| Title: |
A Placebo-Controlled Trial of Percutaneous Coronary Intervention for Stable Angina. |
| Authors: |
Rajkumar, CA; Foley, MJ; Ahmed-Jushuf, F; Nowbar, AN; Simader, FA; Davies, JR; O'Kane, PD; Haworth, P; Routledge, H; Kotecha, T; Gamma, R; Clesham, G; Williams, R; Din, J; Nijjer, SS; Curzen, N; Ruparelia, N; Sinha, M; Dungu, JN; Ganesananthan, S; Khamis, R; Mughal, L; Kinnaird, T; Petraco, R; Spratt, JC; Sen, S; Sehmi, J; Collier, DJ; Sohaib, A; Keeble, TR; Cole, GD; Howard, JP; Francis, DP; Shun-Shin, MJ; Al-Lamee, RK; ORBITA-2 Investigators |
| Publication Year: |
2023 |
| Collection: |
Queen Mary University of London: Queen Mary Research Online (QMRO) |
| Subject Terms: |
Aged; Female; Humans; Male; Middle Aged; Acute Coronary Syndrome; Angina; Stable; Cardiovascular Agents; Fractional Flow Reserve; Myocardial; Health Status; Percutaneous Coronary Intervention; Treatment Outcome; Double-Blind Method; Myocardial Ischemia |
| Description: |
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 |
| Document Type: |
article in journal/newspaper |
| File Description: |
2319 - 2330 |
| Language: |
English |
| Relation: |
N Engl J Med; https://qmro.qmul.ac.uk/xmlui/handle/123456789/95324 |
| DOI: |
10.1056/NEJMoa2310610 |
| Availability: |
https://qmro.qmul.ac.uk/xmlui/handle/123456789/95324; https://doi.org/10.1056/NEJMoa2310610 |
| Rights: |
© 2023, Massachusetts Medical Society |
| Accession Number: |
edsbas.B808032E |
| Database: |
BASE |