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Cyclosporine before PCI in Patients with Acute Myocardial Infarction

Cung, T. -T.; Morel, O.; Cayla, G.; Rioufol, G.; Garcia-Dorado, D.; Angoulvant, D.; Bonnefoy-Cudraz, E.; Guerin, P.; Elbaz, M. and Delarche, N., et al. (2015) In New England Journal of Medicine 373(11). p.1021-1031
Abstract
BACKGROUND Experimental and clinical evidence suggests that cyclosporine may attenuate reperfusion injury and reduce myocardial infarct size. We aimed to test whether cyclosporine would improve clinical outcomes and prevent adverse left ventricular remodeling. METHODS In a multicenter, double-blind, randomized trial, we assigned 970 patients with an acute anterior ST-segment elevation myocardial infarction (STEMI) who were undergoing percutaneous coronary intervention (PCI) within 12 hours after symptom onset and who had complete occlusion of the culprit coronary artery to receive a bolus injection of cyclosporine (administered intravenously at a dose of 2.5 mg per kilogram of body weight) or matching placebo before coronary... (More)
BACKGROUND Experimental and clinical evidence suggests that cyclosporine may attenuate reperfusion injury and reduce myocardial infarct size. We aimed to test whether cyclosporine would improve clinical outcomes and prevent adverse left ventricular remodeling. METHODS In a multicenter, double-blind, randomized trial, we assigned 970 patients with an acute anterior ST-segment elevation myocardial infarction (STEMI) who were undergoing percutaneous coronary intervention (PCI) within 12 hours after symptom onset and who had complete occlusion of the culprit coronary artery to receive a bolus injection of cyclosporine (administered intravenously at a dose of 2.5 mg per kilogram of body weight) or matching placebo before coronary recanalization. The primary outcome was a composite of death from any cause, worsening of heart failure during the initial hospitalization, rehospitalization for heart failure, or adverse left ventricular remodeling at 1 year. Adverse left ventricular remodeling was defined as an increase of 15% or more in the left ventricular end-diastolic volume. RESULTS A total of 395 patients in the cyclosporine group and 396 in the placebo group received the assigned study drug and had data that could be evaluated for the primary outcome at 1 year. The rate of the primary outcome was 59.0% in the cyclosporine group and 58.1% in the control group (odds ratio, 1.04; 95% confidence interval, 0.78 to 1.39; P = 0.77). Cyclosporine did not reduce the incidence of the separate clinical components of the primary outcome or other events, including recurrent infarction, unstable angina, and stroke. No significant difference in the safety profile was observed between the two treatment groups. CONCLUSIONS In patients with anterior STEMI who had been referred for primary PCI, intravenous cyclosporine did not result in better clinical outcomes than those with placebo and did not prevent adverse left ventricular remodeling at 1 year. (Funded by the French Ministry of Health and NeuroVive Pharmaceutical; CIRCUS ClinicalTrials.gov number, NCT01502774; EudraCT number, 2009-013713-99.) (Less)
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New England Journal of Medicine
volume
373
issue
11
pages
1021 - 1031
publisher
Massachusetts Medical Society
external identifiers
  • wos:000360959000007
  • scopus:84941308478
ISSN
0028-4793
DOI
10.1056/NEJMoa1505489
language
English
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yes
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1ed1e498-272a-41a1-9bd1-af6fddd4a7ae (old id 8077486)
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2015-10-26 13:49:29
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2017-11-12 03:06:31
@article{1ed1e498-272a-41a1-9bd1-af6fddd4a7ae,
  abstract     = {BACKGROUND Experimental and clinical evidence suggests that cyclosporine may attenuate reperfusion injury and reduce myocardial infarct size. We aimed to test whether cyclosporine would improve clinical outcomes and prevent adverse left ventricular remodeling. METHODS In a multicenter, double-blind, randomized trial, we assigned 970 patients with an acute anterior ST-segment elevation myocardial infarction (STEMI) who were undergoing percutaneous coronary intervention (PCI) within 12 hours after symptom onset and who had complete occlusion of the culprit coronary artery to receive a bolus injection of cyclosporine (administered intravenously at a dose of 2.5 mg per kilogram of body weight) or matching placebo before coronary recanalization. The primary outcome was a composite of death from any cause, worsening of heart failure during the initial hospitalization, rehospitalization for heart failure, or adverse left ventricular remodeling at 1 year. Adverse left ventricular remodeling was defined as an increase of 15% or more in the left ventricular end-diastolic volume. RESULTS A total of 395 patients in the cyclosporine group and 396 in the placebo group received the assigned study drug and had data that could be evaluated for the primary outcome at 1 year. The rate of the primary outcome was 59.0% in the cyclosporine group and 58.1% in the control group (odds ratio, 1.04; 95% confidence interval, 0.78 to 1.39; P = 0.77). Cyclosporine did not reduce the incidence of the separate clinical components of the primary outcome or other events, including recurrent infarction, unstable angina, and stroke. No significant difference in the safety profile was observed between the two treatment groups. CONCLUSIONS In patients with anterior STEMI who had been referred for primary PCI, intravenous cyclosporine did not result in better clinical outcomes than those with placebo and did not prevent adverse left ventricular remodeling at 1 year. (Funded by the French Ministry of Health and NeuroVive Pharmaceutical; CIRCUS ClinicalTrials.gov number, NCT01502774; EudraCT number, 2009-013713-99.)},
  author       = {Cung, T. -T. and Morel, O. and Cayla, G. and Rioufol, G. and Garcia-Dorado, D. and Angoulvant, D. and Bonnefoy-Cudraz, E. and Guerin, P. and Elbaz, M. and Delarche, N. and Coste, P. and Vanzetto, G. and Metge, M. and Aupetit, J. -F. and Jouve, B. and Motreff, P. and Tron, C. and Labeque, J. -N. and Steg, P. G. and Cottin, Y. and Range, G. and Clerc, J. and Claeys, M. J. and Coussement, P. and Prunier, F. and Moulin, F. and Roth, O. and Belle, L. and Dubois, P. and Barragan, P. and Gilard, M. and Piot, C. and Colin, P. and De Poli, F. and Morice, M. -C. and Ider, O. and Dubois-Rande, J. -L. and Unterseeh, T. and Le Breton, H. and Beard, T. and Blanchard, D. and Grollier, G. and Malquarti, V. and Staat, P. and Sudre, A. and Elmer, Eskil and Hansson, Magnus and Bergerot, C. and Boussaha, I. and Jossan, C. and Derumeaux, G. and Mewton, N. and Ovize, M.},
  issn         = {0028-4793},
  language     = {eng},
  number       = {11},
  pages        = {1021--1031},
  publisher    = {Massachusetts Medical Society},
  series       = {New England Journal of Medicine},
  title        = {Cyclosporine before PCI in Patients with Acute Myocardial Infarction},
  url          = {http://dx.doi.org/10.1056/NEJMoa1505489},
  volume       = {373},
  year         = {2015},
}