Original title: Efficacy of a Device to Narrow the Coronary Sinus in Refractory Angina. Reference: Verheye S et al. N Engl J Med 2015 Feb 5;372(6):519-27.
The number of patients with severe diffuse coronary artery disease who are not candidates for revascularization is growing in Western countries, generating multiple procedures and increasing healthcare expenditure. New and unconventional solutions are required to solve this problem.
This phase 2 study, multicenter and randomized, included 104 functional class III or IV patients who were not candidates for revascularization. Patients were randomized 1:1 to coronary-sinus Reducer device implantation (balloon-expandable, stainless steel device, aiming at reducing venous return and increasing retrograde pressure of coronary perfusion) vs. sham procedure (control group).
Primary end point was improvement of two or more angina classes from baseline to 6 months and secondary end point, one or more angina class from baseline to 6 months, and exercise tolerance assessed by symptom limited stress test.
40% of the population was diabetic and more than half presented prior infarction and prior myocardial revascularization surgery. Implantation success was 96% (50 patients).
At 6 months follow up, primary end point was in favor of the treated group (35% vs 15%; p=0.02) as well as secondary end point (71% vs 42%; p=0.003). There was also significant improvement of quality of life (17.6 points vs. 7.6 points; p=0.048), better tolerance of physical exercise and improvement in regional motion of the left ventricle in the echocardiography. A control CT was performed 6 months after procedure in 26 patients and no device migration was observed.
Conclusion
In this small series, coronary sinus device implantation was associated with a significant improvement of symptoms and quality of life in patients with refractory angina who are not candidates for revascularization.
Editorial Comment
In 1950, Beck and Leighninger had already performed partial occlusion surgery of the coronary sinus, reducing angina and improving functional class and mortality; this has not been developed but, at present, this population is growing and requires new treatment strategies.
Most likely, with a good medical treatment, new drugs, new revascularization techniques and partial occlusion of the venous sinus, better outcomes will be obtained. However, further and more extensive research is required to get more conclusive results.
Courtesy of Dr. Carlos Fava
Interventional Cardiologist
Favaloro Foundation– Argentina
Carlos Fava