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

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.

The year in cardiovascular medicine 2020: heart failure and cardiomyopathies

“…U novim multicentričnim istraživanjima otvorenog dizajna, strategija PCT-om vođenim započinjanjem antibiotske terapije bila je efikasnija od standardne skrbi u poboljšanju kliničkih ishoda. 33 Omics fenotipizacija vjerojatna je sljedeća granica prema razumijevanju mehanizma bolesti i heterogenosti. 34 U nedavnom primjeru uključivanjem panela od triju biomarkera metabolita u procjenu rizika poboljšala se prognostička korist od NT-proBNP-a pri predviđanju dugoročne CV smrtnosti.…”

February 2020 at a glance: acute heart failure and cardio‐oncology

“…Möckel et al 5 conducted a randomized multicentre clinical trial assessing the role of serum procalcitonin (PCT) measurements in 742 patients admitted for AHF. The strategy of PCT-guided initiation of antibiotic therapy was not more effective than the standard care strategy in improving clinical outcomes.…”

“…Möckel et al . conducted a randomized multicentre clinical trial assessing the role of serum procalcitonin (PCT) measurements in 742 patients admitted for AHF.…”

Biomarker‐guided management in acute heart failure: is there light at the end of the tunnel?

“…In patients with acute dyspnoea, plasma PCT has been used to differentiate between AHF and superimposed pneumonia and been postulated as a promising biomarker for guiding antibiotic therapy in patients with AHF. 9 In the current issue of the Journal, Möckel et al 10 provide the results of a randomized multicentre clinical trial, Improve Management of Acute Heart Failure with Procalcitonin in Europe (IMPACT EU). This study, which was terminated prematurely due to futility, aimed to evaluate whether PCT-guided initiation of antibiotics in patients with suspicion of AHF who present to the emergency department would improve clinical outcomes.…”

“…In the current issue of the Journal, Möckel et al . provide the results of a randomized multicentre clinical trial, Improve Management of Acute Heart Failure with Procalcitonin in Europe (IMPACT EU).…”