TY - JOUR
T1 - Efficacy of a device to narrow the coronary sinus in refractory Angina
AU - Verheye, Stefan
AU - Jolicœur, E. Marc
AU - Behan, Miles W.
AU - Pettersson, Thomas
AU - Sainsbury, Paul
AU - Hill, Jonathan
AU - Vrolix, Mathias
AU - Agostoni, Pierfrancesco
AU - Engstrom, Thomas
AU - Labinaz, Marino
AU - De Silva, Ranil
AU - Schwartz, Marc
AU - Meyten, Nathalie
AU - Uren, Neal G.
AU - Doucet, Serge
AU - Tanguay, Jean François
AU - Lindsay, Steven
AU - Henry, Timothy D.
AU - White, Christopher J.
AU - Edelman, Elazer R.
AU - Banai, Shmuel
N1 - Publisher Copyright:
Copyright © 2015 Massachusetts Medical Society.
PY - 2015/2/5
Y1 - 2015/2/5
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=84925546371&partnerID=8YFLogxK
U2 - 10.1056/NEJMoa1402556
DO - 10.1056/NEJMoa1402556
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C2 - 25651246
AN - SCOPUS:84925546371
SN - 0028-4793
VL - 372
SP - 519
EP - 527
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 6
ER -
