ORBITA-COSMIC

Validating the Efficacy of Coronary Sinus Reducers

The ORBITA-COSMIC trial’s results have confirmed the symptomatic benefits of coronary sinus reducer therapy in treating angina. This second sham-controlled trial validates the effectiveness of reducer therapy and positions it for earlier treatment in the presence of riskier alternatives.
The Trial in Detail
The ORBITA-COSMIC trial, conducted across six UK hospitals, is a double-blind, placebo-controlled study. It enrolled patients with stable coronary artery disease and refractory angina and measured the efficacy of reducer therapy against a placebo in terms of symptom improvement and myocardial blood flow.
Key Findings
The trial observed a statistically significant reduction in the frequency of angina episodes among patients treated with reducer therapy compared to the placebo group. Furthermore, there was a marked improvement in blood flow to the subendocardium—a finding in a sham-controlled randomized trial that confirms the earlier findings of Ido (ref) in animals and Palmisano (ref) on MRI. There was no improvement in transmural myocardial perfusion.
“We are thrilled that a second sham controlled randomized trial demonstrates the benefit of coronary sinus reducer therapy. Very few interventional cardiology therapies have that level of evidence. This is significant for patients that suffer unnecessarily from angina. We are looking forward to demonstrating the value of the therapy in patients suffering from microvascular dysfunction..”

Dr. Michael Foley at the American College of Cardiology Annual Scientific Session (ACC.24), Atlanta, GA, April 8, 2024.

The Impact of Coronary Sinus Reducers on Patient Care

ORBITA-COSMIC produced placebo-controlled data showing improved patient-reported angina in a population with stable coronary artery disease, ischemia, and no further options for antianginal therapy. The results of this trial provide evidence supporting the use of reducer therapy as an additional treatment option for patients with stable coronary artery disease.

What This Means for Cardiac Health
Chronic stable angina is the most frequent and often the first manifestation of stable CAD. In most developed countries, as many as 5% of adults over 40 are affected. Despite several effective pharmacological treatments and the success of interventional cardiology, chronic stable angina remains a cause of significant disability and impaired QoL for many patients*.

The data from ORBITA-COSMIC provide evidence for the use of Coronary Sinus Reduction therapy as an antianginal therapeutic option for patients with refractory angina, stable coronary artery disease, and myocardial ischemia.

Cited Sources

Foley, M. J., Rajkumar, C. A., Ahmed-Jushuf, F., et al. (2024). Coronary sinus reducer for the treatment of refractory angina (ORBITA-COSMIC): a randomised, placebo-controlled trial. The Lancet. https://doi.org/10.1016/S0140-6736(24)00256-3

Akira Ido, Coronary sinus occlusion enhances coronary collateral flow and reduces subendocardial ischemia Am J Physiol Heart Circ Physiol 280: H1361–H1367, 2001.

Anna Palmisano Feature tracking and mapping analysis of myocardial response to improved perfusion reserve in patients with refractory angina treated by coronary sinus Reducer implantation: a CMR study https://doi.org/10.1007/s10554-020-01964-9

*Unresolved issues in the management of chronic stable angina

A. John Camm a,⁎, Athanasios Manolis b, Giuseppe Ambrosio c, Caroline Daly d, Michel Komajda e, Esteban Lopez de Sa f, Jose Luis Lopez-Sendon f, Alessandro Mugelli g, Franco Muggli h, Juan Tamargo http://dx.doi.org/10.1016/j.ijcard.2015.08.045

The A-FLUX Reducer System is an investigational medical device that is not available for commercial distribution.

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References

1. Refractory Angina research report. Delve Insight Business Research, July 2021.

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