Related Experiment Video
Updated: May 14, 2026
Testing Acetylcholine Followed by Adenosine for Invasive Diagnosis of Coronary Vasomotor Disorders
Published on: February 3, 2021
A phase II, sham-controlled, double-blinded study testing the safety and efficacy of the coronary sinus reducer in
E Marc Jolicœur1, Shmuel Banai, Timothy D Henry
1Montreal Heart Institute, Université de Montréal, 5000 Bélanger Street East, Montréal, Québec Q H1T 1C8, Canada. marc.jolicoeur@icm-mhi.org
Insights
The COSIRA trial investigated the coronary sinus Reducer for refractory angina in severe coronary artery disease patients. Results will inform future development of this novel treatment for myocardial ischemia.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Severe coronary artery disease (CAD) often leads to refractory angina unresponsive to optimal medical therapy.
- Percutaneous coronary sinus reduction is an emerging therapy for myocardial ischemia.
- This procedure aims to redistribute coronary blood flow from non-ischemic to ischemic areas.
Purpose of the Study:
- To evaluate the safety and efficacy of the coronary sinus Reducer in patients with refractory angina and limited revascularization options.
- To assess symptom improvement in angina severity.
- To measure improvements in left ventricular ischemia.
Main Methods:
- Phase II, double-blind, sham-controlled, randomized trial (COSIRA).
- 124 patients with Canadian Cardiovascular Society (CCS) class III or IV angina enrolled across multiple countries.
- Comparison between percutaneously implanted coronary sinus Reducer and sham procedure.
Main Results:
- Primary efficacy endpoint: improvement of angina by ≥2 CCS classes at six months.
- Secondary endpoints: improvement in left ventricular ischemia via dobutamine echocardiogram and time to ST-segment depression.
- Patient safety monitored throughout the trial.
Conclusions:
- The COSIRA trial is expected to yield significant positive or informative null results.
- Findings will guide further development of the coronary sinus Reducer.
- Patient safety is a primary concern, with extensive monitoring planned.
Background:
A 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/Design:
The 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.
Discussion:
Based 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 Registration:
ClinicalTrials.gov identifier - NCT01205893.
More Related Videos
Related Concept Videos
01:27Angina II: Classification
01:26Angina IV: Management
01:30Acute Coronary Syndrome III: Diagnostic Studies
01:25Antianginal Drugs: Calcium Channel Blockers and Ranolazine
CCBs, a diverse class that includes dihydropyridines (nifedipine) and diphenylalkylamines (verapamil and diltiazem), exert their effect by blocking calcium channels in cardiac and smooth muscle cells. This...
01:21Cardiac Catheterization II: Right Heart Catheterization
01:20Angina V: Nursing Management