Author + information
- Received August 25, 2018
- Revision received September 9, 2018
- Accepted September 10, 2018
- Published online December 3, 2018.
- Thomas J. Ford, MBChB (Hons)a,b,c@TomJFord,
- Bethany Stanley, MScd,
- Richard Good, MDa,
- Paul Rocchiccioli, PhDa,b,
- Margaret McEntegart, PhDa,b,
- Stuart Watkins, MDa,
- Hany Eteiba, MDa,
- Aadil Shaukat, MBChBa,
- Mitchell Lindsay, MDa,
- Keith Robertson, PhDa,
- Stuart Hood, MDa,
- Ross McGeoch, MDe,
- Robert McDade, BSca,
- Eric Yiib,
- Novalia Sidik, MBChBb,
- Peter McCartney, MBChBb,
- David Corcoran, MBChBb,
- Damien Collison, MB BCha,b,
- Christopher Rush, MBChBb,
- Alex McConnachie, PhDd,
- Rhian M. Touyz, PhDb,
- Keith G. Oldroyd, MD (Hons)a,b and
- Colin Berry, PhDa,b,∗ (, )@UofGICAMS
- aWest of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, United Kingdom
- bBritish Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom
- cUniversity of New South Wales, Sydney, New South Wales, Australia
- dRobertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom
- eUniversity Hospital Hairmyres, East Kilbride, United Kingdom
- ↵∗Address for correspondence:
Dr. Colin Berry, British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, 126 University Place, University of Glasgow, Glasgow G12 8TA, Scotland, United Kingdom.
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)
- elective coronary angiography
- microvascular angina
- stable angina pectoris
- stratified medical therapy
- vasospastic angina
The CorMicA study was an investigator-initiated clinical trial that was funded by the British Heart Foundation (PG/17/2532884; RE/13/5/30177; RE/18/6/34217). No companies were involved in this study. The trial was sponsored by the Golden Jubilee Research Foundation. Dr. Ford was supported by the British Heart Foundation (PG/17/2532884; RE/13/5/30177). Dr. Rocchiccioli has received consultant and speaker fees from AstraZeneca. Dr. Watkins has received consultant and speaker fees from Boston Scientific. Dr. Touyz was supported by a British Heart Foundation Chair (CH/12/429762). Dr. Oldroyd has received consultant and speaker fees from Abbott Vascular, Boston Scientific, Biosensors, Opsens, and Philips, which manufacture diagnostic guidewires. Dr. Berry is employed by the University of Glasgow, which holds consultancy and research agreements with companies that have commercial interests in the diagnosis and treatment of angina, including Abbott Vascular, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Menarini Pharmaceuticals, Opsens, Philips, and Siemens Healthcare. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received August 25, 2018.
- Revision received September 9, 2018.
- Accepted September 10, 2018.
- 2018 American College of Cardiology Foundation
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