The PROACTION trial is the first multicenter prospective trial to evaluate OU outcomes.
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The PROACTION study, or Prospective Randomized Outcomes study of Acutely decompensated CHF Treated Initially as Outpatients with Nesiritide, was a study run in the ED/Observation Unit to look at the safety and efficacy of using nesiritide to treat acute heart failure in the ED/Obs Unit setting.
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PROACTION was a multicenter, double-blind, randomized, placebo-controlled study of patients who had acutely decompensated heart failure with dyspnea at rest or with minimal activity. Patients were randomized to standard care plus either nesiritide or placebo for a minimum of 12 hours. At the 24-hour point patients were either discharged or admitted to the hospital.
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There were 237 patients total, with 120 randomized to the nesiritide group and 117 to placebo.
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We saw a very small incidence of symptomatic hypotension in the study. All episodes were rated as mild-to-moderate and transient, as all we had to do was turn off the drug and the patient returned to normal.
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There were no differences in mortality at 7 and 30 days, with an overall rate of 2.5%. None of the deaths were attributed to the study drug.
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The outcomes of the study for nesiritide patients included an 11% reduction in 30-day readmissions, a 21% reduction in heart failure readmissions, and a 29% reduction in readmissions for Class III and IV heart failure patients. The P-value for these results does not quite reach statistical significance because of the small patient numbers, but it suggests that the sicker patients are, the greater the benefit they are likely to receive from nesiritide.
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When we look at patients who were admitted to the hospital rather than discharged home at the 24-hour point, we see a 57% decrease in 30-day rehospitalizations. In addition, if patients are rehospitalized, their LOS is 45% shorter with nesiritide. The cost analysis done with the study revealed no difference in cost between nesiritide and standard therapy.
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If you look at total days in hospital over 30 days, the median is 2.5 days for the nesiritide group vs 6.5 days for standard therapy alone (p=0.032). This represents a marked decrease in the amount of unreimbursed care a hospital must provide.
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One very interesting pattern we found in PROACTION was the effect of nesiritide on blood pressure. We saw that patients who were borderline hypotensive, or those with SBPs of 100 or below, had only a relatively minimal drop in BP with nesiritide of 1.24%. However, if their baseline SBP was elevated to 140 or above, they had a relatively beneficial drop in BP of 18%. By contrast, with standard care, patients with elevated SBPs had a much less robust drop of 5.3%. This suggests that nesiritide will not worsen baseline low SBP, which means that you really don't have to worry about hypotension with this drug.
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So the PROACTION study has demonstrated that nesiritide can be used without hemodynamic monitoring in an OU environment and provide improved outcomes in a cost-effective manner, as compared to an already-validated standard therapy model.
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Welcome to our program on Acute Heart Failure: The Emergency Department and the Economics of Care. This is a CME-accredited program that focuses on optimizing treatment strategies in the Emergency Department in order to improve outcomes and reduce overall costs to the hospital.
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When you think about the overall hospital costs of a 5-day admission for an acute condition that often requires ICU care and invasive procedures, you don't necessarily think about the Emergency Department. After all, the patient is usually only in the ED for a few short hours, compared to the several days they will spend as an inpatient. But when it comes to treating acute heart failure, we are beginning to learn that what occurs during those critical initial hours in the Emergency Department has a direct and significant impact on overall treatment outcomes, including the length of stay as an inpatient, the utilization of expensive resources, and the likelihood of readmission to the hospital within the near term.
