ESCAPE (heart failure)
Trial question
What is the role of pulmonary artery catheter in patients hospitalized with severe symptomatic and recurrent HF?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
26.0% female
74.0% male
N = 433
433 patients (113 female, 320 male).
Inclusion criteria: patients hospitalized with severe symptomatic and recurrent HF.
Key exclusion criteria: creatinine level > 3.5 mg/dL, or prior use of dobutamine or dopamine > 3 mcg/kg/min, or any prior use of milrinone during the current hospitalization.
Interventions
N=215 pulmonary artery catheter-guided resuscitation (therapy guided by clinical assessment and pulmonary artery catheters).
N=218 resuscitation based on clinical assessment (therapy guided by clinical assessment alone).
Primary outcome
Time alive out of hospital at 6 months
133 days
135 days
135.0 days
101.3 days
67.5 days
33.8 days
0.0 days
Pulmonary artery catheter-guided
resuscitation
Resuscitation based on clinical
assessment
No significant
difference ↔
No significant difference in time alive out of hospital at 6 months (133 days vs. 135 days; HR 1, 95% CI 0.82 to 1.21).
Secondary outcomes
No significant difference in death (10% vs. 9%; OR 1.26, 95% CI 0.78 to 2.03).
No significant difference in the number of days hospitalized (8.7 vs. 8.3; HR 1.04, 95% CI 0.86 to 1.27).
No significant difference in in-hospital death or death at 30 days (4.7% vs. 5%; OR 0.97, 95% CI 0.38 to 2.22).
Safety outcomes
Significant differences in in-hospital adverse events (21.9% vs. 11.5%, p = 0.04).
Conclusion
In patients hospitalized with severe symptomatic and recurrent HF, pulmonary artery catheter-guided resuscitation was not superior to resuscitation based on clinical assessment with respect to time alive out of hospital at 6 months.
Reference
Binanay C, Califf RM, Hasselblad V et al. Evaluation study of congestive heart failure and pulmonary artery catheterization effectiveness: the ESCAPE trial. JAMA. 2005 Oct 5;294(13):1625-33.
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