COSIRA Data Presented for Neovasc's Reducer to Treat Refractory Angina

March 31, 2014—Neovasc Inc. (Vancouver, BC, Canada) reported that final data from its COSIRA trial (Coronary Sinus Reducer for Treatment of Refractory Angina) of the Neovasc Reducer, a percutaneous device for the treatment of refractory angina, were presented at ACC.14, the 63^rd annual scientific session of the American College of Cardiology. The COSIRA trial was a prospective, multicenter, sham-controlled, randomized (1:1), double-blinded study assessing the safety and efficacy of the Reducer in 104 patients in the European Union and Canada. COSIRA Principal Investigator Stefan Verheye, MD, who is Senior Interventional Cardiologist at the Antwerp Cardiovascular Center/ZNA Middelheim in Antwerp, Belgium, presented the data.

The final study data presented at ACC.14 provide details of the primary endpoint analysis and show that patients receiving the Reducer also demonstrated potential improvement on important secondary endpoints. In November 2013, the company announced the topline data from the COSIRA trial indicated that the study had met its primary endpoint, significantly improving the symptoms and functioning of patients disabled by previously untreatable refractory angina.

In Neovasc’s press release, Dr. Verheye commented, “These detailed COSIRA data reinforces the topline results showing that the Reducer represents a potential breakthrough in refractory angina treatment. Many patients receiving the Neovasc Reducer were able to resume daily activities that can have a profound impact on their quality of life. The Reducer’s positive impact on multiple secondary endpoints was also encouraging. It is noteworthy that the implantation procedure is quick and uncomplicated, and to date the Reducer appears safe and well-tolerated in ongoing use.”

According to Neovasc, the COSIRA data presented at ACC.14 showed that patients receiving the Reducer achieved a statistically significant improvement in Canadian Cardiovascular Society (CCS) angina grading scale scores (two classes or better) compared to patients receiving a sham control (P = .024). Only patients with severe angina, CCS class 3 or 4, were enrolled in the COSIRA trial, noted the company.

Patients treated with a Reducer were 2.3 times more likely so see an improvement of two classes or better in CCS score than the sham controls. The analysis also showed 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).

On the secondary endpoints, refractory angina patients who were implanted with the Reducer demonstrated strong signals of improvements in quality of life, total exercise duration, and anginal stability and anginal frequency scores, as well as in other measures of cardiovascular fitness. However, these secondary results did not meet statistical significance. The study also demonstrated a 96.2% technical success rate and a 100% procedural success rate for Reducer implantation. 

Neovasc advised that the Reducer has European CE Mark approval for the treatment of refractory angina. The Reducer is designed to provide relief of angina symptoms by altering blood flow in the heart’s circulatory system, thereby increasing the perfusion of oxygenated blood to ischemic areas of the heart muscle. Placement of the Reducer is performed using a minimally invasive transvenous procedure that is completed in approximately 20 minutes.