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A Placebo-Controlled Trial of Percutaneous Coronary Intervention for Stable Angina
Christopher A Rajkumar1, Michael J Foley1, Fiyyaz Ahmed-Jushuf1
1From Imperial College London (C.A.R., M.J.F., F.A.-J., F.A.S., S.G., R.K., R.P., G.D.C., J.P.H., D.P.F., M.J.S.-S., R.K.A.-L.), Imperial College Healthcare NHS Trust (C.A.R., M.J.F., F.A.-J., F.A.S., S.S.N., S.G., R.K., R.P., S.S., G.D.C., J.P.H., D.P.F., M.J.S.-S., R.K.A.-L.), Barking Havering and Redbridge University Hospitals NHS Trust (A.N.N., A.S.), Royal Free London NHS Foundation Trust (T. Kotecha), St. George's University Hospitals NHS Foundation Trust (R.W., J.C.S.), St. George's University of London (J.C.S.), Queen Mary University of London (D.J.C., A.S.), and Barts Health NHS Trust (A.S.), London, Essex Cardiothoracic Centre, Mid and South Essex NHS Foundation Trust, Basildon (J.R.D., R.G., G.C., J.N.D., T.R.K.), Anglia Ruskin University, Chelmsford (J.R.D., G.C., T.R.K.), University Hospitals Dorset NHS Foundation Trust, Poole (P.D.O., J.D.), Portsmouth Hospitals University NHS Trust, Portsmouth (P.H.), Worcestershire Acute Hospitals NHS Trust, Worcester (H.R., L.M.), University Hospital Southampton NHS Foundation Trust and the University of Southampton, Southampton (N.C.), Royal Berkshire NHS Foundation Trust, Reading (N.R.), Salisbury NHS Foundation Trust, Salisbury (M.S.), Cardiff and Vale University Health Board, Cardiff (T. Kinnaird), Keele University, Keele (T. Kinnaird), Buckinghamshire Healthcare NHS Trust, Amersham (R.P.), and West Hertfordshire Hospitals NHS Trust, Watford (J.S.) - all in the United Kingdom.
Background:
Percutaneous coronary intervention (PCI) is frequently performed to reduce the symptoms of stable angina. Whether PCI relieves angina more than a placebo procedure in patients who are not receiving antianginal medication remains unknown.
Methods:
We conducted a double-blind, randomized, placebo-controlled trial of PCI in patients with stable angina. Patients stopped all antianginal medications and underwent a 2-week symptom assessment phase before randomization. Patients were then randomly assigned in a 1:1 ratio to undergo PCI or a placebo procedure and were followed for 12 weeks. The primary end point was the angina symptom score, which was calculated daily on the basis of the number of angina episodes that occurred on a given day, the number of antianginal medications prescribed on that day, and clinical events, including the occurrence of unblinding owing to unacceptable angina or acute coronary syndrome or death. Scores range from 0 to 79, with higher scores indicating worse health status with respect to angina.
Results:
A total of 301 patients underwent randomization: 151 to the PCI group and 150 to the placebo group. The mean (±SD) age was 64±9 years, and 79% were men. Ischemia was present in one cardiac territory in 242 patients (80%), in two territories in 52 patients (17%), and in three territories in 7 patients (2%). In the target vessels, the median fractional flow reserve was 0.63 (interquartile range, 0.49 to 0.75), and the median instantaneous wave-free ratio was 0.78 (interquartile range, 0.55 to 0.87). At the 12-week follow-up, the mean angina symptom score was 2.9 in the PCI group and 5.6 in the placebo group (odds ratio, 2.21; 95% confidence interval, 1.41 to 3.47; P<0.001). One patient in the placebo group had unacceptable angina leading to unblinding. Acute coronary syndromes occurred in 4 patients in the PCI group and in 6 patients in the placebo group.
Conclusions:
Among patients with stable angina who were receiving little or no antianginal medication and had objective evidence of ischemia, PCI resulted in a lower angina symptom score than a placebo procedure, indicating a better health status with respect to angina. (Funded by the National Institute for Health and Care Research Imperial Biomedical Research Centre and others; ORBITA-2 ClinicalTrials.gov number, NCT03742050.).
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