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Coronary-Sinus Reducing Device Improved Symptoms, QOL in Patients with Angina
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In the phase 2 COSIRA trial, implantation of a coronary-sinus reducing device significantly improved symptoms and quality of life in patients with refractory angina ineligible for coronary revascularization.
Researchers assigned 104 patients with Canadian Cardiovascular Society (CCS) class III or IV angina and myocardial ischemia ineligible for revascularization to the balloon-expandable coronary-sinus reducing device (Reducer, Neovasc) or a sham procedure.
The diameter of the stainless steel coronary-sinus reducing device expands with the inflation of the semicompliant balloon, which has an hourglass shape and conforms to the anatomy of the coronary sinus. After implantation via a catheter, the central orifice of the device becomes the sole path for blood flow through the coronary sinus, resulting in redistribution of blood from the less ischemic epicardium to the ischemic endocardium.
The device group exhibited greater improvement in the primary endpoint of at least two CCS angina classes at 6 months (35% vs. 15%; P = .02), and at least one class at 6 months (71% vs. 42%; P = .003). In addition, the device group improved by 17.6 points on a 100-point scale using the Seattle Angina Questionnaire vs. 7.6 points for the control group (P = .03).
The device and control groups did not differ in improved exercise time (13% vs. 1%, respectively; P = .07) or mean change in wall-motion index as assessed by dobutamine echocardiography (14% vs. 8%, respectively; P = .2).
During the study period, there was one MI in the device group and one death and three MIs in the control group. – by Erik Swain
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Perspective
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Carl J. Pepine, MD
This is an important issue. Our population with treatment-refractory angina is growing, and these refractory patients have poor quality of life with repeated hospitalizations and high health resource utilization, reemphasizing the need for novel therapeutics. This work, based on the surgical procedure pioneered by Beck, is very exciting. Although specific mechanisms responsible for benefit are unknown, these results suggest that the coronary microcirculation contributes to symptoms and signs of ischemia in refractory patients. Improved microvessel function, to provide redistribution of blood from less ischemic to more ischemic myocardium, could operate. If so, the coronary microcirculation may be a suitable therapeutic target for treatment of ischemia. This suggestion is supported by very encouraging results with cell-based therapy centered on CD34+ cells in several early trials (Losordo DW, et al. Circ Res. 2011;109:428-435).
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