Rebecca Mathew1, Pietro Di Santo1, Richard G Jung1, Jeffrey A Marbach1, Jordan Hutson1, Trevor Simard1, F Daniel Ramirez1, David T Harnett1, Anas Merdad1, Aws Almufleh1, Willy Weng1, Omar Abdel-Razek1, Shannon M Fernando1, Kwadwo Kyeremanteng1, Jordan Bernick1, George A Wells1, Vincent Chan1, Michael Froeschl1, Marino Labinaz1, Michel R Le May1, Juan J Russo1, Benjamin Hibbert1. 1. From the CAPITAL Research Group, Division of Cardiology (R.M., P.D.S., R.G.J., J.A.M., T.S., F.D.R., D.T.H., O.A.-R., M.F., M.L., M.R.L.M., J.J.R., B.H.), the Cardiovascular Research Methods Centre (J.B., G.A.W.), and the Division of Cardiac Surgery (V.C.), University of Ottawa Heart Institute, and the Faculty of Medicine (R.M., P.D.S., R.G.J., J.H., D.T.H., W.W., O.A.-R., S.M.F., K.K., M.F., M.L., M.R.L.M., J.J.R., B.H.), the Division of Critical Care, Department of Medicine (R.M., J.H., S.M.F., K.K.), the School of Epidemiology and Public Health (P.D.S.), and the Department of Cellular and Molecular Medicine (R.G.J., T.S., B.H.), University of Ottawa, Ottawa, the Division of Cardiology, University of Toronto, Toronto (A.M.), and the Division of Cardiology, University of British Columbia, Vancouver (A.A.) - all in Canada; the Division of Critical Care, Tufts Medical Center, Boston (J.A.M.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (T.S.); and Hôpital Cardiologique du Haut Lévêque, Centre Hospitalier Universitaire Bordeaux (F.D.R.), and LIRYC (L'Institut de Rythmologie et Modélisation Cardiaque) (F.D.R.) - both in Bordeaux-Pessac, France.
Abstract
BACKGROUND:Cardiogenic shock is associated with substantial morbidity and mortality. Although inotropic support is a mainstay of medical therapy for cardiogenic shock, little evidence exists to guide the selection of inotropic agents in clinical practice. METHODS: We randomly assigned patients with cardiogenic shock to receive milrinone or dobutamine in a double-blind fashion. The primary outcome was a composite of in-hospital death from any cause, resuscitated cardiac arrest, receipt of a cardiac transplant or mechanical circulatory support, nonfatal myocardial infarction, transient ischemic attack or stroke diagnosed by a neurologist, or initiation of renal replacement therapy. Secondary outcomes included the individual components of the primary composite outcome. RESULTS: A total of 192 participants (96 in each group) were enrolled. The treatment groups did not differ significantly with respect to the primary outcome; a primary outcome event occurred in 47 participants (49%) in the milrinone group and in 52 participants (54%) in the dobutamine group (relative risk, 0.90; 95% confidence interval [CI], 0.69 to 1.19; P = 0.47). There were also no significant differences between the groups with respect to secondary outcomes, including in-hospital death (37% and 43% of the participants, respectively; relative risk, 0.85; 95% CI, 0.60 to 1.21), resuscitated cardiac arrest (7% and 9%; hazard ratio, 0.78; 95% CI, 0.29 to 2.07), receipt of mechanical circulatory support (12% and 15%; hazard ratio, 0.78; 95% CI, 0.36 to 1.71), or initiation of renal replacement therapy (22% and 17%; hazard ratio, 1.39; 95% CI, 0.73 to 2.67). CONCLUSIONS: In patients with cardiogenic shock, no significant difference between milrinone and dobutamine was found with respect to the primary composite outcome or important secondary outcomes. (Funded by the Innovation Fund of the Alternative Funding Plan for the Academic Health Sciences Centres of Ontario; ClinicalTrials.gov number, NCT03207165.).
RCT Entities:
BACKGROUND:Cardiogenic shock is associated with substantial morbidity and mortality. Although inotropic support is a mainstay of medical therapy for cardiogenic shock, little evidence exists to guide the selection of inotropic agents in clinical practice. METHODS: We randomly assigned patients with cardiogenic shock to receive milrinone or dobutamine in a double-blind fashion. The primary outcome was a composite of in-hospital death from any cause, resuscitated cardiac arrest, receipt of a cardiac transplant or mechanical circulatory support, nonfatal myocardial infarction, transient ischemic attack or stroke diagnosed by a neurologist, or initiation of renal replacement therapy. Secondary outcomes included the individual components of the primary composite outcome. RESULTS: A total of 192 participants (96 in each group) were enrolled. The treatment groups did not differ significantly with respect to the primary outcome; a primary outcome event occurred in 47 participants (49%) in the milrinone group and in 52 participants (54%) in the dobutamine group (relative risk, 0.90; 95% confidence interval [CI], 0.69 to 1.19; P = 0.47). There were also no significant differences between the groups with respect to secondary outcomes, including in-hospital death (37% and 43% of the participants, respectively; relative risk, 0.85; 95% CI, 0.60 to 1.21), resuscitated cardiac arrest (7% and 9%; hazard ratio, 0.78; 95% CI, 0.29 to 2.07), receipt of mechanical circulatory support (12% and 15%; hazard ratio, 0.78; 95% CI, 0.36 to 1.71), or initiation of renal replacement therapy (22% and 17%; hazard ratio, 1.39; 95% CI, 0.73 to 2.67). CONCLUSIONS: In patients with cardiogenic shock, no significant difference between milrinone and dobutamine was found with respect to the primary composite outcome or important secondary outcomes. (Funded by the Innovation Fund of the Alternative Funding Plan for the Academic Health Sciences Centres of Ontario; ClinicalTrials.gov number, NCT03207165.).
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