St Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia (D.C.T., R.W., A.W., J.L.).
Cardiology, Department of Medicine, Peninsula Health, Frankston, Victoria, Australia (D.C.T., R.S., N.M.H., J.L.).
Circulation. 2020 Nov 17;142(20):1890-1900. doi: 10.1161/CIRCULATIONAHA.120.050771. Epub 2020 Aug 29.
Inflammation plays a crucial role in clinical manifestations and complications of acute coronary syndromes (ACS). Colchicine, a commonly used treatment for gout, has recently emerged as a novel therapeutic option in cardiovascular medicine owing to its anti-inflammatory properties. We sought to determine the potential usefulness of colchicine treatment in patients with ACS.
This was a multicenter, randomized, double-blind, placebo-controlled trial involving 17 hospitals in Australia that provide acute cardiac care service. Eligible participants were adults (18-85 years) who presented with ACS and had evidence of coronary artery disease on coronary angiography managed with either percutaneous coronary intervention or medical therapy. Patients were assigned to receive either colchicine (0.5 mg twice daily for the first month, then 0.5 mg daily for 11 months) or placebo, in addition to standard secondary prevention pharmacotherapy, and were followed up for a minimum of 12 months. The primary outcome was a composite of all-cause mortality, ACS, ischemia-driven (unplanned) urgent revascularization, and noncardioembolic ischemic stroke in a time to event analysis.
A total of 795 patients were recruited between December 2015 and September 2018 (mean age, 59.8±10.3 years; 21% female), with 396 assigned to the colchicine group and 399 to the placebo group. Over the 12-month follow-up, there were 24 events in the colchicine group compared with 38 events in the placebo group (=0.09, log-rank). There was a higher rate of total death (8 versus 1; =0.017, log-rank) and, in particular, noncardiovascular death in the colchicine group (5 versus 0; =0.024, log-rank). The rates of reported adverse effects were not different (colchicine 23.0% versus placebo 24.3%), and they were predominantly gastrointestinal symptoms (colchicine, 23.0% versus placebo, 20.8%).
The addition of colchicine to standard medical therapy did not significantly affect cardiovascular outcomes at 12 months in patients with ACS and was associated with a higher rate of mortality. Registration: URL: https://www.anzctr.org.au; Unique identifier: ACTRN12615000861550.
炎症在急性冠状动脉综合征（ACS）的临床表现和并发症中起着至关重要的作用。秋水仙碱是一种常用于治疗痛风的药物，由于其抗炎特性，最近在心血管医学中成为一种新的治疗选择。我们旨在确定秋水仙碱治疗 ACS 患者的潜在益处。
这是一项多中心、随机、双盲、安慰剂对照试验，涉及澳大利亚 17 家提供急性心脏护理服务的医院。符合条件的参与者为成年（18-85 岁）ACS 患者，经冠状动脉造影证实患有冠状动脉疾病，接受经皮冠状动脉介入治疗或药物治疗。患者被分配接受秋水仙碱（第一个月每天两次 0.5mg，然后每天 0.5mg，持续 11 个月）或安慰剂，此外还接受标准二级预防药物治疗，并随访至少 12 个月。主要结局是时间事件分析中的全因死亡率、ACS、缺血驱动（计划外）紧急血运重建和非心源性缺血性卒中的复合终点。
2015 年 12 月至 2018 年 9 月期间共招募了 795 名患者（平均年龄 59.8±10.3 岁；21%为女性），其中 396 名患者被分配到秋水仙碱组，399 名患者被分配到安慰剂组。在 12 个月的随访中，秋水仙碱组有 24 例事件，安慰剂组有 38 例事件（=0.09，对数秩检验）。秋水仙碱组的总死亡率较高（8 例比 1 例；=0.017，对数秩检验），尤其是非心血管死亡率（5 例比 0 例；=0.024，对数秩检验）。报告的不良反应发生率无差异（秋水仙碱组 23.0%，安慰剂组 24.3%），主要为胃肠道症状（秋水仙碱组 23.0%，安慰剂组 20.8%）。
在 ACS 患者中，秋水仙碱联合标准药物治疗在 12 个月时并未显著影响心血管结局，反而与更高的死亡率相关。注册：网址：https://www.anzctr.org.au；唯一标识符：ACTRN12615000861550。
