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Improve Management of acute heart failure with ProcAlCiTonin in EUrope: results of the randomized clinical trial IMPACT EU Biomarkers in Cardiology (BIC) 18.
European Journal of Heart Failure ( IF 18.2 ) Pub Date : 2019-12-12 , DOI: 10.1002/ejhf.1667
Martin Möckel 1 , Rudolf A de Boer 2 , Anna Christine Slagman 1 , Stephan von Haehling 3 , Morten Schou 4 , Jörn Ole Vollert 5 , Jan C Wiemer 5 , Stefan Ebmeyer 5 , F Javier Martín-Sánchez 6 , Alan S Maisel 7 , Evangelos Giannitsis 8
Affiliation  

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.

中文翻译:

在EUrope中使用ProcAlCiTonin改善急性心力衰竭的管理:随机临床试验IMPACT EU心脏生物学生物标志物(BIC)的结果18。

目的确定在急诊就诊并出现急性心力衰竭(AHF)症状和体征的钠尿利尿肽水平升高的患者,在入院后8小时内通过降钙素原(PCT)进行抗生素治疗(ABX)是否会改善临床疗效。方法和结果该研究是一项在欧洲16个地点进行的随机多中心临床试验。患者被随机分为PCT指导策略或标准治疗。如果PCT> 0.2μg/ L,则采用PCT指导策略的患者(n = 370)开始进行ABX。具有标准护理的患者(n = 372)根据已发布的指南进行了AHF护理,而没有PCT。主要终点是90天全因死亡率。预先指定的次要终点包括30天全因死亡率,再入院率和肺炎发生率。数据安全和审查委员会建议,在计划的792名患者中有762名患者入组后,停止研究无济于事。总共可以分析742名患者。患者为老年人(中位年龄为77岁),女性为38%,具有典型的AHF症状和体征。PCT指导组在90天时的全因死亡率为10.3%,而标准护理为8.2%(P = 0.316)。PCT指导组的30天再入院率明显高于标准护理,但这种差异一直持续到第90天为止。肺炎的发生率总体较低(7.5%),各组之间无差异。结论在AHF患者中,以PCT指导的ABX起始策略在改善临床结局方面并不比标准的护理策略更有效。总共可以分析742名患者。患者为老年人(中位年龄为77岁),女性为38%,具有典型的AHF症状和体征。PCT指导组在90天时的全因死亡率为10.3%,而标准护理为8.2%(P = 0.316)。PCT指导组的30天再入院率明显高于标准护理,但这种差异一直持续到第90天为止。肺炎的发生率总体较低(7.5%),各组之间无差异。结论在AHF患者中,以PCT指导的ABX起始策略在改善临床结局方面并不比标准的护理策略更有效。总共可以分析742名患者。患者为老年人(中位年龄为77岁),女性为38%,具有典型的AHF症状和体征。PCT指导组在90天时的全因死亡率为10.3%,而标准护理为8.2%(P = 0.316)。PCT指导组的30天再入院率明显高于标准护理,但这种差异一直持续到第90天为止。肺炎的发生率总体较低(7.5%),各组之间无差异。结论在AHF患者中,以PCT指导的ABX起始策略在改善临床结局方面并不比标准的护理策略更有效。在标准护理中为2%(P = 0.316)。PCT指导组的30天再入院率明显高于标准护理,但这种差异一直持续到第90天为止。肺炎的发生率总体较低(7.5%),各组之间无差异。结论在AHF患者中,以PCT指导的ABX起始策略在改善临床结局方面并不比标准的护理策略更有效。在标准护理中为2%(P = 0.316)。PCT指导组的30天再入院率明显高于标准护理,但这种差异一直持续到第90天为止。肺炎的发生率总体较低(7.5%),各组之间无差异。结论在AHF患者中,以PCT指导的ABX起始策略在改善临床结局方面并不比标准的护理策略更有效。
更新日期:2019-12-13
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