The final results from COSIRA study assessing the efficacy and safety of the Neovasc Reducer for treatment of refractory angina, are published in the New England Journal of Medicine ( NEJM ).
Refractory angina is a debilitating disease involving chronic chest pain and affecting millions of patients worldwide who have limited treatment options.
Refractory angina 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.
The COSIRA study met its primary endpoint, demonstrating the efficacy of Reducer in relieving angina symptoms in these patients.
For refractory angina patients, even a 1-grade improvement in CCS class has a dramatic impact on quality of life. The Canadian Cardiovascular Society ( CCS ) angina grading scale is 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 COSIRA data have demonstrated that patients treated with Reducer achieved a statistically significant improvement in CCS angina grading scale scores ( 2 classes or better ) compared to those patients in the sham control arm, ( p-value = 0.024 ).
Patients treated with Reducer were 2.3 times more likely to see an improvement of 2 classes or better in CCS score than the sham control arm.
The analysis has also demonstrated that patients treated with Reducer has shown a statistically significant improvement of one or more CCS classes compared to the sham control patients ( p-value = 0.003 ).
The study has also demonstrated a 96.2% technical success rate and a 100% procedural success rate for Reducer implantation.
The COSIRA ( COronary SInus Reducer for Treatment of Refractory Angina ) trial was a prospective, multicenter, sham-controlled, randomized, double-blinded study assessing the safety and efficacy of Reducer in 104 patients in Europe and Canada.
Patients were randomized 1:1 between treatment and sham control arms.
The primary endpoint was a 2-class improvement six months after implantation of Reducer in patients with severe disabling refractory angina. ( Xagena )
Source: Neovasc, 2015