Implantation of a coronary-sinus reducing device improved angina by at least two CCS classes in 35% of patients compared to 15% with a sham procedure (P=0.02).
RCT (n=104)
Does implantation of a coronary-sinus reducing device improve angina symptoms in patients with refractory angina who are not candidates for revascularization?
Implantation of a coronary-sinus reducing device significantly improves symptoms and quality of life in patients with refractory angina who are ineligible for revascularization.
Absolute Event Rate: 35% vs 15%
p-value: p=0.02
BACKGROUND: Many patients with coronary artery disease who are not candidates for revascularization have refractory angina despite standard medical therapy. The balloon-expandable, stainless steel, hourglass-shaped, coronary-sinus reducing device creates a focal narrowing and increases pressure in the coronary sinus, thus redistributing blood into ischemic myocardium. METHODS: We 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 end point 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, 1 patient in the treatment group had had a myocardial infarction; in the control group, 1 patient had died and 3 had had a myocardial infarction. CONCLUSIONS: In this small clinical trial, 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. (Funded by Neovasc; COSIRA ClinicalTrials.gov number, NCT01205893.).
Verheye et al. (Wed,) conducted a rct in Refractory angina (n=104). Coronary-sinus reducing device vs. Sham procedure was evaluated on Improvement of at least two CCS angina classes at 6 months (p=0.02). Implantation of a coronary-sinus reducing device improved angina by at least two CCS classes in 35% of patients compared to 15% with a sham procedure (P=0.02).