Efficacy of a device to narrow the coronary sinus in XXXX .

@entity1 @entity452 @entity583 @entity951 @entity741 @entity453 @entity65
BACKGROUND: Many @entity1 with @entity453 who are not candidates for revascularization have @entity951 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 @entity1 with @entity65 ( @entity65 ) class III or IV @entity951 (on a scale from I to IV, with higher classes indicating greater limitations on physical activity owing to @entity951 ) and @entity741 , 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 @entity1 with an improvement of at least two @entity65 @entity951 classes at 6 months. RESULTS: A total of 35% of the @entity1 in the treatment group (18 of 52 @entity1 ), as compared with 15% of those in the control group (8 of 52), had an improvement of at least two @entity65 @entity951 classes at 6 months (P=0.02). The device was also associated with improvement of at least one @entity65 @entity951 class in 71% of the @entity1 in the treatment group (37 of 52 @entity1 ), 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 @entity452 echocardiography. At 6 months, 1 @entity1 in the treatment group had had a @entity583 ; in the control group, 1 @entity1 had died and 3 had had a @entity583 . 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 @entity1 with @entity951 who were not candidates for revascularization. (Funded by Neovasc; COSIRA ClinicalTrials.gov number, NCT01205893.).
