Safety and Efficacy Results Published From Neovasc's REDUCE Study
August 6, 2018—Neovasc Inc. announced the publication of results from the REDUCE study by Francesco Giannini, MD, et al online ahead of print in International Journal of Cardiology.
The multicenter REDUCE clinical registry is evaluating the safety and effectiveness of Neovasc's Reducer device, which received CE Mark approval and has been commercially available in Europe since 2015 for the treatment of refractory angina. Reducer is not currently commercially available in the United States.
The efficacy endpoint was the improvement of quality of life and reduction of angina pectoris symptoms in a real-world cohort of 141 patients with coronary artery disease and chronic refractory angina at three high-volume medical centers in Milan, Italy; Tel Aviv, Israel; and Antwerp, Belgium. The safety endpoint of the study was to evaluate the rate of successful Reducer delivery and deployment in the absence of any device-related events.
According to the company, the findings demonstrated that treatment with the Reducer device was very safe and significantly reduced the severity of angina as measured by the Canadian Cardiovascular Society (CCS) classification, with a mean at baseline of 3.05 ± 0.53 reduced to 1.63 ± 0.98 at follow-up (P < .001).
Overall, results show that 81% of the patients experienced improvement in their angina severity by at least one CCS class, and 45% of the patients became free of any limiting angina as they improved by two or more grades in CCS class. All parameters of quality of life as measured by the Seattle Angina Questionnaire significantly improved (P < .001). These benefits translated into a significant reduction in the mean number of anti-ischemic drugs prescribed, from 2.37 ± 0.97 to 2.17 ± 0.95 (P = .003).
According to the company, the results are consistent with those of the COSIRA (Coronary Sinus Reducer for Treatment of Refractory Angina) randomized sham-controlled clinical trial. In February 2013, the final results from COSIRA were published by Stefan Verheye, MD, et al in The New England Journal of Medicine (2015;372:519–527).