Neovasc’s Reducer Device for Refractory Angina Evaluated in Interim Data From REDUCER-I Study

September 28, 2021—Neovasc Inc. announced the publication of interim results from the multicenter, prospective, open-label REDUCER-I clinical study investigating patients with refractory angina treated with the Neovasc Reducer system. The Reducer has received CE Mark approval in the European Union and is under investigation in the United States for the treatment of refractory angina.

The international postmarket study, which includes a retrospective component, collected long-term data of patients with refractory angina treated with coronary sinus narrowing using the Reducer device. The publication outlines the overall clinical outcomes of the first 228 patients enrolled in the study, stated Neovasc.

The study was published by Professor Stefan Verheye, MD, et al in EuroIntervention. The study was led by Prof. Verheye, who is from the Cardiovascular Center at ZNA Middelheim Hospital in Antwerp, Belgium, and Maayan Konigstein, MD, from the Tel Aviv Medical Center in Tel Aviv, Israel.

According to Neovasc, the study’s primary efficacy endpoint was the percentage of patients who experience improvement in their angina symptoms defined as a reduction in Canadian Cardiovascular Society (CCS) grade as a measure of their disability at 6 months as compared to baseline. The primary safety endpoints are the rate of occurrence of device- and/or procedure-related periprocedural serious adverse events and major adverse cardiac events (MACEs), a composite of cardiac death, major stroke, and myocardial infarction up to 30 days post-implantation.

The company reported in the press release that the first 228 patients (81% men; 68.3 ± 9.6 years) demonstrated a procedural success rate of 99%, with a very high safety profile that translated to only one adjudicated possible procedural or device-related MACE. Mean CCS class improved from 2.8 ± 0.6 at baseline, to 1.8 ± 0.7 at 2 years. Improvement in ≥ 1 CCS class was observed in 82%, and in ≥ 2 CCS classes in 31% of patients at 2 years.

At baseline, 70% of the cohort were disabled at very minimal physical effort (CCS class III-IV). This portion was reduced to 15% at follow-up. Additional measured parameters of functional class and quality of life were also improved.

“The data published in the REDUCER-I study confirm the high safety profile of the therapy in patients suffering from refractory angina,” commented Prof. Verheye in Neovasc’s press release. “The results also demonstrate sustained improvement in angina severity and in quality of life up to 2 years. I am encouraged that we now have a therapy to offer patients who, in the past, had no treatment options. In properly selected patients, the Reducer offers hope for a return to a more normal life that is less hampered by the debilitating symptoms of refractory angina.”

Neovasc noted that in the same issue of EuroIntervention, Michael Foley, MBBS, and Rasha Al-Lamee, MBBS, from the National Heart and Lung Institute at Imperial College in London, United Kingdom, published an editorial on these findings. Dr. Foley and Dr, Lamee stated in the editorial, “The most important additive finding of REDUCER-I is the real-world procedural success and safety of a new device.” They further suggested that the ongoing ORBITA-COSMIC study and the upcoming COSIRA-II trial will be helpful to validate the Reducer device for an “important and often overlooked clinical group.”