Stratified Medical Therapy Using Invasive Coronary Function Testing in Angina The CorMicA Trial

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

卷:72

Article

Ford, Thomas J.^1,2,3  Stanley, Bethany⁴  Good, Richard¹  Rocchiccioli, Paul^1,2  McEntegart, Margaret^1,2  Watkins, Stuart¹  Eteiba, Hany¹  Shaukat, Aadil¹  Lindsay, Mitchell¹  Robertson, Keith¹  Hood, Stuart¹  McGeoch, Ross⁵  McDade, Robert¹  Yii, Eric²  Sidik, Novalia²  McCartney, Peter²  Corcoran, David²  Collison, Damien^1,2  Rush, Christopher²  McConnachie, Alex⁴  Touyz, Rhian M.²  Oldroyd, Keith G.^1,2  Berry, Colin^1,2 

[1] Golden Jubilee Natl Hosp, West Scotland Heart & Lung Ctr, Clydebank, Scotland

[2] Univ Glasgow, Inst Cardiovasc & Med Sci, Glasgow Cardiovasc Res Ctr, British Heart Fdn, 126 Univ Pl, Glasgow G12 8TA, Lanark, Scotland

[3] Univ New South Wales, Sydney, NSW, Australia

[4] Univ Glasgow, Inst Hlth & Wellbeing, Robertson Ctr Biostat, Glasgow, Lanark, Scotland

[5] Univ Hosp Hairmyres, East Kilbride, Scotland

关键词: elective coronary angiography;    INOCA;    microvascular angina;    stable angina pectoris;    stratified medical therapy;    vasospastic angina;   

DOI  :  10.1016/j.jacc.2018.09.006

来源: Elsevier

【 摘 要 】

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.

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