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No sex-based difference in cardiogenic shock: A post-hoc analysis of the DOREMI trial
Graeme Prosperi-Porta1, Pouya Motazedian1, Pietro Di Santo2
1CAPITAL Research Group, Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada; Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.
Insights
This study found no significant differences in clinical outcomes for male and female patients experiencing cardiogenic shock (CS) when treated with dobutamine or milrinone. Further research is needed to understand sex-based disparities in CS treatment.
Area of Science:
- Cardiology
- Clinical Trials
- Sex Differences in Medicine
Background:
- Cardiogenic shock (CS) carries high morbidity and mortality.
- Limited randomized data exist on sex-based differences in CS outcomes.
- The DOREMI trial investigated dobutamine versus milrinone for CS.
Purpose of the Study:
- To evaluate the association between sex and clinical outcomes in patients with cardiogenic shock.
- To analyze outcomes based on sex in the DOREMI trial cohort.
Main Methods:
- Post-hoc analysis of the DOREMI trial data.
- Inclusion of 192 patients (70 female, 122 male) with CS.
- Primary outcome: composite of mortality, cardiac arrest, transplant/MCS, MI, stroke, or RRT.
- Secondary outcomes: individual components of the primary outcome.
- Adjusted analyses for primary outcome and all-cause mortality.
Main Results:
- No significant difference in the primary composite outcome between females and males (aRR 1.23; P=0.97).
- No sex-based differences in outcomes were observed when stratified by inotrope (dobutamine or milrinone).
- All-cause mortality and secondary outcomes showed no significant differences between sexes.
Conclusions:
- In CS patients treated with milrinone or dobutamine, clinical outcomes did not differ between males and females.
- The study suggests no immediate sex-based disparity in outcomes for these specific treatments in CS.
Background:
Cardiogenic shock (CS) is associated with significant morbidity and mortality; however, there are limited randomized data evaluating the association between sex and clinical outcomes in patients with CS. Patients with CS enrolled in the DObutamine compaREd with MIlrinone (DOREMI) trial were evaluated in this post-hoc analysis.
Methods:
The primary outcome was a composite of all-cause mortality, resuscitated cardiac arrest, cardiac transplant or mechanical circulatory support, non-fatal myocardial infarction, transient ischemic attack or stroke, or initiation of renal replacement therapy. Secondary outcomes included the individual components of the primary outcome. We analyzed the primary and secondary outcomes using unadjusted relative risks and performed adjusted analysis for the primary outcome and all-cause mortality using the covariates mean arterial pressure <70 mmHg at inotrope initiation, age, and acute myocardial infarction CS.
Results:
Among 192 participants in the DOREMI study, 70 patients (36 %) were female. The primary outcome occurred in 38 female patients (54 %) compared to 61 male patients (50 %) [adjusted relative risk (aRR) 1.23; 95 % CI 0.78-1.95, p = 0.97]. When stratified by inotrope, there was no difference in the primary outcome comparing females to males receiving dobutamine (RR 1.14; 95 % CI 0.79-1.65, p = 0.50) nor milrinone (RR 1.03; 95 % CI 0.68-1.57, p = 0.87). There was no difference in all-cause mortality comparing females to males (aRR 1.51; 95 % CI 0.78-2.94, p = 0.88). Additionally, there were no differences in any secondary outcomes between males and females (p > 0.05 for all endpoints).
Conclusion:
In patients presenting with CS treated with milrinone or dobutamine, no differences in clinical outcomes were observed between males and females.
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