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 Edelman; Shmuel Banai

doi:10.1056/NEJMoa1402556

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

242 Citationer (Scopus)

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. (Funded by Neovasc; COSIRA ClinicalTrials.gov number, NCT01205893.).

Originalsprog	Engelsk
Tidsskrift	The New England journal of medicine
Vol/bind	372
Udgave nummer	6
Sider (fra-til)	519-27
Antal sider	9
ISSN	0028-4793
DOI	https://doi.org/10.1056/NEJMoa1402556
Status	Udgivet - 5 feb. 2015

Adgang til dokumentet

10.1056/NEJMoa1402556

Citationsformater

Verheye, S., Jolicœur, E. M., Behan, M. W., Pettersson, T., Sainsbury, P., Hill, J., Vrolix, M., Agostoni, P., Engstrom, T., Labinaz, M., de Silva, R., Schwartz, M., Meyten, N., Uren, N. G., Doucet, S., Tanguay, J.-F., Lindsay, S., Henry, T. D., White, C. J., ... Banai, S. (2015). Efficacy of a device to narrow the coronary sinus in refractory angina. The New England journal of medicine, 372(6), 519-27. https://doi.org/10.1056/NEJMoa1402556

Verheye, S, Jolicœur, EM, Behan, MW, Pettersson, T, Sainsbury, P, Hill, J, Vrolix, M, Agostoni, P, Engstrom, T, Labinaz, M, de Silva, R, Schwartz, M, Meyten, N, Uren, NG, Doucet, S, Tanguay, J-F, Lindsay, S, Henry, TD, White, CJ, Edelman, ER & Banai, S 2015, 'Efficacy of a device to narrow the coronary sinus in refractory angina', The New England journal of medicine, bind 372, nr. 6, s. 519-27. https://doi.org/10.1056/NEJMoa1402556

@article{03161ae78489484aaecad2cbeb6f48f2,

title = "Efficacy of a device to narrow the coronary sinus in refractory angina",

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. (Funded by Neovasc; COSIRA ClinicalTrials.gov number, NCT01205893.).",

keywords = "Adult, Aged, Aged, 80 and over, Angina Pectoris, Cardiac Catheterization, Cardiac Catheters, Coronary Angiography, Coronary Sinus, Equipment Design, Female, Humans, Male, Middle Aged, Myocardial Revascularization, Patient Acuity, Quality of Life, Surgical Mesh",

author = "Stefan Verheye and Jolic{\oe}ur, {E Marc} and Behan, {Miles W} and Thomas Pettersson and Paul Sainsbury and Jonathan Hill and Mathias Vrolix and Pierfrancesco Agostoni and Thomas Engstrom and Marino Labinaz and {de Silva}, Ranil and Marc Schwartz and Nathalie Meyten and Uren, {Neal G} and Serge Doucet and Jean-Fran{\c c}ois Tanguay and Steven Lindsay and Henry, {Timothy D} and White, {Christopher J} and Edelman, {Elazer R} and Shmuel Banai",

year = "2015",

month = feb,

day = "5",

doi = "10.1056/NEJMoa1402556",

language = "English",

volume = "372",

pages = "519--27",

journal = "The New England journal of medicine",

issn = "0028-4793",

publisher = "Massachusetts Medical Society",

number = "6",

}

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

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 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.).

AB - 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.).

KW - Adult

KW - Aged

KW - Aged, 80 and over

KW - Angina Pectoris

KW - Cardiac Catheterization

KW - Cardiac Catheters

KW - Coronary Angiography

KW - Coronary Sinus

KW - Equipment Design

KW - Female

KW - Humans

KW - Male

KW - Middle Aged

KW - Myocardial Revascularization

KW - Patient Acuity

KW - Quality of Life

KW - Surgical Mesh

U2 - 10.1056/NEJMoa1402556

DO - 10.1056/NEJMoa1402556

M3 - Journal article

C2 - 25651246

SN - 0028-4793

VL - 372

SP - 519

EP - 527

JO - The New England journal of medicine

JF - The New England journal of medicine

IS - 6

ER -

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

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