Cyclosporine before PCI in Patients with Acute Myocardial Infarction
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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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Despite multiple clinical trials, no drug based on interrupting RCD signaling after initiation has been approved for use in humans by regulatory agencies.
“with relatively deceiving results (despite multiple clinical trials, no drug based on this concept has ever been approved for use in humans by regulatory agencies) [387].”
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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
- 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 › Pathology and Forensic 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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