The manuscript “Safety and efficacy of the Reducer: A multicentre clinical registry—REDUCE study” has been published in the International Journal of Cardiology. In this study, the safety and effectiveness of the Reducer (Neovasc)—a CE-marked medical device designed for the treatment of refractory angina—was evaluated using a real-world cohort of 141 patients in three high-volume medical centres in Milan (Italy), Tel Aviv (Israel) and Antwerp (Belgium).
The researchers aimed to evaluate the efficacy of the Reducer in improving quality of life and reducing symptoms of angina pectoris in 141 consecutive patients suffering from coronary artery disease and chronic refractory angina. 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.
The investigator demonstrated that treatment with the Reducer was very safe and significantly reduced the severity of angina as measured by the Canadian Cardiovascular Society classification (CCS)—from a mean at baseline of 3.05±0.53 to 1.63±0.98 at follow-up (p<0.001). 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 2 or more grades in their CCS class. All parameters of quality of life as measured by the Seattle Angina Questionnaire improved significantly (p <0.001). These benefits translated into a significant reduction in the mean number of anti-ischemic drugs prescribed (2.37± 0.97 vs 2.17±0.95; p= 0.003).
Fred Colen, Neovasc’s president and chief executive officer, comments: “The publication is another ‘real-world’ non-randomised study that demonstrates clinical results in an additional 141 enrolled patients, that are remarkably consistent with the results of the COSIRA randomszed sham-controlled clinical trial. This recent manuscript published in the International Journal of Cardiology is a testament to the benefits of the Reducer as a safe device, which can provide substantial qualify of life improvements in patients with refractory angina, who do not have other suitable treatment alternatives. We are very pleased to have this data published in such a highly-regarded journal.”