Efficacy of a Device to Narrow the Coronary Sinus in Refractory Angina Article
Full Text via DOI: 10.1056/NEJMoa1402556 PMID: 25651246 Web of Science: 000349143600006
- Verheye, Stefan; Jolicoeur, E. Marc; Behan, Miles W.; Pettersson, Thomas; Sainsbury, Paul; Hill, Jonathan; Vrolix, Mathias; Agostoni, Pierfrancesco; Engstrom, Thomas; Labinaz, Marino; de Silva, Ranil; Schwartz, Marc; Meyten, Nathalie; Uren, Neal G.; Doucet, Serge; Tanguay, Jean-Francois; Lindsay, Steven; Henry, Timothy D.; White, Christopher J.; Edelman, Elazer R.; Banai, Shmuel
- 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.
- New England Journal of Medicine Journal
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