Coronary-Sinus Reducing Device in Refractory Angina | Journal Scan

Study Questions:

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?

Methods:

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.

Results:

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.

Conclusions:

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.

Perspective:

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.

Clinical Topics: Noninvasive Imaging, Echocardiography/Ultrasound

Keywords: Angina Pectoris, Coronary Artery Disease, Coronary Disease, Myocardial Infarction, Myocardial Ischemia, Quality of Life, Dobutamine, Echocardiography, Control Groups


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