秋水仙碱预防经皮冠状动脉介入治疗围术期心肌损伤（COPE-PCI）：冠状动脉微血管生理学先导子研究。
COlchicine to Prevent PeriprocEdural Myocardial Injury in Percutaneous Coronary Intervention (COPE-PCI): Coronary Microvascular Physiology Pilot Substudy.
机构信息
Peninsula Heart Service, Peninsula Health, Frankston, Australia.
Peninsula Clinical School, Monash University, Melbourne, Australia.
出版信息
J Interv Cardiol. 2022 May 29;2022:1098429. doi: 10.1155/2022/1098429. eCollection 2022.
AIM
In this randomized pilot trial, we aimed to assess the anti-inflammatory effect of preprocedural colchicine on coronary microvascular physiology measurements before and after PCI.
METHODS
Patients undergoing PCI for stable angina (SA) or non-ST-elevation myocardial infarction (NSTEMI) were randomized to oral colchicine or placebo, 6- to 24-hours before the procedure. Strict prespecified inclusion/exclusion criteria were set to ensure all patients were given the study medication, had a PCI, and had pre- and post-PCI culprit vessel invasive coronary physiology measurements. Fractional flow reserve (FFR), Index of Microvascular Resistance (IMR), Coronary Flow Reserve (CFR), and Resistive Reserve Ratio (RRR) were measured immediately before and after PCI. CMVD was defined as any one of post-PCI IMR >32 or CFR <2 or RRR <2. High-sensitive-(hs)-troponin-I, hsCRP, and leucocyte count were measured before and 24 hours after PCI.
RESULTS
A total of 50 patients were randomized and met the strict prespecified inclusion/exclusion criteria: 24-colchicine and 26-placebo. Pre-PCI coronary physiology measurements, hs-troponin-I, and hsCRP were similar between groups. Although numerically lower in patients given colchicine, the proportion of patients who developed CMVD was not significantly different between groups (colchicine: 10 (42%) vs placebo: 16 (62%), =0.16). Colchicine patients had higher post-PCI CFR and RRR vs placebo (respectively: 3.25 vs 2.00, =0.03 & 4.25 vs 2.75, < 0.01). Neutrophil count was lower after PCI in the colchicine arm (=0.02), and hsCRP post-PCI remained low in both treatment arms (1.0 mg/L vs 1.7 mg/L, =0.97). Patients randomized to colchicine had significantly less PCI-related absolute hs-troponin-I change (46 ng/L vs 152 ng/L, =0.01).
CONCLUSION
In this pilot randomized substudy, colchicine given 6 to 24 hours before PCI did not statistically impact the post-PCI CMVD definition used in this study, yet it did improve post-PCI RRR and CFR measurements, with less procedure-related troponin release and less inflammation.
目的
在这项随机试验中，我们旨在评估 PCI 前和后预处理秋水仙碱对冠状动脉微血管生理测量的抗炎作用。
方法
接受稳定型心绞痛（SA）或非 ST 段抬高型心肌梗死（NSTEMI）PCI 的患者，随机接受口服秋水仙碱或安慰剂，在手术前 6 至 24 小时。严格规定了纳入/排除标准，以确保所有患者都接受了研究药物治疗，进行了 PCI 治疗，并进行了 PCI 前后罪犯血管有创性冠状动脉生理测量。测量即刻在 PCI 前后分别测量了血流储备分数（FFR）、微血管阻力指数（IMR）、冠状动脉血流储备（CFR）和阻力储备比（RRR）。CMVD 的定义为 PCI 后 IMR >32 或 CFR <2 或 RRR <2 中的任何一项。在 PCI 前后 24 小时测量高敏肌钙蛋白 I（hs-troponin-I）、hsCRP 和白细胞计数。
结果
共有 50 名患者被随机分组，并符合严格的纳入/排除标准：24 名秋水仙碱和 26 名安慰剂。PCI 前的冠状动脉生理测量、hs-troponin-I 和 hsCRP 在两组之间相似。虽然秋水仙碱组的患者比例较低，但两组之间发生 CMVD 的患者比例无显著差异（秋水仙碱组：10 例（42%）vs 安慰剂组：16 例（62%），=0.16）。与安慰剂相比，秋水仙碱组患者的 PCI 后 CFR 和 RRR 更高（分别为：3.25 对 2.00，=0.03 和 4.25 对 2.75， < 0.01）。秋水仙碱组的中性粒细胞计数在 PCI 后较低（=0.02），且两组的 hsCRP 在 PCI 后均较低（1.0mg/L 对 1.7mg/L，=0.97）。与安慰剂相比，随机给予秋水仙碱的患者 PCI 相关的 hs-troponin-I 变化绝对值明显减少（46ng/L 对 152ng/L，=0.01）。
结论
在这项随机亚研究中，PCI 前 6 至 24 小时给予秋水仙碱在统计学上并没有影响该研究中使用的 PCI 后 CMVD 定义，但它确实改善了 PCI 后 RRR 和 CFR 的测量值，同时减少了与操作相关的肌钙蛋白释放和炎症。
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