Neovasc has announced that the topline results from its COSIRA trial (a multicentre, prospective, randomised, sham-controlled study) indicate that the company’s percutaneous device (Reducer) significantly improves the symptoms and functioning of patients with refractory angina.
According to a press release, the COSIRA (Coronary sinus reducer for treatment of refractory angina) trial assessed the safety and efficacy of the Reducer in 104 patients in the European Union and Canada. Patients were randomised 1:1 between treatment and sham control arms. Its primary endpoint was a two-class improvement six months after implantation in patients’ ratings on the Canadian Cardiovascular Society (CCS) angina grading scale. Only patients with severe angina, CCS Class three or four were enrolled in the study.
The topline analysis showed that the study met the primary endpoint, with patients receiving the Reducer achieving a statistically significant improvement in CCS scores (two classes or better) compared to patients receiving a sham control (p-value = 0.024). 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-value = 0.003).
Tim Henry, director of Cardiology, Cedars-Sinai Heart Institute in Los Angeles, USA, noted, “Patients with refractory angina are a growing subset of patients and have limited treatment options. Although we await the final results, these preliminary results from the COSIRA study suggest that the Neovasc Reducer may provide an exciting new option for these challenging patients.”
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 ischaemic 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 complete results of the COSIRA trial are being submitted as a late-breaking clinical trial presentation at the annual meeting of the American College of Cardiology (29–31 March, Washington DC, USA)