Department of Cardiology, Peninsula Health, Melbourne, Victoria, Australia; Department of Medicine, Monash University, Melbourne, Victoria, Australia; Department of Cardiology, Royal Melbourne Hospital, Melbourne, Victoria, Australia.
Swinburne University of Technology, Department of Health Science and Biostatistics, Hawthorn, Victoria, Australia.
Cardiovasc Revasc Med. 2022 Nov;44:53-59. doi: 10.1016/j.carrev.2022.06.017. Epub 2022 Jun 18.
Recent data suggest that colchicine may reduce cardiovascular events among patients presenting with acute coronary syndromes. This sub-study of the Australian COPS trial aimed to assess whether colchicine affects health status outcomes.
Health status was assessed at baseline and 12-months using the EuroQol-5 Dimension 5-level (EQ-5D-5L) score and the full 19-question Seattle Angina Questionnaire (SAQ). Data were available for 786 patients (388 randomized to colchicine, 398 to placebo).
Baseline characteristics were well matched between groups; mean age was 60.1 (SD 14.8) years, and 20 % were female. Baseline health status scores were impaired, and most parameters demonstrated significant improvement from baseline to 12-months (EQ-5D-5L Visual Analogue Score [VAS] 69.3 to 77.7; SAQ angina frequency score 83.0 to 95.3, both p < 0.001). No significant differences in adjusted mean score change among any of the EQ-5D-5L or SAQ dimensions were observed between treatment groups in either intention-to-treat or per-protocol analysis. There were borderline interactions in EQ-5D-5L scores for those with previous MI vs not, and in SAQ scores for those with obesity vs not. In categorical analysis using observed data, patients treated with colchicine were more likely to have clinically significant improvement in physical limitation score over the period (36 % improved vs. 28 %, p < 0.05). Baseline health status scores were not associated with the primary endpoint at 12 months.
Treatment with colchicine did not appear to affect change in measures of health status following acute coronary syndromes, but it did lead to a greater likelihood of improvement in physical limitation scores.
ACTRN, ACTRN12615000861550. Registered 18/08/2015, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368973.
最近的数据表明，秋水仙碱可能会降低急性冠脉综合征患者的心血管事件发生率。本项澳大利亚 COPS 试验的亚组研究旨在评估秋水仙碱是否会影响健康状况的结果。
使用 EuroQol-5 维度 5 级量表（EQ-5D-5L）评分和完整的西雅图心绞痛问卷（SAQ），在基线和 12 个月时评估健康状况。共有 786 名患者（388 名随机分配至秋水仙碱组，398 名分配至安慰剂组）的数据可用。
两组间的基线特征匹配良好；平均年龄为 60.1（14.8）岁，20%为女性。基线健康状况评分较差，大多数参数从基线到 12 个月时均有显著改善（EQ-5D-5L 视觉模拟评分从 69.3 提高至 77.7；SAQ 心绞痛发作频率评分从 83.0 提高至 95.3，均 p<0.001）。在意向治疗或符合方案分析中，在任何 EQ-5D-5L 或 SAQ 维度的调整平均评分变化方面，治疗组之间均无显著差异。在既往心肌梗死与非心肌梗死患者之间的 EQ-5D-5L 评分，以及肥胖与非肥胖患者之间的 SAQ 评分方面，观察到边缘交互作用。在使用观察数据的分类分析中，在研究期间，接受秋水仙碱治疗的患者在身体受限评分方面更有可能出现临床显著改善（36%的患者改善，28%的患者未改善，p<0.05）。基线健康状况评分与 12 个月时的主要终点无关。
急性冠脉综合征后，秋水仙碱治疗似乎不会影响健康状况测量值的变化，但确实增加了身体受限评分改善的可能性。
ACTRN，ACTRN12615000861550。注册于 2015 年 8 月 18 日，https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368973。
