Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness - ESCAPE
The goal of the trial was to evaluate whether use of a pulmonary artery catheter (PAC) to guide therapy was associated with improvements in clinical outcomes compared with clinical assessment alone in patients hospitalized with recurrent heart failure, but without an established need for a PAC.
For patients with severe heart failure, therapy guided by clinical assessment plus PAC would lead to fewer days neither dead nor hospitalized compared with therapy guided by clinical assessment alone.
Patients Enrolled: 433
Mean Follow Up: Six months
Mean Patient Age: Mean age 56 years
Mean Ejection Fraction: Baseline ejection fraction 20%
Decompensated heart failure, history of advanced heart failure despite treatment with standard therapy, left ventricular ejection fraction <30%, systolic blood pressure ≤125 mm Hg, and symptoms of heart failure for ≥ 3 months
Acute decompensated heart failure requiring PAC or serum creatinine >3.5 mg/dl
Days neither dead nor hospitalized through six months
Time to death or rehospitalization, exercise, quality of life, and echocardiographic changes
Patients were randomized to either therapy guided by clinical assessment alone (n=218) or clinical assessment plus PAC (n=215). Target in both arms was resolution of clinical congestion. PAC targets also included pulmonary capillary wedge pressure ≤15 and right atrial pressure ≤8 mm Hg. Inotrope use was discouraged.
Diuretic (98%), angiotensin-converting enzyme inhibitor or ARBs (90%), and beta-blocker (62%)
The study population had severe illness, as demonstrated by a mean left ventricular ejection fraction of 20% and mean systolic blood pressure of 106 mm Hg. Heart failure type was ischemic in 50% of patients. PAC was used in 92% of patients randomized to the PAC group and 10% of the clinical assessment group.
The trial was discontinued early by the Data Safety Monitoring Board due to lack of efficacy. There was no difference between groups in the primary endpoint of days neither dead nor hospitalized through six months (133 days vs 135 days, hazard ratio 1.00; 95% confidence interval 0.82-1.21, p=0.99). There was also no difference in the frequency of rehospitalization (mean 2.0 per patient in each group) or death (10% for PAC vs. 9% for clinical assessment alone). Both groups had improvements in exercise and quality of life endpoints, with a nonsignificant trend for a larger improvement in the PAC group.
PAC-related complications occurred in 4.2% of patients in the PAC group and 0.5% of patients in the clinical assessment group. Frequency of adverse events was 22% of patients in the PAC group versus 11% in the clinical assessment group.
Among patients hospitalized with recurrent heart failure, but without an established need for a PAC, use of PAC to guide therapy was not associated with a reduction in days neither dead nor hospitalized compared with clinical assessment alone.
Early nonrandomized studies of PAC guided therapy in critically ill patients raised the question of not only whether use of PAC was beneficial, but also whether use of PAC may increase morbidity and mortality. The present study demonstrates that while there was no increase in death or hospitalization associated with PAC use, there was also no benefit associated with PAC use in patients with severe heart failure.
The cost analysis component of the study is not yet available. Additionally, it should be noted that the patients studied in the present trial had severe heart failure, but did not have an indication for PAC guided therapy, and these data cannot be extrapolated to patients that do have an indication for PAC guided therapy.
The ESCAPE Investigators. Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness: The ESCAPE Trial. JAMA 2005;294 1625-1633.
Presented by Monica R. Shah at the American Heart Association Scientific Sessions, November 2004, New Orleans, LA.
Keywords: Pulmonary Wedge Pressure, Human Rights, Clinical Trials Data Monitoring Committees, Blood Pressure, Pulmonary Artery, Catheterization, Swan-Ganz, Systole, Atrial Pressure, Quality of Life, Heart Failure, Critical Illness, Stroke Volume, Confidence Intervals
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