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

Verheye, Stefan, Jolicœur, 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-François, Lindsay, Steven, Henry, Timothy D., White, Christopher J., Edelman, Elazer R. and Banai, Shmuel (2015) Efficacy of a device to narrow the coronary sinus in refractory Angina. New England Journal of Medicine, 372 6: 519-527. doi:10.1056/NEJMoa1402556


Author Verheye, Stefan
Jolicœur, 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-François
Lindsay, Steven
Henry, Timothy D.
White, Christopher J.
Edelman, Elazer R.
Banai, Shmuel
Title Efficacy of a device to narrow the coronary sinus in refractory Angina
Journal name New England Journal of Medicine   Check publisher's open access policy
ISSN 1533-4406
0028-4793
Publication date 2015-02-05
Sub-type Article (original research)
DOI 10.1056/NEJMoa1402556
Open Access Status Not yet assessed
Volume 372
Issue 6
Start page 519
End page 527
Total pages 9
Place of publication Waltham, MA, United States
Publisher Massachussetts Medical Society
Collection year 2016
Language eng
Formatted abstract
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.
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2016 Collection
School of Medicine Publications
 
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