Coronary disease & ACSRandomised controlled trial
Coronary sinus reducer for the treatment of refractory angina (ORBITA-COSMIC): a randomised, placebo-controlled trial
- Randomised controlled trial
- double-blind
- placebo-controlled
- 6 UK hospitals
- Bayesian analysis
Authors' conclusion
ORBITA-COSMIC found no evidence that the CSR improved transmural myocardial perfusion, but the CSR did improve angina compared with placebo.
Study context
- Population
- Adults with angina, stable CAD, ischaemia and no further treatment options (refractory angina)50 in ITT analysis
- Participants
- 51 adults
- Comparison
- Coronary sinus reducer vs placebo procedure
- Coronary sinus reducer (CSR)n = 25
- Placebon = 26reference
- Primary endpoint
- Stress myocardial blood flow in segments ischaemic at enrolment (adenosine-stress perfusion CMR); primary symptom outcome: number of daily angina episodes
- Follow-up
- 6 months
Primary result
As reported in the abstract
Myocardial blood flow in ischaemic segments; daily angina episodes
CSR vs PlaceboDifference, mL/min per g (95% CrI)
myocardial blood flow; CrI; Pr(Benefit)=78.8%; no improvement
0.06(−0.09 to 0.20)
CSR vs PlaceboOdds ratio (95% CrI)
daily angina episodes reduced; CrI; Pr(Benefit)=99.4%
1.40(1.08–1.83)
Safety
- CSR embolisation; ACS; death
- 2 · events
CSR embolisation; ACS; death
- No ACS events or deaths in either group
Original publication
Coronary sinus reducer for the treatment of refractory angina (ORBITA-COSMIC): a randomised, placebo-controlled trial. Lancet. Published 8 April 2024. doi:10.1016/s0140-6736(24)00256-3
Summarised from the published abstract; every number is checked against it