Susan Stienen1, Khibar Salah1, Arno H Moons2, Adrianus L Bakx3, Petra van Pol4, R A Mikael Kortz5, João Pedro Ferreira6,7, Irene Marques8, Jutta M Schroeder-Tanka9, Jan T Keijer10, Antoni Bayés-Genis11, Jan G P Tijssen1, Yigal M Pinto1, Wouter E Kok12. 1. Department of Cardiology, Academic Medical Center, Amsterdam, The Netherlands (S.S., K.S., J.G.P.T., Y.M.P., W.E.K.). 2. Department of Cardiology, Slotervaartziekenhuis, Amsterdam, The Netherlands (A.H.M.). 3. Department of Cardiology, BovenIJ Ziekenhuis, Amsterdam, The Netherlands (A.L.B.). 4. Department of Cardiology, Alrijne Ziekenhuis, Leiderdorp, The Netherlands (P.v.P.). 5. Department of Cardiology, Flevoziekenhuis, Almere, The Netherlands (R.A.M.K.). 6. Department of Physiology and Cardiothoracic Surgery, Cardiovascular Research and Development Unit, Faculty of Medicine, University of Porto, Portugal (J.P.F.). 7. INSERM, Centre d'Investigations Cliniques Plurithématique, Université de Lorraine, CHRU de Nancy, France (J.P.F.). 8. Department of Internal Medicine, Centro Hospitalar do Porto, Instituto de Ciências Biomédicas de Abel Salazar, University of Porto, Portugal (I.M.). 9. Department of Cardiology, St Lucas Andreas Ziekenhuis, Amsterdam, The Netherlands (J.M.S.-T.). 10. Department of Cardiology, Tergooiziekenhuizen, Blaricum, The Netherlands (J.T.K.). 11. Department of Cardiology, Hospital Universitari Germans Trias i Pujol, Barcelona, Spain (A.B.-G.). 12. Department of Cardiology, Academic Medical Center, Amsterdam, The Netherlands (S.S., K.S., J.G.P.T., Y.M.P., W.E.K.). w.e.kok@amc.uva.nl.
Abstract
BACKGROUND: The 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. METHODS: We 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. 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 (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. CONCLUSIONS: The 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 REGISTRATION: URL: http://www.trialregister.nl. Unique identifier: NTR3279.
RCT Entities:
BACKGROUND: The 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. METHODS: We 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. 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 (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. CONCLUSIONS: The 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 REGISTRATION: URL: http://www.trialregister.nl. Unique identifier: NTR3279.
Authors: Catherine N Marti; Gregg C Fonarow; Stefan D Anker; Clyde Yancy; Muthiah Vaduganathan; Stephen J Greene; Ali Ahmed; James L Januzzi; Mihai Gheorghiade; Gerasimos Filippatos; Javed Butler Journal: Eur J Heart Fail Date: 2018-12-10 Impact factor: 15.534
Authors: Eva M Boorsma; Jozine M Ter Maaten; Kevin Damman; Wilfried Dinh; Finn Gustafsson; Steven Goldsmith; Daniel Burkhoff; Faiez Zannad; James E Udelson; Adriaan A Voors Journal: Nat Rev Cardiol Date: 2020-05-15 Impact factor: 32.419
Authors: David Paniagua; Glenn N Levine; Lorraine D Cornwell; Ernesto Jimenez; Biswajit Kar; Hani Jneid; Ali E Denktas; Tony S Ma Journal: Tex Heart Inst J Date: 2022-07-01
Authors: A Faragli; D Abawi; C Quinn; M Cvetkovic; T Schlabs; E Tahirovic; H-D Düngen; B Pieske; S Kelle; F Edelmann; Alessio Alogna Journal: Heart Fail Rev Date: 2021-09 Impact factor: 4.214