Published COSIRA Data Show Efficacy of Neovasc’s Reducer to Treat Refractory Angina
February 5, 2015—Neovasc Inc. announced that the final results from its COSIRA (Coronary Sinus Reducer for Treatment of Refractory Angina) study were published by Stefan Verheye, MD, et al in The New England Journal of Medicine (2015;372:519–527). The study assessed the efficacy and safety of the Neovasc Reducer for treatment of refractory angina (RA).
According to the company, the COSIRA trial met its primary endpoint, demonstrating the efficacy of the Neovasc Reducer in relieving angina symptoms.
Dr. Verheye, who served as principal investigator for COSIRA, presented the final data in March 2014 at ACC.14, the 63rd annual scientific session of the American College of Cardiology in Washington, DC. Dr. Verheye is a senior interventional cardiologist at the Antwerp Cardiovascular Center/ZNA Middelheim in Antwerp, Belgium.
The trial was a prospective, multicenter, sham-controlled, randomized, double-blinded study assessing the safety and efficacy of the Reducer in 104 patients in Europe and Canada. Patients were randomized 1:1 between treatment and sham control arms. Its primary endpoint was a two-class improvement in the Canadian Cardiovascular Society (CCS) angina grading scale at 6 months after implantation of the Reducer in patients with severe disabling RA. Only patients with severe angina, CCS class 3 or 4, were enrolled in the COSIRA trial, noted the company.
As summarized by Neovasc, the COSIRA data demonstrated that patients treated with the Reducer achieved a statistically significant improvement in CCS angina grading scale scores (two classes or better) compared to those patients in the sham control arm (P = .024). Patients treated with the Reducer were 2.3 times more likely to see an improvement of two classes or better in CCS score than the sham control arm. The analysis also demonstrated that patients treated with the Reducer showed a statistically significant improvement of one or more CCS classes compared to the sham control patients (P = .003). The study also demonstrated a 96.2% technical success rate and a 100% procedural success rate for Reducer implantation.
In the press release, Dr. Verheye commented, “It is important to emphasize that these RA patients are severely restricted in their daily living due to chronic, debilitating chest pain. Even simple activities such as standing up or walking a small distance from one room to another can be difficult to perform. Previously faced with virtually no effective treatment options, these positive results clearly illustrate that the Reducer has the potential to transform the lives of millions of patients. Add to this fact that implanting the Reducer is a straightforward procedure that can be easily adopted into medical practice. It is similar to implanting a coronary artery stent, which happens thousands of times every day.”
Shmuel Banai, MD, added, “The results from this rigorously designed trial speak for themselves. They demonstrate a clear clinical benefit and highly safe procedure. For RA patients, even a one-grade improvement in CCS class makes a dramatic impact on their quality of life, let alone a two-grade improvement, which occurred in 35% of the treated patients.” Dr. Banai is Director of Interventional Cardiology in the Cardiology Department at the Tel Aviv Medical Center in Tel Aviv, Israel.