Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness (ESCAPE): Design and rationale

Background There is little information about how to adjust pharmacologic ag ents in the treatment of patients with advanced congestive heart failure (C HF). Some studies have suggested that use of pulmonary artery catheterizati on to guide reductions in filling pressures may improve outcomes for patien ts with heart failure who are hospitalized with evidence of elevated fillin g pressures. However, there is no consensus regarding the true utility of t his strategy. A randomized clinical trial is needed to test the safety, eff icacy, and treatment benefit of pulmonary artery catheterization in patient s with advanced CHF. Study Design The Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness (ESCAPE) trial is a multicenter, rand omized trial designed to test the long-term safety and efficacy of treatmen t guided by hemodynamic monitoring and clinical assessment versus that guid ed by clinical assessment alone in patients hospitalized with New York Hear t Association class IV CHF. Five hundred patients will be randomly assigned to receive either medical therapy guided by a combination of clinical asse ssment and hemodynamic monitoring (PAC arm) or medical therapy guided by cl inical assessment alone (CLIN arm). The primary end point of ESCAPE will be the number of days that patients are hospitalized or die during the 6-mont h period after randomization. Secondary end points will include changes in mitral regurgitation, peak oxygen consumption, and natriuretic peptide leve ls. Other secondary end points will be pulmonary artery catheter-associated complications, resource utilization, quality of life measures, and patient preferences regarding survival. Implications The primary goal of ESCAPE will be to provide information abou t the utility of the pulmonary artery catheter in patients with advanced he art failure, independent of various treatment approaches used by individual physicians. In addition, this study will define current outcomes for this severely compromised population.