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Efficacy of a Device to Narrow the Coronary Sinus in Refractory Angina

ORIGINAL ARTICLE Efficacy of a Device to Narrow the Coronary Sinus in Refractory Angina Stefan Verheye, M.D., Ph.D., E. Marc Jolicœur, M.D., Miles W. Behan, M.D., Thomas Pettersson, M.D., Paul Sainsbury, M.D., Jonathan Hill, M.D., Mathias Vrolix, M.D., Pierfrancesco Agostoni, M.D., Thomas Engstrom, M.D., Marino Labinaz, M.D., Ranil de Silva, M.D., Marc Schwartz, R.C.I.S., Nathalie Meyten, M.D., Neal G. Uren, M.D., Serge Doucet, M.D., Jean-François Tanguay, M.D., Steven Lindsay, M.D., Timothy D. Henry, M.D., Christopher J. White, M.D., Elazer R. Edelman, M.D., Ph.D., and Shmuel Banai, M.D. N Engl J Med 2015; 372:519-527February 5, 2015DOI: 10.1056/NEJMoa1402556

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.) Supported by Neovasc.

Disclosure forms provided by the authors are available with the full text of the article at NEJM.org. SOURCE INFORMATION From Antwerp Cardiovascular Center, Ziekenhuis Netwerk Antwerpen Middelheim, Antwerp (S.V., N.M.), and Ziekenhuis Oost–Limburg Hospital, Genk (M.V.) — both in Belgium; Montreal Heart Institute, Montreal (E.M.J., S.D., J.-F.T.), Ottawa Heart Institute, Ottawa (M.L.), and Neovasc, Richmond, BC (M.S.) — all in Canada; Royal Infirmary of Edinburgh, Edinburgh (M.W.B., N.G.U.), Bradford Royal Infirmary, Bradford (P.S., S.L.), and Kings College Hospital (J.H.) and the National Heart and Lung Institute, Imperial College London, and National Institute for Health Research Cardiovascular Biomedical Research Unit, Royal Brompton and Harefield NHS Foundation Trust (R.S.), London — all in the United Kingdom; Kristianstad Central Hospital, Kristianstad, Sweden (T.P.); University Medical Center Utrecht, Utrecht, the Netherlands (P.A.); Rigshospitalet, Copenhagen (T.E.); Cedars–Sinai Medical Center, Los Angeles (T.D.H.); John Ochsner Heart and Vascular Institute, University of Queensland–Ochsner Clinical School, New Orleans (C.J.W.); the Institute for Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge, and the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston — both in Massachusetts (E.R.E.); and Tel Aviv Medical Center, Tel Aviv University Medical School, Tel Aviv, Israel (S.B.). Address reprint requests to Dr. Banai at the Tel Aviv Medical Center, 6 Weizman St., Tel Aviv 64239, Israel, or at banais@netvision.net.il.Share/Bookmark

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