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Randomized Controlled Trial Multicenter Study
NT-proBNP (N-Terminal pro-B-Type Natriuretic Peptide)-Guided Therapy in Acute Decompensated Heart Failure: PRIMA II Randomized Controlled Trial (Can NT-ProBNP-Guided Therapy During Hospital Admission for Acute Decompensated Heart Failure Reduce Mortality and Readmissions?).
- Susan Stienen, Khibar Salah, Arno H Moons, Adrianus L Bakx, Petra van Pol, R A Mikael Kortz, João Pedro Ferreira, Irene Marques, Jutta M Schroeder-Tanka, Jan T Keijer, Antoni Bayés-Genis, Tijssen Jan G P JGP Department of Cardiology, Academic Medical Center, Amsterdam, The Netherlands (S.S., K.S., J.G.P.T., Y.M.P., W.E.K.)., Yigal M Pinto, and Wouter E Kok.
- Department of Cardiology, Academic Medical Center, Amsterdam, The Netherlands (S.S., K.S., J.G.P.T., Y.M.P., W.E.K.).
- Circulation. 2018 Apr 17; 137 (16): 1671-1683.
BackgroundThe concept of natriuretic peptide guidance has been extensively studied in patients with chronic heart failure (HF), with only limited success. The effect of NT-proBNP (N-terminal probrain natriuretic peptide)-guided therapy in patients with acute decompensated HF using a relative NT-proBNP target has not been investigated. This study aimed to assess whether NT-proBNP-guided therapy of patients with acute decompensated HF using a relative NT-proBNP target would lead to improved outcomes compared with conventional therapy.MethodsWe conducted a prospective randomized controlled trial to study the impact of in-hospital guidance for acute decompensated HF treatment by a predefined NT-proBNP target (>30% reduction from admission to discharge) versus conventional treatment. Patients with acute decompensated HF with NT-proBNP levels >1700 ng/L were eligible. After achieving clinical stability, 405 patients were randomized to either NT-proBNP-guided or conventional treatment (1:1). The primary end point was dual: a composite of all-cause mortality and HF readmissions in 180 days and the number of days alive out of the hospital in 180 days. Secondary end points were all-cause mortality within 180 days, HF readmissions within 180 days, and a composite of all-cause mortality and HF readmissions within 90 days.ResultsSignificantly more patients in the NT-proBNP-guided therapy group were discharged with an NT-proBNP reduction of >30% (80% versus 64%, P=0.001). Nonetheless, NT-proBNP-guided therapy did not significantly improve the combined event rate for all-cause mortality and HF readmissions (hazard ratio, 0.96; 95% confidence interval, 0.72-1.37; P=0.99) or the median number of days alive outside of the hospital (178 versus 179 days for NT-proBNP versus conventional patients, P=0.39). Guided therapy also did not significantly improve any of the secondary end points.ConclusionsThe PRIMA II trial (Can NT-ProBNP-Guided Therapy During Hospital Admission for Acute Decompensated Heart Failure Reduce Mortality and Readmissions?) demonstrates that the guidance of HF therapy to reach an NT-proBNP reduction of >30% after clinical stabilization did not improve 6-month outcomes.Clinical Trial RegistrationURL: http://www.trialregister.nl. Unique identifier: NTR3279.© 2017 American Heart Association, Inc.
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