Key result
Coronary Sinus Reducer implantation linked to ~1.4-point reduction in CCS angina score at 6 months.
Why the study?
Although preclinical experiments showed that the Coronary Sinus Reducer was safe and improved ischemic parameters by elevating coronary sinus pressure, its safety and feasibility in patients with refractory angina who are not candidates for conventional revascularization needed evaluation.
Is percutaneous implantation of the Coronary Sinus Reducer safe and feasible for improving angina and myocardial ischemia in patients with chronic refractory angina who are not candidates for conventional revascularization?
Is percutaneous implantation of the Coronary Sinus Reducer safe and feasible for improving angina and myocardial ischemia in patients with chronic refractory angina who are not candidates for conventional revascularization?
This first-in-human feasibility study demonstrates that percutaneous implantation of the Coronary Sinus Reducer is safe and associated with significant improvements in angina symptoms and objective measures of myocardial ischemia in patients with refractory angina.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“The results from the Reducer three-year follow-up study confirm the positive data seen in the initial trial and are very promising. We are encouraged by the continuing excellent safety profile of the Reducer and its apparent ability to maintain improvement in angina symptoms over time. This data suggests that the Reducer may offer a viable long-term treatment option for patients with refractory angina who lack other alternatives for relieving their symptoms and improving their quality of life.”
“Thus, the prior data provided a mixed picture regarding objective benefit of CSR implantation.”
“This new data demonstrates the ultimate success of the Reducer for the treatment of refractory angina, with proof of sustained efficacy and complete safety for these patients 12 years after implantation.”
May support evaluation of Coronary Sinus Reducer in refractory angina; leaves open efficacy confirmation in randomized trials.
Objectives This study sought to evaluate the safety of the Coronary Sinus Reducer (Neovasc Medical, Inc., Or Yehuda, Israel) as a potential alternate therapy for patients with refractory angina who are not candidates for conventional revascularization procedures. Background Increased coronary sinus (CS) pressure can reduce myocardial ischemia by redistribution of blood from nonischemic to ischemic territories. The Coronary Sinus Reducer is a percutaneous implantable device designed to establish CS narrowing and to elevate CS pressure. In preclinical experiments, implantation of the Reducer was safe and was associated with improved ischemic parameters. In the present study, the safety and feasibility of the Coronary Sinus Reducer was evaluated in patients with refractory angina who were not candidates for revascularization. Methods Fifteen coronary artery disease patients with severe angina and reversible ischemia were electively treated with the Reducer. Clinical evaluation, dobutamine echocardiography, thallium single-photon emission computed tomography, and administration of an angina questionnaire were performed before and 6 months after implantation. Cardiac computed tomography was performed 2 days and 6 months after implantation. Results All procedures were completed successfully. No procedure-related adverse events occurred during the periprocedural and the follow-up periods. Angina score improved in 12 of 14 patients. Average Canadian Cardiovascular Society score was 3.07 at baseline and 1.64 at follow-up (n = 14, p < 0.0001). Stress-induced ST-segment depression was reduced in 6 of 9 patients and was eliminated in 2 of these 6 (p = 0.047). The extent and severity of myocardial ischemia by dobutamine echocardiography and by thallium single-photon emission computed tomography was reduced (p = 0.004 [n = 13] and p = 0.042 [n = 10], respectively). Conclusions Implantation of the Coronary Sinus Reducer is feasible and safe. These findings, along with the clinical improvement observed, support further evaluation of the Reducer as an alternative treatment for patients with chronic refractory angina who are not candidates for coronary revascularization.
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Banai et al. (2007) studied Chronic refractory angina pectoris (n=15). Coronary Sinus Reducer stent vs. Baseline (pre-implantation) was evaluated on Safety (procedure-related adverse events) and Canadian Cardiovascular Society (CCS) angina score (p=<0.0001). Coronary Sinus Reducer implantation caused no procedure-related adverse events and reduced average CCS angina score from 3.07 to 1.64 at 6 months (p<0.0001).
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