到秋水仙碱降低主要不良心血管事件风险。
研究设计与样本
- 本研究为 CONVINCE 试验的事后分析，CONVINCE 为随机、开放标签、盲终点评估设计。
- 比较秋水仙碱 0.5 mg 联合常规治疗与常规治疗，用于非心源性栓塞性卒中患者的血管炎症预防。
- 动脉粥样硬化定义为颈颅/主动脉斑块、冠心病、外周动脉疾病或颈动脉血运重建。
主要发现
- 随访期间共发生 338 例主要不良心血管事件。
- 动脉粥样硬化组中，秋水仙碱组事件为 105 例（11.1%），发病率为 3.88/100 人年（95%CI 3.21–4.70）。
- 动脉粥样硬化组中，常规治疗组事件为 132 例（14.2%），发病率为 4.83/100 人年（95%CI 4.07–5.73）。
- 动脉粥样硬化组意向治疗分析主要不良心血管事件 HR 为 0.83（95%CI 0.64–1.07）。
- 非动脉粥样硬化亚组主要结局 HR 为 0.94（95%CI 0.64–1.39），交互 P 值为 0.60。
关键数值与推荐
- 动脉粥样硬化定义为存在颈颅/主动脉斑块、冠心病、外周动脉疾病或颈动脉血运重建。
- 主要结局为主要不良心血管事件。
- 分析调整了年龄、入组事件、事件至随机化时间及冠心病。
临床怎么用
- 动脉粥样硬化性非心源性栓塞性卒中患者可能从秋水仙碱抗炎治疗中获得主要不良心血管事件方面的潜在获益。
- 当前意向治疗分析未见显著交互作用，提示动脉粥样硬化状态尚不能作为选择秋水仙碱治疗的确定性依据。
局限性
- 本研究为事后分析，亚组比较的统计学效能可能不足。
- 意向治疗与治疗中分析的交互检验均未达到统计学显著。
以上解读依据论文摘要（全文未开放获取或许可不允许翻译转载）。
原文
Stroke, Volume 57, Issue 10, Page 2981-2990, October 1, 2026. BACKGROUND:Anti-inflammatory therapies reduce the risk of major adverse cardiovascular events (MACEs) in coronary disease, but efficacy has not been shown after stroke. It is uncertain if patients with atherosclerosis are more likely to benefit from anti-inflammatory prevention.METHODS:We performed a post hoc analysis of the CONVINCE trial (randomized, open-label, blinded-end point assessed; Colchicine for Prevention of Vascular Inflammation in Non-Cardioembolic Stroke), comparing colchicine 0.5 mg plus usual care versus usual care. We performed a subgroup analysis in patients stratified according to the presence/absence of atherosclerosis (defined as cervico-cranial/aortic artery plaque, coronary disease, peripheral arterial disease, and carotid revascularization). The primary outcome was MACE. Analyses were adjusted for age, qualifying event, time from event to randomization, and coronary disease.RESULTS:Three thousand one hundred forty-four participants were included. There were 338 MACE events during follow-up (median, 33.6 months). On intention-to-treat analysis, there were numerically fewer MACE events in the atherosclerosis group assigned to colchicine (105 [11.1%], 3.88 [95% CI, 3.21–4.70] per 100 person-years) versus usual care (132 [14.2%], 4.83 [4.07–5.73] per 100 person-years), which was not statistically significant (hazard ratio [HR], 0.83 [95% CI, 0.64–1.07]). There was no difference in the rate of the primary outcome according to treatment allocation in the nonatherosclerosis subgroup (HR, 0.94 [95% CI, 0.64–1.39];Pinteraction=0.60). There was a nonsignificant reduced risk of recurrent ischemic stroke in the colchicine arm (HR, 0.76 [95% CI, 0.56–1.05]) in the atherosclerosis group, but no difference in events was observed in the nonatherosclerotic group (HR, 0.92 [95% CI, 0.60–1.42];Pinteraction=0.48). In the prespecified on-treatment analysis, colchicine reduced the risk of MACE in patients with atherosclerosis (HR, 0.76 [95% CI, 0.58–0.99]) but not without (HR, 0.95 [95% CI, 0.63–1.42];Pinteraction=0.37).CONCLUSIONS:There were no significant between-group interactions for colchicine and atherosclerosis for MACE in intention-to-treat or on-treatment populations. However, outcome events were numerically fewer in patients with atherosclerosis assigned to colchicine, and significant benefit was observed in the on-treatment analysis in this group. Data suggest that the presence of
引用
- Stroke：Colchicine for Secondary Prevention After Stroke According to the Presence of Atherosclerosis
供执业医师工作参考，不替代临床判断；数值与分级以指南原文为准。