OPKO Health, Inc. (NYSE:OPK), a multi-national biopharmaceutical and diagnostics company, today reported that Neovasc Inc. (NVC.V), a Vancouver-based company in which OPKO has made a strategic investment, reported topline results for its COSIRA trial assessing the efficacy and safety of the Neovasc ReducerTM, a novel percutaneous device for the treatment of refractory angina. The data shows that the Reducer achieved its primary endpoint, significantly improving the symptoms and functioning of patients disabled by previously untreatable refractory angina. The COSIRA trial also confirmed that the Reducer is safe and well-tolerated, with no reports of device-related serious adverse events. The safety and efficacy data from the randomized, controlled COSIRA trial is consistent with results seen in previous non-randomized pilot studies of the Reducer.
The Reducer is CE-marked in the European Union for the treatment of refractory angina, a painful and debilitating condition that occurs when the coronary arteries deliver an inadequate supply of blood to the heart muscle, despite treatment with standard revascularization or cardiac drug therapies. It affects millions of patients worldwide, who typically lead severely restricted lives as a result of their disabling symptoms, and its incidence is growing. The Reducer provides relief of angina symptoms by altering blood flow in the heart's venous 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 similar to implanting a coronary stent and takes approximately 20 minutes.
The COSIRA (Coronary Sinus Reducer for treatment of Refractory Angina) trial is a prospective, multicenter, sham-controlled, randomized, double-blinded study assessing the safety and efficacy of the Reducer in 104 patients in the European Union and Canada. Patients were randomized 1:1 between treatment and sham control arms. Its primary endpoint is a two-class improvement six months after implantation in patients' ratings on the Canadian Cardiovascular Society (CCS) angina grading scale, a four-class functional classification that is widely used to characterize the severity of angina symptoms and disability. Only patients with severe angina, CCS Class 3 or 4, were enrolled in the COSIRA trial.
The complete results of the COSIRA trial are being submitted as a Late Breaking Clinical Trial presentation at ACC.14, the 63rd Annual Scientific Session & Expo of the American College of Cardiology that will take place in Washington, DC, March 29-31, 2014.