Improve Management of acute heart failure with ProcAlCiTonin in EUrope: results of the randomized clinical trial IMPACT EU Biomarkers in Cardiology (BIC) 18

Martin Möckel*, Rudolf A. de Boer, Anna Christine Slagman, Stephan von Haehling, Morten Schou, Jörn Ole Vollert, Jan C. Wiemer, Stefan Ebmeyer, F. Javier Martín-Sánchez, Alan S. Maisel, Evangelos Giannitsis

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

20 Citations (Scopus)

Abstract

Aim: To determine whether initiation of antibiotic therapy (ABX) by procalcitonin (PCT) within 8 h of admission in patients presenting to the emergency department with symptoms and signs of acute heart failure (AHF) and elevated natriuretic peptides would improve clinical outcomes. Methods and results: The study was a randomized multicentre clinical trial conducted at 16 sites in Europe. Patients were randomized to either a PCT-guided strategy or standard care. Patients with PCT-guided strategy (n = 370) had ABX initiated if PCT was > 0.2 μg/L. Patients with standard care (n = 372) had AHF care in accordance with published guidelines without PCT. The primary endpoint was 90-day all-cause mortality. Pre-specified secondary endpoints included 30-day all-cause mortality and readmission and rate of pneumonia. The Data Safety and Review Committee recommended stopping the study for futility when 762 of the planned 792 patients had been enrolled. A total of 742 patients could be analysed. Patients were elderly (median age: 77 years), 38% were women, and had typical signs and symptoms of AHF. All-cause mortality at 90 days was 10.3% in the PCT-guided group vs. 8.2% in standard care (P = 0.316). Thirty-day readmission was significantly higher in the PCT-guided group vs. standard care but the difference vanished until day 90. The rate of pneumonia was overall low (7.5%) and not different between groups. Conclusions: In patients with AHF, a strategy of PCT-guided initiation of ABX was not more effective than a standard care strategy in improving clinical outcomes.

Original languageEnglish
Pages (from-to)267-275
Number of pages9
JournalEuropean Journal of Heart Failure
Volume22
Issue number2
DOIs
Publication statusPublished - 1 Feb 2020
Externally publishedYes

Bibliographical note

Funding Information:
M.M. received honoraria for lectures from Roche Diagnostics, AstraZeneca, Bayer Vital, Daiichi‐Sankyo, Boehringer Ingelheim and BRAHMS Thermo Fisher Scientific; serves as a consultant for BRAHMS Thermo Fisher Scientific and Bayer, and has received research funding from BRAHMS Thermo Fisher Scientific, Roche Diagnostics, and Radiometer. R.A.d.B.: the UMCG, which employs Dr. de Boer, has received research grants and/or fees from AstraZeneca, Abbott, Bristol‐Myers Squibb, Novartis, Novo Nordisk, Roche and BRAHMS Thermo Fisher Scientific R.A.d.B. is a minority shareholder of scPharmaceuticals Inc. and received personal fees from Abbott, AstraZeneca, MandalMed Inc., Novartis and BRAHMS Thermo Fisher Scientific. A.C.S. received research support from Roche Molecular Diagnostics. J.O.V., J.C.W. and S.E. are employees of BRAHMS Thermo Fisher Scientific. S.v.H. has received consulting honoraria from Roche and BRAHMS Thermo Fisher Scientific. E.G. received honoraria for lectures from Roche Diagnostics, AstraZeneca, Bayer, Daiichi‐Sankyo, Lilly Eli Deutschland; serves as a consultant for Roche Diagnostics, BRAHMS Thermo Fisher Scientific, Boehringer Ingelheim; and has received research funding from BRAHMS Thermo Fisher Scientific, Roche Diagnostics, Bayer Vital and Daiichi Sankyo. The other authors declare no conflicts of interest. Conflict of interest:

Funding Information:
We thank the collaborators Matthias Müller-Hennessen, Christoph Liebetrau, Christoph Kadel, Till Keller, Caroline Kistorp, Søren Vraa, Jacob Møller, Hans-Peter Brunner-LaRocca, Nick Marcks, Michael Christ, Tobias Graf, Volker Burst and their study teams in the centres who made this challenging study possible, and all patients who gave informed consent and contributed to the development of diagnosis and treatment of acute heart failure. Conflict of interest: M.M. received honoraria for lectures from Roche Diagnostics, AstraZeneca, Bayer Vital, Daiichi-Sankyo, Boehringer Ingelheim and BRAHMS Thermo Fisher Scientific; serves as a consultant for BRAHMS Thermo Fisher Scientific and Bayer, and has received research funding from BRAHMS Thermo Fisher Scientific, Roche Diagnostics, and Radiometer. R.A.d.B.: the UMCG, which employs Dr. de Boer, has received research grants and/or fees from AstraZeneca, Abbott, Bristol-Myers Squibb, Novartis, Novo Nordisk, Roche and BRAHMS Thermo Fisher Scientific R.A.d.B. is a minority shareholder of scPharmaceuticals Inc. and received personal fees from Abbott, AstraZeneca, MandalMed Inc., Novartis and BRAHMS Thermo Fisher Scientific. A.C.S. received research support from Roche Molecular Diagnostics. J.O.V., J.C.W. and S.E. are employees of BRAHMS Thermo Fisher Scientific. S.v.H. has received consulting honoraria from Roche and BRAHMS Thermo Fisher Scientific. E.G. received honoraria for lectures from Roche Diagnostics, AstraZeneca, Bayer, Daiichi-Sankyo, Lilly Eli Deutschland; serves as a consultant for Roche Diagnostics, BRAHMS Thermo Fisher Scientific, Boehringer Ingelheim; and has received research funding from BRAHMS Thermo Fisher Scientific, Roche Diagnostics, Bayer Vital and Daiichi Sankyo. The other authors declare no conflicts of interest.

Publisher Copyright:
© 2019 The Authors.European Journal of Heart Failure © 2019 European Society of Cardiology

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