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心力衰竭患者口服抗凝药物的管理——来自 ThrombEVAL 研究的见解。

Management of Oral Anti-Coagulation in Patients with Heart Failure-Insights from the ThrombEVAL Study.

机构信息

German Center for Cardiovascular Research (DZHK), Partner Site RheinMain, Mainz, Germany.

Center for Cardiology - Cardiology I, University Medical Center of the Johannes Gutenberg, University Mainz, Mainz, Germany.

出版信息

Thromb Haemost. 2018 Nov;118(11):1930-1939. doi: 10.1055/s-0038-1673380. Epub 2018 Oct 24.

DOI:10.1055/s-0038-1673380
PMID:30357779
Abstract

Patients with heart failure (HF) are frequently anti-coagulated with vitamin K-antagonists (VKAs). The use of long-acting VKA may be preferable for HF patients due to higher stability of plasma concentrations. However, evidence on phenprocoumon-based oral anti-coagulation (OAC) therapy in HF is scarce. The aim of this study was to assess the impact of the presence of HF on quality of phenprocoumon-based OAC and the subsequent clinical outcome. Quality of OAC therapy and the incidence of adverse events were analysed in a cohort of regular care ( = 2,011) from the multi-centre thrombEVAL study program (NCT01809015) stratified by the presence of HF. To assess the modifiability of outcome, results were compared with data from individuals receiving specialized care for anti-coagulation ( = 760). Overall, the sample comprised of 813 individuals with HF and 1,160 subjects without HF in the regular care cohort. Quality of OAC assessed by time in therapeutic range (TTR) was 66.1% (47.8%/82.8%) for patients with HF and 70.6% (52.1%/85.9%) for those without HF ( = 0.0046). Stratification for New York Heart Classification (NYHA)-class demonstrated a lower TTR with higher NYHA classes: TTR 69.6% (49.4%/85.6%), TTR 66.5% (50.1%/82.9%) and TTR 61.8% (43.1%/79.9%). This translated into a worse net clinical benefit outcome for HF (hazard ratio [HR] 1.63 [1.31/2.02];  < 0.0001) and an increased risk of bleeding (HR 1.40 [1.04/1.89];  = 0.028). Management in a specialized coagulation service resulted in an improvement of all, TTR (∆+12.5% points), anti-coagulation-specific and non-specific outcome of HF individuals. In conclusion, HF is an independent risk factor for low quality of OAC therapy translating into an increased risk for adverse events, which can be mitigated by specialized care.

摘要

患有心力衰竭(HF)的患者通常会接受维生素 K 拮抗剂(VKAs)的抗凝治疗。由于血浆浓度稳定性较高,长效 VKA 可能更适合 HF 患者。然而,HF 患者基于苯丙香豆素的口服抗凝(OAC)治疗的证据很少。本研究的目的是评估 HF 的存在对基于苯丙香豆素的 OAC 质量和随后的临床结果的影响。在多中心 thrombEVAL 研究项目(NCT01809015)的常规护理队列(n=2011)中,根据 HF 的存在对 OAC 治疗质量和不良事件发生率进行了分析。为了评估结果的可修改性,将结果与接受抗凝专业护理的个体的数据(n=760)进行了比较。总体而言,常规护理队列中包含 813 名 HF 患者和 1160 名无 HF 患者。通过治疗范围时间(TTR)评估的 OAC 质量为 HF 患者 66.1%(47.8%/82.8%),无 HF 患者 70.6%(52.1%/85.9%)(=0.0046)。根据纽约心脏协会(NYHA)分级进行分层显示,随着 NYHA 分级的升高,TTR 降低:TTR 69.6%(49.4%/85.6%),TTR 66.5%(50.1%/82.9%)和 TTR 61.8%(43.1%/79.9%)。这导致 HF 的净临床获益结果更差(风险比[HR]1.63[1.31/2.02];<0.0001),出血风险增加(HR 1.40[1.04/1.89];=0.028)。在专门的凝血服务中进行管理可改善所有 TTR(增加+12.5%)、抗凝特异性和非特异性 HF 个体的结果。总之,HF 是 OAC 治疗质量低的独立危险因素,会增加不良事件的风险,而专门的护理可以减轻这种风险。

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