Can Pro-Brain Natriuretic Peptide Guided Therapy of Heart Failure Improve Heart Failure Morbidity and Mortality? - PRIMA

Dec 06, 2010
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
The Netherlands Organization of Scientific Research
Date Presented:
01/01/2009
Date Published:
01/01/2010
Date Updated:
12/06/2010
Original Posted Date:
12/06/2010
References

Description:

The goal of the trial was to evaluate N-terminal portion of probrain natriuretic peptide (NT-proBNP) guided management compared with clinically guided management in patients with heart failure.

Hypothesis:

NT-proBNP guided management would be more effective in preventing complications of heart failure.

Study Design

  • Parallel
  • Randomized

Patients Enrolled: 345
Mean Follow Up: Median 702 days
Mean Patient Age: 71 years
Female: 45%
Mean Ejection Fraction: 31%

Patient Populations:

  • Patients admitted with decompensated heart failure with an elevated NT-proBNP level on admission that dropped at least 10% during hospitalization

Exclusions:

  • Significant cardiac arrhythmia
  • Urgent surgical intervention
  • Severe chronic obstructive pulmonary disease
  • Recent pulmonary embolism
  • Limited survival
  • Patients on hemodialysis

Primary Endpoints:

  • Number of days alive outside of the hospital

Secondary Endpoints:

  • Cardiovascular mortality
  • Heart failure, cardiovascular and total hospitalization
  • Death or hospitalization
  • Use of evidence-based heart failure medications
  • Analysis of patients who do not have a decrease in their NT-proBNP level

Drug/Procedures Used:

Patients admitted for worsening heart failure and whose NT-proBNP decreased during their admission were randomized at discharge to NT-proBNP guided management (n = 174) versus clinically guided management (n = 171).

Principal Findings:

Overall, 345 patients were randomized. The mean age was 71 years, 45% were women, 37% had a history of myocardial infarction, mean left ventricular ejection fraction was 31%, and median NT-proBNP level at admission was 8,034 pmol/L.

The occurrence of the primary outcome, number of days alive outside the hospital, was 685 with NT-proBNP guided management versus 664 with control (p = 0.49). Total mortality was 26.5% versus 33.3% (p = 0.21), respectively. There was no difference between the groups in any of the secondary outcomes.

Interpretation:

Among patients admitted with decompensated heart failure, NT-proBNP guided therapy did not reduce the number of days alive outside the hospital or total mortality. This study reveals that NT-proBNP guided management of heart failure patients may not be effective, although NT-proBNP levels portend important prognostic information.

References:

Eurlings LW, van Pol PE, Kok WE, et al. Management of Chronic Heart Failure Guided by Individual N-Terminal Pro–B-Type Natriuretic Peptide Targets: Results of the PRIMA (Can PRo-brain-natriuretic peptide guided therapy of chronic heart failure IMprove heart fAilure morbidity and mortality?) Study. J Am Coll Cardiol 2010;56:2090-2100. 

Can Pro-Brain Natriuretic Peptide Guided Therapy of Heart Failure Improve Heart Failure Morbidity and Mortality? Main Outcome of the PRIMA-Study. Presented by Dr. Luc Eurlings at ACC.09/i2, Orlando, FL, March 2009.

Keywords: Myocardial Infarction, Heart Failure, Peptide Fragments, Stroke Volume, Natriuretic Peptide, Brain


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