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

Alberto Dominguez-Rodriguez, Pedro Abreu-Gonzalez, Jose M. de la Torre-Hernandez, Julia Gonzalez-Gonzalez, Tamara Garcia-Camarero, Luciano Consuegra-Sanchez, Maria del Mar Garcia-Saiz, Ana Aldea-Perona, Tirso Virgos-Aller, Agueda Azpeitia, Russel J Reiter

Research output: Contribution to journalArticle

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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.

Original languageEnglish (US)
JournalJournal of Pineal Research
DOIs
StateAccepted/In press - 2016

Fingerprint

Melatonin
Percutaneous Coronary Intervention
Angioplasty
Myocardial Infarction
Placebos
Magnetic Resonance Imaging
Stroke Volume
Reperfusion Injury
Chest Pain
ST Elevation Myocardial Infarction
Safety
Incidence
Population

Keywords

  • Acute myocardial infarction
  • Heart ischaemia-reperfusion injury
  • Infarct size
  • Melatonin
  • Mitochondria
  • Primary angioplasty

ASJC Scopus subject areas

  • Endocrinology

Cite this

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. / Dominguez-Rodriguez, Alberto; Abreu-Gonzalez, Pedro; de la 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.

In: Journal of Pineal Research, 2016.

Research output: Contribution to journalArticle

Dominguez-Rodriguez, Alberto ; Abreu-Gonzalez, Pedro ; de la 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. / 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. In: Journal of Pineal Research. 2016.
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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.",
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author = "Alberto Dominguez-Rodriguez and Pedro Abreu-Gonzalez and {de la Torre-Hernandez}, {Jose M.} and Julia Gonzalez-Gonzalez and Tamara Garcia-Camarero and Luciano Consuegra-Sanchez and Garcia-Saiz, {Maria del Mar} and Ana Aldea-Perona and Tirso Virgos-Aller and Agueda Azpeitia and Reiter, {Russel J}",
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T1 - Effect of intravenous and intracoronary melatonin as an adjunct to primary percutaneous coronary intervention for acute ST-elevation myocardial infarction

T2 - Results of the Melatonin Adjunct in the acute myocaRdial Infarction treated with Angioplasty trial

AU - Dominguez-Rodriguez, Alberto

AU - Abreu-Gonzalez, Pedro

AU - de la Torre-Hernandez, Jose M.

AU - Gonzalez-Gonzalez, Julia

AU - Garcia-Camarero, Tamara

AU - Consuegra-Sanchez, Luciano

AU - Garcia-Saiz, Maria del Mar

AU - Aldea-Perona, Ana

AU - Virgos-Aller, Tirso

AU - Azpeitia, Agueda

AU - Reiter, Russel J

PY - 2016

Y1 - 2016

N2 - 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.

AB - 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.

KW - Acute myocardial infarction

KW - Heart ischaemia-reperfusion injury

KW - Infarct size

KW - Melatonin

KW - Mitochondria

KW - Primary angioplasty

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