Cited by 714Cardiac Ischemia and ReperfusionAcute Myocardial Infarction ResearchCardiac Fibrosis and Remodeling

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Cyclosporine before PCI in Patients with Acute Myocardial Infarction

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Cung, Thien-Tri, Morel, Olivier, Cayla, Guillaume, Rioufol, Gilles, Garcia-Dorado, David, Angoulvant, Denis, Bonnefoy-Cudraz, Eric, Guérin, Patrice, Elbaz, Meier, Delarche, Nicolas, Coste, Pierre, Vanzetto, Gerald, Metge, Marc, Aupetit, Jean-François, Jouve, Bernard, Motreff, Pascal, Tron, Christophe, Labeque, Jean-Noel, Steg, Philippe Gabriel, Cottin, Yves, Range, Grégoire, Clerc, Jérome, Claeys, Marc J., Coussement, Patrick, Prunier, Fabrice, Moulin, Frédéric, Roth, Olivier, Belle, Loïc, Dubois, Philippe, Barragan, Paul, Gilard, Martine, Piot, Christophe, Colin, Patrice, De Poli, Fabien, Morice, Marie-Claude, Ider, Omar, Dubois-Randé, Jean-Luc, Unterseeh, Thierry, Le Breton, Hervé, Béard, Thierry, Blanchard, Didier, Grollier, Gilles, Malquarti, Vincent, Staat, Patrick, Sudre, Arnaud, Elmer, Eskil, Hansson, Magnus J., Bergerot, Cyrille, Boussaha, Inesse, Jossan, Claire, Derumeaux, Geneviève, Mewton, Nathan, Ovize, Michel·2015·New England Journal of Medicine

DOI 10.1056/nejmoa1505489

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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 [CI], 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.).

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Authors: Cung, T.-T., Morel, O., Cayla, G., Rioufol, G., Garcia-Dorado, D., Angoulvant, D., Bonnefoy-Cudraz, E., Guérin, P., Elbaz, M., Delarche, N., Coste, P., Vanzetto, G., Metge, M., Aupetit, J.-F., Jouve, B., Motreff, P., Tron, C., Labeque, J.-N., Steg, P. G., Cottin, Y., Range, G., Clerc, J., Claeys, M. J., Coussement, P., Prunier, F., Moulin, F., Roth, O., Belle, L., Dubois, P., Barragan, P., Gilard, M., Piot, C., Colin, P., De Poli, F., Morice, M.-C., Ider, O., Dubois-Randé, J.-L., Unterseeh, T., Le Breton, H., Béard, T., Blanchard, D., Grollier, G., Malquarti, V., Staat, P., Sudre, A., Elmer, E., Hansson, M. J., Bergerot, C., Boussaha, I., Jossan, C., Derumeaux, G., Mewton, N., & Ovize, M.
Affiliations: Centre Hospitalier Universitaire de Nantes (FR)
Hôpitaux Universitaires de Strasbourg (FR)
Centre Hospitalier Universitaire de Nîmes (FR)
Lyon 1 Université (FR)
Centre Hospitalier De Pau (FR)
Centre Hospitalier Universitaire de Bordeaux (FR)
Centre Hospitalier Saint-Joseph Saint-Luc (FR)
Centre Hospitalier Intercommunal Aix-Pertuis (FR)
Centre Hospitalier Universitaire de Clermont-Ferrand (FR)
Hôpital Charles-Nicolle (FR)
CHU Dijon Bourgogne (FR)
Antwerp University Hospital (BE)
AZ Sint-Jan (BE)
Centre Hospitalier Universitaire d'Angers (FR)
Centre Hospitalier Régional et Universitaire de Nancy (FR)
Centre Hospitalier de Mulhouse (FR)
HUmani - CHU Charleroi-Chimay (BE)
Clinique du Millénaire (FR)
Hôpital Privé Jacques Cartier (FR)
Centre Hospitalier Universitaire de Caen Normandie (FR)
Lille’s Cardiology Hospital (FR)
Lund University (SE)
ORCID: Morel, Olivier
Cayla, Guillaume
Rioufol, Gilles
Angoulvant, Denis
Guérin, Patrice
Delarche, Nicolas
Coste, Pierre
Motreff, Pascal
Tron, Christophe
Cottin, Yves
Claeys, Marc J.
Prunier, Fabrice
Barragan, Paul
Gilard, Martine
Piot, Christophe
Unterseeh, Thierry
Sudre, Arnaud
Hansson, Magnus J.
Bergerot, Cyrille
Jossan, Claire
Mewton, Nathan
Ovize, Michel
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2015-09-10
Volume: 373
Issue: 11
Pages: 1021-1031
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa1505489
OpenAlex: W2200357463
Cited by: 713
References: 34
Citations by year: 2026: 38 · 2025: 46 · 2024: 48 · 2023: 55 · 2022: 62 · 2021: 57 · 2020: 75 · 2019: 79 · 2018: 70 · 2017: 70 · 2016: 92 · 2015: 20
FWCI: 66.66
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
HAL (submittedVersion, other-oa)
HAL (submittedVersion)
Lund University Publications (Lund University) (submittedVersion)
Spiral (Imperial College London) (submittedVersion)
Funders: Lunds Universitet
Assistance publique-Hôpitaux de Paris
Universitair Ziekenhuis Antwerpen
Topics: Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac Ischemia and Reperfusion
Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Acute Myocardial Infarction Research
Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac Fibrosis and Remodeling
Keywords: cyclosporine, ST-elevation myocardial infarction, percutaneous coronary intervention, left ventricular remodeling, ischemia-reperfusion injury, myocardial infarct size, heart failure, intravenous cyclosporine, primary percutaneous coronary intervention, drug safety
MeSH terms: Peptidyl-Prolyl Isomerase D, Aged, Combined Modality Therapy, Double-Blind Method, Electrocardiography, Enzyme Inhibitors, Female, Heart Failure, Humans, Injections, Intravenous, Male, Middle Aged, Mortality, Myocardial Infarction, Cyclosporine, Ventricular Remodeling, Cyclophilins, Kaplan-Meier Estimate, Percutaneous Coronary Intervention

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Cyclosporine before PCI in Patients with Acute Myocardial Infarction

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