Author + information
- Received August 25, 2018
- Revision received September 9, 2018
- Accepted September 10, 2018
- Published online September 25, 2018.
- Thomas J. Ford, MBChB (Hons), FRACP1,2,3,
- Bethany Stanley, MSc5,
- Richard Good, MD1,
- Paul Rocchiccioli, PhD1,2,
- Margaret McEntegart, PhD1,2,
- Stuart Watkins, MD1,
- Hany Eteiba, MD1,
- Aadil Shaukat, FRCP1,
- Mitchell Lindsay, MD1,
- Keith Robertson, MD1,
- Stuart Hood, MD1,
- Ross McGeoch, MD4,
- Robert McDade1,
- Eric Yii2,
- Novalia Sidik, MBChB2,
- Peter McCartney, MBChB2,
- David Corcoran, MBChB2,
- Damien Collison, MB BCh1,2,
- Christopher Rush, MBChB2,
- Alex McConnachie, PhD5,
- Rhian M. Touyz, PhD2,
- Keith G. Oldroyd, MD(Hons)1,2 and
- Colin Berry, PhD1,2,∗ (, )@TomJFord@UofGICAMS
- 1West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, UK
- 2British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, UK
- 3University of New South Wales, Sydney, Australia
- 4University Hospital Hairmyres, East Kilbride, UK
- 5Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow
- ↵∗Correspondence: Colin Berry, PhD British Heart Foundation Glasgow Cardiovascular Research Centre Institute of Cardiovascular and Medical Sciences 126 University Place, University of Glasgow Glasgow, G12 8TA, Scotland, UK Telephone: +44 (0) 141 330 3325 or +44 (0) 141 951 5180 Fax +44 (0) 141 330 6794.
Background Angina without obstructive epicardial coronary artery disease (CAD) is a common problem with distinct underlying causes.
Objective To test the hypothesis that stratified medical therapy guided by an interventional diagnostic procedure (IDP) improves patient outcomes.
Methods We conducted a randomized, controlled, blinded clinical trial of stratified medical therapy versus standard care in patients with angina. We recruited patients with angina undergoing invasive coronary angiography (standard care). 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). Vasoreactivity testing was performed by infusing incremental concentrations of acetylcholine (ACh) followed by a bolus vasospasm provocation (<100μg). The primary endpoint was the mean difference in angina severity at 6 months (assessed by the Seattle Angina Questionnaire summary score).
Results 391 patients were enrolled between 25/11/2016-11/12/2017. Coronary angiography revealed obstructive disease in 206 (53.7%). 151 (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 units in the SAQSS at 6 months (95%CI: 5.0-18.4; p = 0.001). In addition, the intervention led to improvements in the mean quality of life score (EQ5D index 0.10 units; 0.01-0.18; p = 0.024) and visual analogue score (14.5 units; 7.8-21.3; p <0.001). There were no differences in major adverse cardiac events (MACE) at the 6 month follow up (2.6% controls v 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.
- Stratified medical therapy
- stable angina pectoris
- elective coronary angiography
- microvascular angina
- vasospastic angina
Conflicts of interest: C.B. 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. The companies include Abbott Vascular, AstraZeneca, Boehringer Ingelheim, GSK, Menarini Pharmaceuticals, Opsens, Philips, and Siemens Healthcare. K.G.O. has received consultant and speaker fees from Abbott Vascular, Boston Scientific, Opsens and Philips which manufacture diagnostic guidewires. S.W. has received consultant and speaker fees from Boston Scientific. P.R. has received consultant and speaker fees from Astra Zeneca.None of these companies have had any involvement with this study. None of the other authors have any potential conflicts of interest.
Funding: The CorMicA study was an investigator-initiated clinical trial that was funded by the British Heart Foundation (PG/17/2532884; RE/13/5/30177). No companies are involved in this study. The trial was sponsored by the Golden Jubilee Research Foundation. The authors are solely responsible for the design and conduct of the study, all analyses, the drafting and editing of the paper and its final contents.
Ethics & Declaration of Helsinki: The BHF CorMicA trial complied with the Declaration of Helsinki and had full UK National Research Ethics Service approval (Reference 16/WS/0192). Informed consent was obtained from all of the participants.
- Received August 25, 2018.
- Revision received September 9, 2018.
- Accepted September 10, 2018.
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