Efficacy of a device to narrow the coronary sinus in refractory Angina

Stefan Verheye, E. Marc Jolicœur, Miles W. Behan, Thomas Pettersson, Paul Sainsbury, Jonathan Hill, Mathias Vrolix, Pierfrancesco Agostoni, Thomas Engstrom, Marino Labinaz, Ranil De Silva, Marc Schwartz, Nathalie Meyten, Neal G. Uren, Serge Doucet, Jean François Tanguay, Steven Lindsay, Timothy D. Henry, Christopher J. White, Elazer R. EdelmanShmuel Banai

Research output: Contribution to journalArticlepeer-review

Abstract

BACKGROUND: Many patients with coronary artery disease who are not candidates for revascularization have refractory angina despite standard medical therapy. The balloonexpandable, 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.

Original languageEnglish (US)
Pages (from-to)519-527
Number of pages9
JournalNew England Journal of Medicine
Volume372
Issue number6
DOIs
StatePublished - Feb 5 2015

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