Stratified Medical Therapy Using Invasive Coronary Function Testing in Angina The CorMicA Trial
Stratified Medical Therapy Using Invasive Coronary Function Testing in Angina The CorMicA Trial
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DOI：
10.1016/j.jacc.2018.09.006
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发表时间：
2018-12-11
影响因子：
24
通讯作者：
Berry, Colin
中科院分区：
文献类型：
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作者：
Ford, Thomas J.;Stanley, Bethany;Berry, Colin
有心绞痛症状和/或缺血体征但无阻塞性冠状动脉疾病（INOCA）的患者提出了诊断和治疗的挑战。结论本研究的目的是测试与分层药物相关的介入诊断程序（IDP）是否改善了INOCA患者的健康状况。心绞痛患者分层药物治疗与标准治疗的盲法临床试验。招募接受侵入性冠状动脉造影（标准治疗）的心绞痛患者。无阻塞性CAD的患者立即按1：1随机分配至干预组（分层药物治疗）或对照组（标准治疗，IDP假手术）。IDP包括基于导丝的冠状动脉血流储备、微循环阻力指数、血流储备分数的评估，然后用乙酰胆碱进行血管反应性测试。主要终点是6个月时心绞痛严重程度的平均差异（通过西雅图心绞痛问卷总结评分评估）。结果2016年11月25日至2017年11月12日期间，共招募了391例患者。冠状动脉造影显示阻塞性病变206例（53.7%）。151例（39%）无血管造影阻塞性CAD的患者被随机分组（n = 76干预组; n = 75设盲对照组）。干预导致6个月时西雅图心绞痛问卷总分平均改善11.7 U（95%置信区间[CI]：5.0 - 18.4; p = 0.001）。此外，干预导致平均生活质量评分（EQ-5D指数0.10 U; 95% CI：0.01至0.18; p = 0.024）和视觉模拟评分（14.5 U; 95% CI：7.8至21.3; p < 0.001）改善。在6个月的随访中，主要不良心脏事件没有差异（对照组2.6%对干预组2.6%; p = 1.00）。结论冠状动脉造影术通常不能识别血管痉挛和/或微血管性心绞痛患者。分层药物治疗，包括IDP与联合药物治疗，是常规可行的，并改善无阻塞性CAD患者的心绞痛。（冠状动脉微血管性心绞痛[CorMicA]; NCT 03193294）（c）2018年美国心脏病学会基金会。
BACKGROUND Patients with angina symptoms and/or signs of ischemia but no obstructive coronary artery disease (INOCA) pose a diagnostic and therapeutic challenge.OBJECTIVES The purpose of this study was to test whether an interventional diagnostic procedure (IDP) linked to stratified medicine improves health status in patients with INOCA.METHODS The authors conducted a randomized, controlled, blinded clinical trial of stratified medical therapy versus standard care in patients with angina. Patients with angina undergoing invasive coronary angiography (standard care) were recruited. Patients without obstructive CAD were immediately randomized 1: 1 to the intervention group (stratified medical therapy) or the control group (standard care, IDP sham procedure). The IDP consisted of guidewire-based assessment of coronary flow reserve, index of microcirculatory resistance, fractional flow reserve, followed by vasoreactivity testing with acetylcholine. The primary endpoint was the mean difference in angina severity at 6 months (assessed by the Seattle Angina Questionnaire summary score).RESULTS A total of 391 patients were enrolled between November 25, 2016, and November 12, 2017. Coronary angiography revealed obstructive disease in 206 (53.7%). One hundred fifty-one (39%) patients without angiographically obstructive CAD were randomized (n = 76 intervention group; n = 75 blinded control group). The intervention resulted in a mean improvement of 11.7 U in the Seattle Angina Questionnaire summary score at 6 months (95% confidence interval [CI]: 5.0 to 18.4; p = 0.001). In addition, the intervention led to improvements in the mean quality-of-life score (EQ-5D index 0.10 U; 95% CI: 0.01 to 0.18; p = 0.024) and visual analogue score (14.5 U; 95% CI: 7.8 to 21.3; p < 0.001). There were no differences in major adverse cardiac events at the 6-month follow-up (2.6% controls vs. 2.6% intervention; p = 1.00).CONCLUSIONS Coronary angiography often fails to identify patients with vasospastic and/or microvascular angina. Stratified medical therapy, including an IDP with linked medical therapy, is routinely feasible and improves angina in patients with no obstructive CAD. (CORonary MICrovascular Angina [CorMicA]; NCT03193294) (c) 2018 by the American College of Cardiology Foundation.