Dobutamine Compared With Milrinone - DOREMI

Aug 18, 2021
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC; Neil Keshvani, MD
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Innovation Fund of the Alternative Funding Plan for the Academic Health Sciences Centres of Ontario
Date Published:
08/04/2021
Date Updated:
08/18/2021
Original Posted Date:
08/18/2021
References

Contribution To Literature:

The DOREMI trial showed that, among patients with cardiogenic shock, there were no significant differences in cardiovascular or renal outcomes between intravenous milrinone and dobutamine.

Description:

The goal of the trial was to compare the efficacy and safety of milrinone and dobutamine in patients with cardiogenic shock. 

Study Design

Patients with cardiogenic shock were randomized in a 1:1 double-blind fashion to receive milrinone (n = 96) or dobutamine (n = 96). A standardized dosing scale ranging from stage 1 (dobutamine 2.5 μg/kg/min or milrinone 0.125 μg/kg/min) to stage 5 (dobutamine >10.0 μg/kg/min or milrinone >0.5 μg/kg/min) was employed based on clinical judgment.

  • Total screened: 319
  • Total number of enrollees: 192
  • Duration of follow-up: Outcomes limited to the index hospitalization
  • Mean patient age: 71 years
  • Percentage female: 35%

Inclusion criteria:

  • Age >18 years
  • Admitted to intensive care unit (ICU)
  • Society for Cardiovascular Angiography and Interventions (SCAI) definition of cardiogenic shock stage B, C, D, or E

Exclusion criteria:

  • Presentation with out-of-hospital cardiac arrest
  • Initiation of milrinone or dobutamine prior to ICU transfer

Other salient features/characteristics:

  • White race: 86%
  • Median left ventricular ejection fraction (LVEF): 25%
  • Roughly two-thirds with ischemic cardiomyopathy as cause of LV dysfunction
  • Majority of patients had SCAI cardiogenic shock class C (~80%) or D (~11%), indicating “Classic” or “Deteriorating” cardiogenic shock

Principal Findings:

The primary outcome, a composite of in-hospital all-cause death, resuscitated cardiac arrest, receipt of cardiac transplant or mechanical circulatory support, nonfatal myocardial infarction, transient ischemic attack or stroke, or initiation of renal replacement therapy, for milrinone vs. dobutamine, was 49% vs. 54% (relative risk 0.90, 95% confidence interval 0.70-1.19, p = 0.47).

Secondary outcomes for milrinone vs. dobutamine (all not statistically significant):

  • All-cause in-hospital death: 37% vs. 43%
  • Receipt of cardiac transplant or mechanical circulatory support: 12% vs. 15%
  • Initiation of renal replacement therapy: 22% vs. 17%
  • Median cardiac ICU length of stay: 4.5 days vs. 5.5 days
  • Normalization of lactate level: 46% vs. 56%
  • Arrhythmia leading to medical team intervention: 50% vs. 46%

Interpretation:

The results of this trial indicate that among patients with cardiogenic shock, there were no differences in the composite primary outcome or secondary outcomes between milrinone or dobutamine. The incidence of in-hospital death was high in both groups, without any differences in other adverse clinical outcomes between the two groups.

Data to help guide treatment of patients with cardiogenic shock are limited, and the current study addresses an important knowledge gap. There does not appear to be a meaningful difference between inotropic therapy with milrinone or dobutamine with poor outcomes regardless of treatment type. However, the study was conducted in a single center, which may limit generalizability across other centers. Additionally, the trial was underpowered to detect smaller effects between milrinone and dobutamine given the expectation of a large treatment effect with milrinone as compared to dobutamine. Upcoming trials investigating the role of temporary mechanical circulatory support in cardiogenic shock may provide further data to help guide patients with cardiogenic shock.

References:

Mathew R, Di Santo P, Jung RG, et al. Milrinone as Compared With Dobutamine in the Treatment of Cardiogenic Shock. N Engl J Med 2021;385:516-25.

Clinical Topics: Arrhythmias and Clinical EP, Cardiac Surgery, Cardiovascular Care Team, Geriatric Cardiology, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Prevention, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Cardiac Surgery and Arrhythmias, Cardiac Surgery and Heart Failure, Acute Heart Failure, Heart Transplant, Interventions and Imaging, Angiography, Nuclear Imaging

Keywords: Arrhythmias, Cardiac, Cardiomyopathies, Coronary Angiography, Dobutamine, Geriatrics, Heart Arrest, Heart Failure, Heart Transplantation, Hospital Mortality, Intensive Care Units, Ischemic Attack, Transient, Lactates, Length of Stay, Milrinone, Myocardial Infarction, Myocardial Ischemia, Renal Replacement Therapy, Risk, Secondary Prevention, Shock, Cardiogenic, Stroke


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