BACKGROUND Colchicine has been approved to reduce cardiovascular risk in patients with coronary heart disease on the basis of its potential benefits demonstrated in the COLCOT (Colchicine Cardiovascular Outcomes Trial) and LoDoCo2 (Low-Dose Colchicine 2) studies. Nevertheless, there are limited data available about the specific impact of colchicine on coronary plaques. METHODS This was a prospective, single-center, randomized, double-blind clinical trial. From May 3, 2021, until August 31, 2022, a total of 128 patients with acute coronary syndrome aged 18 to 80 years with lipid-rich plaque (lipid pool arc >90°) detected by optical coherence tomography were included. The subjects were randomly assigned in a 1:1 ratio to receive either colchicine (0.5 mg once daily) or placebo for 12 months. The primary end point was the change in the minimal fibrous cap thickness from baseline to the 12-month follow-up. RESULTS Among 128 patients, 52 in the colchicine group and 52 in the placebo group completed the study. The mean age of the 128 patients was 58.0±9.8 years, and 25.0% were female. Compared with placebo, colchicine therapy significantly increased the minimal fibrous cap thickness (51.9 [95% CI, 32.8 to 71.0] μm versus 87.2 [95% CI, 69.9 to 104.5] μm; difference, 34.2 [95% CI, 9.7 to 58.6] μm; P=0.006), and reduced average lipid arc (-25.2° [95% CI, -30.6° to -19.9°] versus -35.7° [95% CI, -40.5° to -30.8°]; difference, -10.5° [95% CI, -17.7° to -3.4°]; P=0.004), mean angular extension of macrophages (-8.9° [95% CI, -13.3° to -4.6°] versus -14.0° [95% CI, -18.0° to -10.0°]; difference, -6.0° [95% CI, -11.8° to -0.2°]; P=0.044), high-sensitivity C-reactive protein level (geometric mean ratio, 0.6 [95% CI, 0.4 to 1.0] versus 0.3 [95% CI, 0.2 to 0.5]; difference, 0.5 [95% CI, 0.3 to 1.0]; P=0.046), interleukin-6 level (geometric mean ratio, 0.8 [95% CI, 0.6 to 1.1] versus 0.5 [95% CI, 0.4 to 0.7]; difference, 0.6 [95% CI, 0.4 to 0.9]; P=0.025), and myeloperoxidase level (geometric mean ratio, 1.0 [95% CI, 0.8 to 1.2] versus 0.8 [95% CI, 0.7 to 0.9]; difference, 0.8 [95% CI, 0.6 to 1.0]; P=0.047). CONCLUSIONS Our findings suggested that colchicine resulted in favorable effects on coronary plaque stabilization at optical coherence tomography in patients with acute coronary syndrome. REGISTRATION URL: https://www.clinicaltrials.gov; Unique identifier: NCT04848857.

中文翻译：

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通过光学相干断层扫描评估秋水仙碱对急性冠状动脉综合征冠状动脉斑块稳定性的影响：COLOCT 随机临床试验。


背景 秋水仙碱已被批准用于降低冠心病患者的心血管风险，因为其潜在益处已在 COLCOT（秋水仙碱心血管结果试验）和 LoDoCo2（低剂量秋水仙碱 2）研究中得到证明。然而，关于秋水仙碱对冠状动脉斑块的具体影响的可用数据有限。方法 这是一项前瞻性、单中心、随机、双盲临床试验。从 2021 年 5 月 3 日到 2022 年 8 月 31 日，共纳入 128 例年龄在 18 至 80 岁之间的急性冠脉综合征患者，通过光学相干断层扫描检测到富脂斑块（脂质池弧 >90°）。受试者以 1：1 的比例随机分配接受秋水仙碱（0.5 mg，每日一次）或安慰剂，持续 12 个月。主要终点是从基线到 12 个月随访的最小纤维帽厚度的变化。结果 在 128 例患者中，秋水仙碱组 52 例，安慰剂组 52 例完成了研究。128 例患者的平均年龄为 58.0±9.8 岁，其中 25.0% 为女性。与安慰剂相比，秋水仙碱治疗显著增加了最小纤维帽厚度（51.9 [95% CI，32.8 至 71.0] μm 对 87.2 [95% CI，69.9 至 104.5] μm;差异，34.2 [95% CI，9.7 至 58.6] μm;P=0.006）和平均血脂弧降低（-25.2° [95% CI，-30.6°-19.9°] vs -35.7° [95% CI，-40.5°-30.8°];差异，-10.5° [95% CI，-17.7°--3.4°];P=0.004）、巨噬细胞的平均角度延伸（-8.9° [95% CI，-13.3° 至 -4.6°] 对比 -14.0° [95% CI，-18.0° 至 -10.0°];差异，-6.0° [95% CI，-11.8° 至 -0.2°];P=0.044）、高敏 C 反应蛋白水平 （几何平均比值，0.6 [95% CI，0.4 至 1.0] 与 0.3 [95% CI，0.2 至 0.5];差异，0.5 [95% CI，0.3 至 1.0];P=0.046）、白细胞介素-6 水平（几何平均比值，0.8 [95% CI，0.6 至 1.1] 对比 0.5 [95% CI，0.4 至 0.7];差异，0.6 [95% CI，0.4 至 0.9];P=0.025）和髓过氧化物酶水平（几何平均比值，1.0 [95% CI，0.8 至 1.2] 对比 0.8 [95% CI，0.7 至 0.9];差异，0.8 [95% CI，0.6 至 1.0];P=0.047）。结论 我们的研究结果表明，秋水仙碱对急性冠脉综合征患者光学相干断层扫描的冠状动脉斑块稳定有良好的影响。注册网址：https://www.clinicaltrials.gov;唯一标识符：NCT04848857。