Martin Möckel1, Rudolf A de Boer2, Anna Christine Slagman1, Stephan von Haehling3, Morten Schou4, Jörn Ole Vollert5, Jan C Wiemer5, Stefan Ebmeyer5, F Javier Martín-Sánchez6, Alan S Maisel7, Evangelos Giannitsis8. 1. Department of Cardiology, Division of Emergency and Acute Medicine Campus Charité Mitte and Virchow-Klinikum, Charité - Universitätsmedizin Berlin, Berlin, Germany. 2. Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands. 3. Department of Cardiology and Pneumology, University of Goettingen Medical Center, Goettingen, Germany and German Center for Cardiovascular Research (DZHK), partner site Goettingen, Germany. 4. Department of Cardiology, Herlev and Gentofte Hospital, University of Copenhagen, Herlev, Denmark. 5. Clinical Diagnostics, Thermo Fisher Scientific, Hennigsdorf, Germany. 6. Emergency Department, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria Hospital Clínico San Carlos (IdISSC), Universidad Complutense de Madrid, Madrid, Spain. 7. University of California, San Diego, CA, USA. 8. Abteilung Innere Medizin III Kardiologie, Angiologie und Pneumologie, Medizinische Universitätsklinik Heidelberg, Heidelberg, Germany.
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.
RCT Entities:
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.
Authors: Wouter C Meijers; Antoni Bayes-Genis; Alexandre Mebazaa; Johann Bauersachs; John G F Cleland; Andrew J S Coats; James L Januzzi; Alan S Maisel; Kenneth McDonald; Thomas Mueller; A Mark Richards; Petar Seferovic; Christian Mueller; Rudolf A de Boer Journal: Eur J Heart Fail Date: 2021-10-10 Impact factor: 17.349
Authors: Fabrice F Darche; Moritz Biener; Matthias Müller-Hennessen; Rasmus Rivinius; Kiril M Stoyanov; Barbara R Milles; Hugo A Katus; Norbert Frey; Evangelos Giannitsis Journal: Life (Basel) Date: 2021-12-18