West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, United Kingdom; British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom; Gosford Hospital, NSW Health, Gosford, Australia.
Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom.
JACC Cardiovasc Interv. 2020 Jan 13;13(1):33-45. doi: 10.1016/j.jcin.2019.11.001. Epub 2019 Nov 11.
The aim of this study was to test the hypothesis that invasive coronary function testing at time of angiography could help stratify management of angina patients without obstructive coronary artery disease.
Medical therapy for angina guided by invasive coronary vascular function testing holds promise, but the longer-term effects on quality of life and clinical events are unknown among patients without obstructive disease.
A total of 151 patients with angina with symptoms and/or signs of ischemia and no obstructive coronary artery disease were randomized to stratified medical therapy guided by an interventional diagnostic procedure versus standard care (control group with blinded interventional diagnostic procedure results). The interventional diagnostic procedure-facilitated diagnosis (microvascular angina, vasospastic angina, both, or neither) was linked to guideline-based management. Pre-specified endpoints included 1-year patient-reported outcome measures (Seattle Angina Questionnaire, quality of life [EQ-5D]) and major adverse cardiac events (all-cause mortality, myocardial infarction, unstable angina hospitalization or revascularization, heart failure hospitalization, and cerebrovascular event) at subsequent follow-up.
Between November 2016 and December 2017, 151 patients with ischemia and no obstructive coronary artery disease were randomized (n = 75 to the intervention group, n = 76 to the control group). At 1 year, overall angina (Seattle Angina Questionnaire summary score) improved in the intervention group by 27% (difference 13.6 units; 95% confidence interval: 7.3 to 19.9; p < 0.001). Quality of life (EQ-5D index) improved in the intervention group relative to the control group (mean difference 0.11 units [18%]; 95% confidence interval: 0.03 to 0.19; p = 0.010). After a median follow-up duration of 19 months (interquartile range: 16 to 22 months), major adverse cardiac events were similar between the groups, occurring in 9 subjects (12%) in the intervention group and 8 (11%) in the control group (p = 0.803).
Stratified medical therapy in patients with ischemia and no obstructive coronary artery disease leads to marked and sustained angina improvement and better quality of life at 1 year following invasive coronary angiography. (Coronary Microvascular Angina [CorMicA]; NCT03193294).
本研究旨在验证这样一个假设，即在进行血管造影时进行有创冠状动脉功能检查有助于对无阻塞性冠状动脉疾病的心绞痛患者进行分层管理。
基于有创冠状动脉血管功能检查的心绞痛医疗治疗前景广阔，但在无阻塞性疾病的患者中，其对生活质量和临床事件的长期影响尚不清楚。
共 151 名有症状和/或有缺血迹象且无阻塞性冠状动脉疾病的心绞痛患者随机分为分层药物治疗组和标准治疗组（对照组，行有创诊断程序但结果设盲）。有创诊断程序辅助诊断（微血管性心绞痛、痉挛性心绞痛、二者兼有或均无）与基于指南的管理相关联。主要终点包括 1 年时患者报告的结果测量指标（西雅图心绞痛问卷、生活质量[EQ-5D]）和随后随访时的主要不良心脏事件（全因死亡率、心肌梗死、不稳定型心绞痛住院或血运重建、心力衰竭住院和脑血管事件）。
2016 年 11 月至 2017 年 12 月，151 名有缺血但无阻塞性冠状动脉疾病的患者被随机分组（干预组 75 例，对照组 76 例）。在 1 年时，干预组的总体心绞痛（西雅图心绞痛问卷综合评分）改善了 27%（差值 13.6 个单位；95%置信区间：7.3 至 19.9；p<0.001）。与对照组相比，干预组的生活质量（EQ-5D 指数）也有所改善（平均差值 0.11 个单位[18%]；95%置信区间：0.03 至 0.19；p=0.010）。在中位随访 19 个月（四分位距：16 至 22 个月）后，两组间主要不良心脏事件相似，干预组有 9 例（12%）和对照组有 8 例（11%）发生（p=0.803）。
在有缺血和无阻塞性冠状动脉疾病的患者中进行分层药物治疗可导致有创冠状动脉造影后 1 年时显著且持续的心绞痛改善和更好的生活质量。（冠状动脉微血管性心绞痛[CorMicA]；NCT03193294）。
