Anesthesiology August 2024, Vol. 141, A13–A15.
Coronary sinus reducer for the treatment of refractory angina (ORBITA-COSMIC): A randomised, placebo-controlled trial. Lancet 2024; 403:1543–53. PMID: 38604209.
Limited information is available from only canine or single-arm human observational studies for coronary sinus reduction devices, a mesh percutaneously placed in primary venous drainage of the heart as antianginal therapy. This approach is postulated to redistribute perfusion from more to less well-perfused areas of the myocardium. This double-blind, randomized, placebo-controlled trial in patients with stable coronary artery disease and angina refractory to additional antianginal medication or revascularization options assessed its effect over a 6-month period after implantation. The primary outcome was myocardial blood flow at 6 months in ischemic areas compared to a baseline adenosine-stress perfusion cardiac magnetic resonance scan. The primary symptom outcome was the number of angina episodes reported in a smartphone application (ORBITA-app). Fifty-one patients (86% male; median age, 67 yr [interquartile range, 61 to 74 yr] from six United Kingdom hospitals) were randomly assigned to either coronary sinus reducer implantation (n = 25 with 1 patient not analyzed due to a serious adverse event) or a placebo procedure (n = 26). Although there was no difference in the primary outcome (difference coronary sinus reducer vs. placebo: 0.06 ml · min–1 · g–1 [95% credible interval, 0.09 to 0.20]; Pr(Benefit) = 78.8%), daily angina episodes decreased significantly (odds ratio, 1.40 [95% credible interval, 1.08 to 1.83]; Pr(Benefit) = 99.4%).
Take home message: This placebo-controlled trial of a coronary sinus reduction device failed to demonstrate an improvement in myocardial perfusion in ischemic regions in patients with refractory angina at 6 months despite a significant reduction in anginal symptoms in the treated group.