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NT-proBNP-Guided Therapy in Acute Decompensated Heart Failure: The PRIMA II Randomized Controlled Trial.
Circulation. 2017 Dec 14;:
Authors: Stienen S, Salah K, Moons AH, Bakx AL, van Pol P, Kortz M, Ferreira JP, Marques I, Schroeder-Tanka JM, Keijer JT, Bayés-Genis A, Tijssen JGP, Pinto YM, Kok WE
Abstract
Background -The concept of natriuretic peptide guidance has been extensively studied in chronic heart failure (HF) patients, with only limited success. The effect of NT-proBNP-guided therapy in acute decompensated HF (ADHF) patients using a relative NT-proBNP target has not been investigated. The aim of this study was to assess whether NT-proBNP-guided therapy of ADHF patients using a relative NT-proBNP target would lead to improved outcome compared with conventional therapy. Methods -We conducted a prospective randomized, controlled trial to study the impact of in-hospital guidance for ADHF treatment by a predefined NT-proBNP target (>30% reduction from admission to discharge) versus conventional treatment. ADHF patients with NT-proBNP levels of > 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 endpoint was dual, i.e. 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 endpoints 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. Results -Significantly 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 (HR for NT-proBNP-guided therapy, 0.96; 95% CI, 0.72 to 1.37; P=0.99), or the median number of days alive outside of the hospital (178 vs. 179 days for NT-proBNP vs. conventional patients, P=0.39). Guided therapy also did not significantly improve any of the secondary endpoints. Conclusions -The PRIMA II demonstrates that that guidance of HF therapy to reach an NT-proBNP reduction of >30% after clinical stabilization did not improve 6-months outcome. Clinical Trial Registration -URL: http://www.trialregister.nl Unique Identifier: NTR3279.
PMID: 29242350 [PubMed - as supplied by publisher]