Bruno Levy1, Raphael Clere-Jehl2, Annick Legras3, Tristan Morichau-Beauchant4, Marc Leone5, Ganster Frederique6, Jean-Pierre Quenot7, Antoine Kimmoun8, Alain Cariou4, Johan Lassus9, Veli-Pekka Harjola9, Ferhat Meziani2, Guillaume Louis10, Patrick Rossignol11, Kevin Duarte11, Nicolas Girerd11, Alexandre Mebazaa12, Philippe Vignon13. 1. Service de Réanimation Médicale Brabois, CHRU Nancy, Pôle Cardio-Médico-Chirurgical, Vandoeuvre-les-Nancy, INSERM U1116, Faculté de Médecine, Vandoeuvre-les-Nancy, and Université de Lorraine, Nancy, France. Electronic address: blevy5463@gmail.com. 2. Université de Strasbourg (UNISTRA), Faculté de médecine, Hôpitaux Universitaires de Strasbourg, Service de réanimation, Nouvel Hôpital Civil, Strasbourg, France. 3. Médecine Intensive Réanimation, CHRU Bretonneau, Tours, France. 4. Medical ICU, Cochin University Hospital (APHP), Paris, France, and Paris Descartes University, Paris, France. 5. Surgical ICU, Hôpital Nord, AP-HM, Aix Marseille Université, Marseille, France. 6. Service de Réanimation Médicale, Groupement Hospitalier Mulhouse Sud Alsace-Hôpital Emile Muller, Mulhouse, France. 7. Department of Intensive Care, François Mitterrand University Hospital, Dijon, Lipness Team, INSERM Research Center LNC-UMR1231 and LabExLipSTIC, University of Burgundy, Dijon, and INSERM CIC 1432, Clinical Epidemiology, University of Burgundy, Dijon, France. 8. Service de Réanimation Médicale Brabois, CHRU Nancy, Pôle Cardio-Médico-Chirurgical, Vandoeuvre-les-Nancy, INSERM U1116, Faculté de Médecine, Vandoeuvre-les-Nancy, and Université de Lorraine, Nancy, France. 9. Heart and Lung Center, Cardiology, Helsinki University and Helsinki University Hospital, Helsinki, Finland. 10. Service de Réanimation, Hôpital Mercy, Metz, France. 11. INSERM CIC1433, Nancy University Hospital, Nancy, France. 12. Inserm UMR-S 942, Hôpital Lariboisière, Paris, Department of Anaesthesiology and Intensive Care, Lariboisière Hospital, and Université Paris Diderot-Sorbonne Paris Cité, Paris, France. 13. Medical-Surgical Intensive Care Unit, Teaching Hospital of Limoges, Limoges, and INSERM CIC 1435, Teaching Hospital of Limoges, Limoges, France.
Abstract
BACKGROUND: Vasopressor agents could have certain specific effects in patients with cardiogenic shock (CS) after myocardial infarction, which may influence outcome. Although norepinephrine and epinephrine are currently the most commonly used agents, no randomized trial has compared their effects, and intervention data are lacking. OBJECTIVES: The goal of this paper was to compare in a prospective, double-blind, multicenter, randomized study, the efficacy and safety of epinephrine and norepinephrine in patients with CS after acute myocardial infarction. METHODS: The primary efficacy outcome was cardiac index evolution, and the primary safety outcome was the occurrence of refractory CS. Refractory CS was defined as CS with sustained hypotension, end-organ hypoperfusion and hyperlactatemia, and high inotrope and vasopressor doses. RESULTS:Fifty-seven patients were randomized into 2 study arms, epinephrine and norepinephrine. For the primary efficacy endpoint, cardiac index evolution was similar between the 2 groups (p = 0.43) from baseline (H0) to H72. For the main safety endpoint, the observed higher incidence of refractory shock in the epinephrine group (10 of 27 [37%] vs. norepinephrine 2 of 30 [7%]; p = 0.008) led to early termination of the study. Heart rate increased significantly with epinephrine from H2 to H24 while remaining unchanged with norepinephrine (p < 0.0001). Several metabolic changes were unfavorable to epinephrine compared with norepinephrine, including an increase in cardiac double product (p = 0.0002) and lactic acidosis from H2 to H24 (p < 0.0001). CONCLUSIONS: In patients with CS secondary to acute myocardial infarction, the use of epinephrine compared with norepinephrine was associated with similar effects on arterial pressure and cardiac index and a higher incidence of refractory shock. (Study Comparing the Efficacy and Tolerability of Epinephrine and Norepinephrine in Cardiogenic Shock [OptimaCC]; NCT01367743).
RCT Entities:
BACKGROUND: Vasopressor agents could have certain specific effects in patients with cardiogenic shock (CS) after myocardial infarction, which may influence outcome. Although norepinephrine and epinephrine are currently the most commonly used agents, no randomized trial has compared their effects, and intervention data are lacking. OBJECTIVES: The goal of this paper was to compare in a prospective, double-blind, multicenter, randomized study, the efficacy and safety of epinephrine and norepinephrine in patients with CS after acute myocardial infarction. METHODS: The primary efficacy outcome was cardiac index evolution, and the primary safety outcome was the occurrence of refractory CS. Refractory CS was defined as CS with sustained hypotension, end-organ hypoperfusion and hyperlactatemia, and high inotrope and vasopressor doses. RESULTS: Fifty-seven patients were randomized into 2 study arms, epinephrine and norepinephrine. For the primary efficacy endpoint, cardiac index evolution was similar between the 2 groups (p = 0.43) from baseline (H0) to H72. For the main safety endpoint, the observed higher incidence of refractory shock in the epinephrine group (10 of 27 [37%] vs. norepinephrine 2 of 30 [7%]; p = 0.008) led to early termination of the study. Heart rate increased significantly with epinephrine from H2 to H24 while remaining unchanged with norepinephrine (p < 0.0001). Several metabolic changes were unfavorable to epinephrine compared with norepinephrine, including an increase in cardiac double product (p = 0.0002) and lactic acidosis from H2 to H24 (p < 0.0001). CONCLUSIONS: In patients with CS secondary to acute myocardial infarction, the use of epinephrine compared with norepinephrine was associated with similar effects on arterial pressure and cardiac index and a higher incidence of refractory shock. (Study Comparing the Efficacy and Tolerability of Epinephrine and Norepinephrine in Cardiogenic Shock [OptimaCC]; NCT01367743).
Authors: Manal Alasnag; Alexander G Truesdell; Holli Williams; Sara C Martinez; Syeda Kashfi Qadri; John P Skendelas; William A Jakobleff; Mirvat Alasnag Journal: Curr Atheroscler Rep Date: 2020-04-23 Impact factor: 5.113
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Authors: Christoph Maack; Thomas Eschenhagen; Nazha Hamdani; Frank R Heinzel; Alexander R Lyon; Dietmar J Manstein; Joseph Metzger; Zoltán Papp; Carlo G Tocchetti; M Birhan Yilmaz; Stefan D Anker; Jean-Luc Balligand; Johann Bauersachs; Dirk Brutsaert; Lucie Carrier; Stefan Chlopicki; John G Cleland; Rudolf A de Boer; Alexander Dietl; Rodolphe Fischmeister; Veli-Pekka Harjola; Stephane Heymans; Denise Hilfiker-Kleiner; Johannes Holzmeister; Gilles de Keulenaer; Giuseppe Limongelli; Wolfgang A Linke; Lars H Lund; Josep Masip; Marco Metra; Christian Mueller; Burkert Pieske; Piotr Ponikowski; Arsen Ristić; Frank Ruschitzka; Petar M Seferović; Hadi Skouri; Wolfram H Zimmermann; Alexandre Mebazaa Journal: Eur Heart J Date: 2019-11-21 Impact factor: 29.983