Efficacy of a Device to Narrow the Coronary Sinus in Refractory Angina
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...
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| Format: | Article |
| Language: | en_US |
| Published: |
New England Journal of Medicine Group
2016
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| Online Access: | http://hdl.handle.net/1721.1/102789 https://orcid.org/0000-0002-7832-7156 |
| _version_ | 1826214339518922752 |
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| 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 |
| author2 | Institute for Medical Engineering and Science |
| author_facet | Institute for Medical Engineering and Science 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 |
| author_sort | Verheye, Stefan |
| collection | MIT |
| description | 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. |
| first_indexed | 2024-09-23T16:03:29Z |
| format | Article |
| id | mit-1721.1/102789 |
| institution | Massachusetts Institute of Technology |
| language | en_US |
| last_indexed | 2024-09-23T16:03:29Z |
| publishDate | 2016 |
| publisher | New England Journal of Medicine Group |
| record_format | dspace |
| spelling | mit-1721.1/1027892022-10-02T06:03:30Z 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. Banai, Shmuel Institute for Medical Engineering and Science Edelman, Elazer R. 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. Neovasc, Inc. (COSIRA ClinicalTrials.gov number, NCT01205893) 2016-06-01T18:54:49Z 2016-06-01T18:54:49Z 2015-02 Article http://purl.org/eprint/type/JournalArticle 0028-4793 1533-4406 http://hdl.handle.net/1721.1/102789 Verheye, Stefan, E. Marc Jolicœur, Miles W. Behan, Thomas Pettersson, Paul Sainsbury, Jonathan Hill, Mathias Vrolix, et al. “Efficacy of a Device to Narrow the Coronary Sinus in Refractory Angina.” N Engl J Med 372, no. 6 (February 5, 2015): 519–527. https://orcid.org/0000-0002-7832-7156 en_US http://dx.doi.org/10.1056/NEJMoa1402556 New England Journal of Medicine Article is made available in accordance with the publisher's policy and may be subject to US copyright law. Please refer to the publisher's site for terms of use. application/pdf New England Journal of Medicine Group New England Journal of Medicine |
| spellingShingle | 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 Efficacy of a Device to Narrow the Coronary Sinus in Refractory Angina |
| title | Efficacy of a Device to Narrow the Coronary Sinus in Refractory Angina |
| title_full | Efficacy of a Device to Narrow the Coronary Sinus in Refractory Angina |
| title_fullStr | Efficacy of a Device to Narrow the Coronary Sinus in Refractory Angina |
| title_full_unstemmed | Efficacy of a Device to Narrow the Coronary Sinus in Refractory Angina |
| title_short | Efficacy of a Device to Narrow the Coronary Sinus in Refractory Angina |
| title_sort | efficacy of a device to narrow the coronary sinus in refractory angina |
| url | http://hdl.handle.net/1721.1/102789 https://orcid.org/0000-0002-7832-7156 |
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