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Cyclosporine before PCI in Patients with Acute Myocardial Infarction

Thien-Tri Cung 1 Olivier Morel 2 Guillaume Cayla 3, 4 Gilles Rioufol 5 David Garcia-Dorado Denis Angoulvant 6 Eric Bonnefoy-Cudraz 5 Patrice Guérin Meier Elbaz Nicolas Delarche Pierre Coste 7, 8 Gérald Vanzetto 9 Marc Metge Jean-François Aupetit Bernard Jouve Pascal Motreff Christophe Tron 10 Jean-Noel Labeque Philippe Gabriel Steg 11, 12 Yves Cottin 13, 14 Grégoire Range Jérome Clerc Marc J. Claeys Patrick Coussement Fabrice Prunier 15, 16 Frédéric Moulin 17 Olivier Roth Loic Belle 18 Philippe Dubois Paul Barragan 19 Martine Gilard 20 Christophe Piot 21 Patrice Colin Fabien de Poli Marie-Claude Morice Omar Ider Jean-Luc Dubois-Randé 22 Thierry Unterseeh Hervé Le Breton 23, 24 Thierry Béard Didier Blanchard 25 Gilles Grollier Vincent Malquarti Patrick Staat Arnaud Sudre Eskil Elmer Magnus J. Hansson Cyrille Bergerot 26 Inesse Boussaha Claire Jossan Geneviève Derumeaux 27 Nathan Mewton 5 Michel Ovize 28
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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Submitted on : Friday, January 22, 2016 - 1:04:41 PM
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Thien-Tri Cung, Olivier Morel, Guillaume Cayla, Gilles Rioufol, David Garcia-Dorado, et al.. Cyclosporine before PCI in Patients with Acute Myocardial Infarction. New England Journal of Medicine, Massachusetts Medical Society, 2015, 373 (11), pp.1021--1031. ⟨10.1056/NEJMoa1505489⟩. ⟨hal-01260566⟩

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