Abstract
BackgroundA growing population of patients lives with severe coronary artery disease not amenable to coronary revascularization and with refractory angina despite optimal medical therapy. Percutaneous reduction of the coronary sinus is an emerging treatment for myocardial ischemia that increases coronary sinus pressure to promote a transcollateral redistribution of coronary artery in-flow from nonischemic to ischemic subendocardial territories. A first-in-man study has demonstrated that the percutaneous reduction of the coronary sinus can be performed safely in such patients. The COSIRA trial seeks to assess whether a percutaneous reduction of the coronary sinus can improve the symptoms of refractory angina in patients with limited revascularization options.Methods/DesignThe COSIRA trial is a phase II double-blind, sham-controlled, randomized parallel trial comparing the percutaneously implanted coronary sinus Reducer (Neovasc Inc, Richmond, BC, Canada) to a sham implantation in 124 patients enrolled in Canada, Belgium, England, Scotland, Sweden and Denmark. All patients need to have stable Canadian Cardiovascular Society (CCS) class III or IV angina despite optimal medical therapy, with evidence of reversible ischemia related to disease in the left coronary artery, and a left ventricular ejection fraction >25%. Participants experiencing an improvement in their angina ≥2 CCS classes six months after the randomization will meet the primary efficacy endpoint. The secondary objective of this trial is to test whether coronary sinus Reducer implantation will improve left ventricular ischemia, as measured by the improvement in dobutamine echocardiogram wall motion score index and in time to 1 mm ST-segment depression from baseline to six-month post-implantation.DiscussionBased on previous observations, the COSIRA is expected to provide a significant positive result or an informative null result upon which rational development decisions can be based. Patient safety is a central concern and extensive monitoring should allow an appropriate investigation of the safety related to the coronary sinus Reducer.Trial registrationClinicalTrials.gov identifier - NCT01205893.
Highlights
A growing population of patients lives with severe coronary artery disease not amenable to coronary revascularization and with refractory angina despite optimal medical therapy
Patient safety is a central concern and extensive monitoring should allow an appropriate investigation of the safety related to the coronary sinus Reducer
The COSIRA trial will investigate whether the percutaneous reduction of the coronary sinus (CS) will reduce angina in patients with refractory angina
Summary
A growing population of patients lives with severe coronary artery disease not amenable to coronary revascularization and with refractory angina despite optimal medical therapy. In patients with stable coronary artery disease (CAD), a successful treatment is defined as a complete, or nearly complete, elimination of anginal chest pain with improved functional class and a return to normal activities [1] This goal cannot be achieved in a growing population of patients [2,3] with advanced CAD having no option for further revascularization either by percutaneous coronary intervention (PCI) or by coronary artery bypass graft (CABG) surgery. These ‘no option’ patients remain severely disabled by chronic refractory angina pectoris, despite optimal medical therapy. The success of CABG decreased interest in surgical ligation of CS but the current rise in patients with refractory angina creates an opportunity to reconsider this approach
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