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Dominguez‐Rodriguez, Alberto; Abreu‐Gonzalez, Pedro; Torre‐Hernandez, Jose M.; Gonzalez‐Gonzalez, Julia; Garcia‐Camarero, Tamara; Consuegra‐Sanchez, Luciano; Garcia‐Saiz, Maria del Mar; Aldea‐Perona, Ana; Virgos‐Aller, Tirso; Azpeitia, Agueda; Reiter, Russel J.; Caballero‐Estevez, Natalia; Rosa, Alejandro; Nazco‐Casariego, Julia; Poderós, Teresa Giménez; Laynez‐Cerdeña, Ignacio; Bosa‐Ojeda, Francisco; Sanchez‐Grande, Alejandro; Yanes‐Bowden, Geoffrey; Vargas‐Torres, Manuel; Lara‐Padrón, Antonio; Perez‐Jorge, Pablo; Diaz‐Flores, Lucio; Lopez, Jorge; Lacalzada‐Almeida, Juan; Duque, Amelia; Bethencourt, Miguel; Izquierdo, Mariela; Juarez‐Prera, Ruben; Blanco‐Palacios, Gabriela; Barragan‐Acea, Antonio; Ferrer‐Hita, Julio; Marí‐Lopez, Belen; Padilla, Marta; Gonzalez, Esther; Martin‐Cabeza, Marta; Mendez‐Vargas, Corabel; Barrios, Patricia; Belleyo‐Belkasem, Carima; Leiva, Miguel; Betancor, Ivan; Miranda, Julio; Soria‐Arcos, Federico; Martinez, Lourdes
Journal of pineal research, January 2017, 2017-Jan, 2017-01-00, 20170101, Volume: 62, Issue: 1Journal Article
The MARIA randomized trial evaluated the efficacy and safety of melatonin for the reduction of reperfusion injury in patients undergoing revascularization for ST‐elevation myocardial infarction (STEMI). This was a prespecified interim analysis. A total of 146 patients presenting with STEMI within 6 hours of chest pain onset were randomized to receive intravenous and intracoronary melatonin (n=73) or placebo (n=73) during primary percutaneous coronary intervention (PPCI). Primary endpoint was myocardial infarct size as assessed by magnetic resonance imaging (MRI) at 6 ± 2 days. Secondary endpoints were changes in left ventricular volumes and ejection fraction (LVEF) at 130 ± 10 days post‐PPCI and adverse events during the first year. No significant differences in baseline characteristics were observed between groups. MRI was performed in 108 patients (86.4%). Myocardial infarct size by MRI evaluated 6 ± 2 days post‐PPCI, did not differ between melatonin and placebo groups (P=.63). Infarct size assessed by MRI at 130 ± 10 days post‐PPCI, performed in 91 patients (72.8%), did not show statistically significant differences between groups (P=.27). The recovery of LVEF from 6 ± 2 to 130 ± 10 days post‐PPCI was greater in the placebo group (60.0 ± 10.4% vs 53.1 ± 12.5%, P=.008). Both left ventricular end‐diastolic and end‐systolic volumes were lower in the placebo group (P=.01). The incidence of adverse events at 1 year was comparable in both groups (P=.150). Thus, in a nonrestricted STEMI population, intravenous and intracoronary melatonin was not associated with a reduction in infarct size and has an unfavourable effect on the ventricular volumes and LVEF evolution. Likewise, there is lack of toxicity of melatonin with the doses used.
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