Coronary-Sinus Reducing Device in Refractory Angina | Journal Scan
What is the efficacy of the coronary-sinus reducing device in improving angina symptoms in patients with obstructive coronary artery disease with reversible myocardial ischemia, and who were not candidates for revascularization?
The investigators randomly assigned 104 patients with Canadian Cardiovascular Society (CCS) class III or IV angina (on a scale from I to IV, with higher classes indicating greater limitations on physical activity owing to angina) and myocardial ischemia, who were not candidates for revascularization, to implantation of the device (treatment group) or to a sham procedure (control group). The primary endpoint was the proportion of patients with an improvement of at least two CCS angina classes at 6 months.
A total of 35% of the patients in the treatment group (18 of 52 patients), as compared with 15% of those in the control group (8 of 52), had an improvement of at least two CCS angina classes at 6 months (p = 0.02). The device was also associated with improvement of at least one CCS angina class in 71% of the patients in the treatment group (37 of 52 patients), as compared with 42% of those in the control group (22 of 52) (p = 0.003). Quality of life as assessed with the use of the Seattle Angina Questionnaire was significantly improved in the treatment group, as compared with the control group (improvement on a 100-point scale, 17.6 vs. 7.6 points; p = 0.03). There were no significant between-group differences in improvement in exercise time or in the mean change in the wall-motion index as assessed by means of dobutamine echocardiography. At 6 months, one patient in the treatment group had a myocardial infarction; in the control group, one patient died and three had a myocardial infarction.
The authors concluded that implantation of the coronary-sinus reducing device was associated with significant improvement in symptoms and quality of life in patients with refractory angina who were not candidates for revascularization.
This small study reports that implantation of a coronary-sinus reducing device was significantly better than a sham intervention in improving angina symptoms in patients with advanced coronary artery disease who were not candidates for revascularization and whose disease was refractory to standard medical therapy. A larger trial using modalities with better fidelity to detect improvement in myocardial ischemia, such as magnetic resonance imaging and positron-emission tomography would be useful to provide more definitive evidence of efficacy of the coronary-sinus reducing device.
Keywords: Angina Pectoris, Coronary Artery Disease, Coronary Disease, Myocardial Infarction, Myocardial Ischemia, Quality of Life, Dobutamine, Echocardiography, Control Groups
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