| Title: |
Coronary sinus reducer for the treatment of refractory angina (ORBITA-COSMIC): a randomised, placebo-controlled trial. |
| Authors: |
Foley, MJ; Rajkumar, CA; Ahmed-Jushuf, F; Simader, FA; Chotai, S; Pathimagaraj, RH; Mohsin, M; Salih, A; Wang, D; Dixit, P; Davies, JR; Keeble, TR; Cosgrove, C; Spratt, JC; O'Kane, PD; De Silva, R; Hill, JM; Nijjer, SS; Sen, S; Petraco, R; Mikhail, GW; Khamis, R; Kotecha, T; Harrell, FE; Kellman, P; Francis, DP; Howard, JP; Cole, GD; Shun-Shin, MJ; Al-Lamee, RK |
| Publisher Information: |
Elsevier |
| Publication Year: |
2024 |
| Collection: |
St George's University of London: Repository |
| Description: |
BACKGROUND: The coronary sinus reducer (CSR) is proposed to reduce angina in patients with stable coronary artery disease by improving myocardial perfusion. We aimed to measure its efficacy, compared with placebo, on myocardial ischaemia reduction and symptom improvement. METHODS: ORBITA-COSMIC was a double-blind, randomised, placebo-controlled trial conducted at six UK hospitals. Patients aged 18 years or older with angina, stable coronary artery disease, ischaemia, and no further options for treatment were eligible. All patients completed a quantitative adenosine-stress perfusion cardiac magnetic resonance scan, symptom and quality-of-life questionnaires, and a treadmill exercise test before entering a 2-week symptom assessment phase, in which patients reported their angina symptoms using a smartphone application (ORBITA-app). Patients were randomly assigned (1:1) to receive either CSR or placebo. Both participants and investigators were masked to study assignment. After the CSR implantation or placebo procedure, patients entered a 6-month blinded follow-up phase in which they reported their daily symptoms in the ORBITA-app. At 6 months, all assessments were repeated. The primary outcome was myocardial blood flow in segments designated ischaemic at enrolment during the adenosine-stress perfusion cardiac magnetic resonance scan. The primary symptom outcome was the number of daily angina episodes. Analysis was done by intention-to-treat and followed Bayesian methodology. The study is registered with ClinicalTrials.gov, NCT04892537, and completed. FINDINGS: Between May 26, 2021, and June 28, 2023, 61 patients were enrolled, of whom 51 (44 [86%] male; seven [14%] female) were randomly assigned to either the CSR group (n=25) or the placebo group (n=26). Of these, 50 patients were included in the intention-to-treat analysis (24 in the CSR group and 26 in the placebo group). 454 (57%) of 800 imaged cardiac segments were ischaemic at enrolment, with a median stress myocardial blood flow of 1·08 mL/min per g (IQR ... |
| Document Type: |
article in journal/newspaper |
| File Description: |
application/pdf |
| Language: |
English |
| ISSN: |
1474-547X |
| Relation: |
https://openaccess.sgul.ac.uk/id/eprint/116527/1/1-s2.0-S0140673624002563-main.pdf; https://openaccess.sgul.ac.uk/id/eprint/116527/6/1-s2.0-S0140673624002563-mmc1.pdf; Foley, MJ; Rajkumar, CA; Ahmed-Jushuf, F; Simader, FA; Chotai, S; Pathimagaraj, RH; Mohsin, M; Salih, A; Wang, D; Dixit, P; et al. Foley, MJ; Rajkumar, CA; Ahmed-Jushuf, F; Simader, FA; Chotai, S; Pathimagaraj, RH; Mohsin, M; Salih, A; Wang, D; Dixit, P; Davies, JR; Keeble, TR; Cosgrove, C; Spratt, JC; O'Kane, PD; De Silva, R; Hill, JM; Nijjer, SS; Sen, S; Petraco, R; Mikhail, GW; Khamis, R; Kotecha, T; Harrell, FE; Kellman, P; Francis, DP; Howard, JP; Cole, GD; Shun-Shin, MJ; Al-Lamee, RK (2024) Coronary sinus reducer for the treatment of refractory angina (ORBITA-COSMIC): a randomised, placebo-controlled trial. Lancet, 403 (10436). pp. 1543-1553. ISSN 1474-547X https://doi.org/10.1016/S0140-6736(24)00256-3 SGUL Authors: Spratt, James |
| DOI: |
10.1016/S0140-6736(24)00256-3 |
| Availability: |
https://openaccess.sgul.ac.uk/id/eprint/116527/; https://doi.org/10.1016/S0140-6736(24)00256-3 |
| Rights: |
cc_by_4 |
| Accession Number: |
edsbas.52D64375 |
| Database: |
BASE |