Neovasc reported that final data from its COSIRA trial assessing the efficacy and safety of the Neovasc Reducer, a novel percutaneous device for the treatment of refractory angina, were presented on March 29, 2014 in a Featured Clinical Research Presentation at ACC.14, the American College of Cardiology 63rd Annual Scientific Session & Expo.
In November 2013, Neovasc announced topline data indicating that the COSIRA trial had met its primary endpoint, significantly improving the symptoms and functioning of patients disabled by previously untreatable refractory angina. The final study data presented at ACC.14 provides details of primary endpoint analysis and shows that patients receiving the Reducer also demonstrated potential improvement on important secondary endpoints.
The Reducer is CE-marked in the European Union for the treatment of refractory angina. The Reducer provides relief of angina symptoms by altering blood flow in the heart’s circulatory 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 is completed in approximately 20 minutes.
Stefan Verheye, senior interventional cardiologist at the Antwerp Cardiovascular Center / ZNA Middelheim and principal investigator of the COSIRA trial, presented the COSIRA data at ACC.14. Verheye commented, “This detailed COSIRA data reinforces the top line 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.”
The presented COSIRA data 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-value = 0.024). 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-value = 0.003). On the secondary endpoints, refractory angina patients 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.