Key result
Guided stratified medical therapy improves 6-month angina severity by ~12 points over standard care.
Why the study?
Angina without obstructive epicardial coronary artery disease is common and has distinct underlying causes that are not identified by coronary angiography alone.
Does stratified medical therapy guided by invasive coronary function testing improve angina severity in patients with angina without obstructive coronary artery disease?
RCT (n=151)
Blinded
1:1
Does stratified medical therapy guided by invasive coronary function testing improve angina severity in patients with angina without obstructive coronary artery disease?
Mean Difference: 11.7 (95% CI 5–18.4)
p-value: p=0.001
Stratified medical therapy guided by invasive coronary function testing significantly improves angina severity and quality of life in patients with angina and no obstructive coronary artery disease.
Ford, T. J. et al. (2018) Stratified medical therapy using invasive coronary function testing in angina: CorMicA trial. Journal of the American College of Cardiology , 72(23 PtA), pp. 2841-2855. (doi: 10.1016/j.jacc.2018.09.006 ) (PMID: 30266608 ) Full text not currently available from Enlighten. Background: Angina without obstructive epicardial coronary artery disease (CAD) is a common problem with distinct underlying causes. Objectives: The purpose of this study was to test the hypothesis that stratified medical therapy guided by an interventional diagnostic procedure (IDP) improves patient outcomes. 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). Vasoreactivity testing was performed by infusing incremental concentrations of acetylcholine (ACh) followed by a bolus vasospasm provocation (≤100 μg). 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%). A total of 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 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 (EQ5D index 0.10 units; 95% CI: 0.01 to 0.18; p = 0.024) and visual analogue score (14.5 units; 95% CI: 7.8 to 21.3; p < 0.001). There were no differences in major adverse cardiac events (MACE) 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) University Staff: Request a correction | Enlighten Editors: Update this record
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Ford et al. (2018) conducted an RCT in Angina without obstructive epicardial coronary artery disease (n=151). Stratified medical therapy guided by an interventional diagnostic procedure (IDP) vs. Standard care with IDP sham procedure was evaluated on Mean difference in angina severity at 6 months (assessed by the Seattle Angina Questionnaire summary score) (MD 11.7, 95% CI 5.0 to 18.4, p=0.001). Stratified medical therapy guided by an interventional diagnostic procedure improved angina severity at 6 months compared to standard care (mean difference 11.7 units; 95% CI 5.0-18.4; P=0.001).
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