title: Effect of intravenous and intracoronary melatonin as an adjunct to primary percutaneous coronary intervention for acute ST-elevation myocardial infarction: Results of the Melatonin Adjunct in the acute myocaRdial Infarction treated with Angioplasty trial.
abstract: 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.
authors.affiliation: Department of Cardiology, Hospital Universitario de Canarias, Santa Cruz de Tenerife, Spain.|Facultad de Ciencias de la Salud, Universidad Europea de Canarias, La Orotava, Santa Cruz de Tenerife, Spain.
authors.forename: Alberto
authors.initials: A
authors.lastname: Dominguez-Rodriguez
authors.affiliation: Departamento de Ciencias Médicas Básicas (Unidad de Fisiología), Universidad de La Laguna, Santa Cruz de Tenerife, Spain.
authors.forename: Pedro
authors.initials: P
authors.lastname: Abreu-Gonzalez
authors.affiliation: Department of Cardiology, Hospital Universitario Marques de Valdecilla, Santander, Cantabria, Spain.
authors.forename: Jose M
authors.initials: JM
authors.lastname: de la Torre-Hernandez
authors.affiliation: Department of Cardiology, Hospital Universitario de Canarias, Santa Cruz de Tenerife, Spain.
authors.forename: Julia
authors.initials: J
authors.lastname: Gonzalez-Gonzalez
authors.affiliation: Department of Cardiology, Hospital Universitario Marques de Valdecilla, Santander, Cantabria, Spain.
authors.forename: Tamara
authors.initials: T
authors.lastname: Garcia-Camarero
authors.affiliation: Department of Cardiology, Hospital Universitario de Santa Lucia, Murcia, Spain.
authors.forename: Luciano
authors.initials: L
authors.lastname: Consuegra-Sanchez
authors.affiliation: Department of Pharmacology, Hospital Universitario de Canarias, Santa Cruz de Tenerife, Spain.
authors.forename: Maria Del Mar
authors.initials: MD
authors.lastname: Garcia-Saiz
authors.affiliation: Department of Pharmacology, Hospital Universitario de Canarias, Santa Cruz de Tenerife, Spain.
authors.forename: Ana
authors.initials: A
authors.lastname: Aldea-Perona
authors.affiliation: Department of Pharmacy, Hospital Universitario de Canarias, Santa Cruz de Tenerife, Spain.
authors.forename: Tirso
authors.initials: T
authors.lastname: Virgos-Aller
authors.affiliation: Onmedic Networks, Barcelona, Spain.
authors.forename: Agueda
authors.initials: A
authors.lastname: Azpeitia
authors.affiliation: Department of Cellular and Structural Biology, University of Texas Health Science Center, San Antonio, TX, USA.
authors.forename: Russel J
authors.initials: RJ
authors.lastname: Reiter
mesh_terms: D015906:Angioplasty, Balloon, Coronary; D005260:Female; D006801:Humans; D008297:Male; D008550:Melatonin / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D015428:Myocardial Reperfusion Injury / Q000517:prevention & control*; D000072657:ST Elevation Myocardial Infarction / Q000628:therapy*
chemical_list: D008550:Melatonin
keywords: acute myocardial infarction; heart ischaemia-reperfusion injury; infarct size; melatonin; mitochondria; primary angioplasty