Coronary sinus reducer improves symptoms, quality of life for patients with severe CAD
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Key takeaways:
- A coronary sinus reducer reduced the frequency of angina events for patients with significant CAD.
- However, the reducer did not have impact on a significant myocardial perfusion.
ATLANTA — Use of a coronary sinus reducer improved chest pain symptoms and quality of life for patients with significant coronary artery disease, despite not improving myocardial blood flow, a speaker reported.
The results of the randomized, placebo-controlled ORBITA-COSMIC trial were presented at the American College of Cardiology Scientific Session and simultaneously published in The Lancet.
“The coronary sinus reducer is the only device that is postulated to improve angina from the venous circulation,” Rasha Al-Lamee, MBBS, PhD, a clinical academic interventional cardiology consultant at Imperial College Healthcare NHS Trust and clinical reader at Imperial College London, said during a press conference. “We asked the question, what is the true placebo-controlled impact of the coronary sinus reducer on myocardial ischemia and angina.”
A coronary sinus reducer is an hourglass-shaped mesh that is percutaneously implanted in the coronary sinus to reduce angina for patients with significant CAD who do not benefit from medical therapy or revascularization, the researchers wrote in the simultaneous publication.
For this trial, Al-Lamee and colleagues enrolled 51 patients with significant CAD (86% men). After daily angina assessment for 2 weeks via smartphone app, participants were randomly assigned to the coronary sinus reducer or a sham procedure in the catheterization laboratory. All participants had internal jugular access, right atrial pressure measurement, coronary sinus venogram, auditory isolation and deep conscious sedation. The patients and caregivers remained masked through 6 months follow-up, during which time they continued to document any angina symptoms in the smartphone app.
The primary imaging outcome was change in myocardial perfusion at 6 months. The primary symptom outcome was change in reported angina events at 6 months.
On perfusion MRI, the researchers observed no significant difference in myocardial blood flow in the coronary sinus reducer arm compared with placebo (mean difference, 0.06 mL/min/g; 95% CI, 0.09 to 0.2), but some improvement was observed in subendocardial perfusion in the reducer group (mean difference, 0.09 mL/min/g; 95% credible interval, 0-0.17; probability of benefit, 78.8%).
Participants assigned to the coronary sinus reducer were more likely to have a lower number of angina events recorded during follow-up compared with the placebo arm (OR = 1.4; 95% credible interval, 1.08-1.83; probability of benefit, 99.4%).
The Seattle Angina Questionnaire angina frequency score improved to a greater degree at 6 months in the reducer group compared with the control group (probability of benefit, 99.7%), according to the researchers.
Moreover, participants in the reducer group reported higher 6-month QOL scores on the EuroQoL visual analog scale (probability of benefit, 93.3%) and MacNew Heart Disease health-related QOL questionnaire (probability of benefit, 99.4%) from baseline and compared with the placebo group.
“The ORBITA-COSMIC trial has shown that the coronary sinus reducer resulted in no improvement in transmural myocardial perfusion,” Al-Lamee said during the press conference. “However, we did see an improvement in one of the secondary image endpoints, with improvement in subendocardial perfusion. The reducer resulted in reduced angina frequency and improved heart disease-related quality of life.”
Reference:
- Coronary sinus reducer relieves angina, but how it works remains unclear. https://www.acc.org/About-ACC/Press-Releases/2024/04/08/14/27/coronary-sinus-reducer-relieves-angina-but-how-it-works-remains-unclear. Published April 8, 2024. Accessed April 12, 2024.
- Foley MJ, et al. Lancet. 2024;doi:10.1016/S0140-6736(24)00256-3.
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Al-Lamee RK, et al. Late-breaking clinical trials V. Presented at: American College of Cardiology Scientific Session; April 6-8, 2024; Atlanta.
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