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
Аннотация
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.).