Dieterle Thomas, Schaefer Stefan, Meyer Ina, Ackermann Gabriele, Ahmed Kashan, Hullin Roger
University Department of Medicine, Cantonal Hospital Baselland, Liestal, Switzerland.
Faculty of Medicine, University of Basel, Basel, Switzerland.
ESC Heart Fail. 2020 Aug;7(4):1626-1634. doi: 10.1002/ehf2.12716. Epub 2020 May 5.
Switch from angiotensin converting enzyme inhibitor treatment to sacubitril/valsartan (sac/val) is associated with benefit in heart failure with reduced ejection fraction (HFrEF). Reports on management of this switch are largely based on randomized controlled trials, retrospective analyses, and hospital-based care, while patients with chronic heart failure (CHF) are frequently followed-up in primary care. The THESEUS study aimed to characterize the transition to sac/val and early maintenance period of HFrEF in primary care.
THESEUS was a prospective, observational, non-interventional study, performed at primary care sites throughout Switzerland. Patient characteristics, sac/val transition, and maintenance were reported at study enrolment and approximately 3 and 6 months after sac/val initiation. The primary endpoint was achievement of 200 mg BID sac/val with maintenance for ≥12 weeks. Secondary outcomes included dosing regimens, healthcare utilization in the 6 months prior to sac/val initiation and during the study, patient well-being, safety, and tolerability. Fifty-eight patients with CHF were enrolled from 45 primary care centres. Six patients were excluded, and 19 achieved the primary endpoint (36.5%, Achievers). Non-Achievers underwent fewer titration steps than Achievers (1.9 ± 0.9 vs. 3.1 ± 1.4). In both groups, patient well-being improved and the percentage of New York Heart Association III patients decreased. Healthcare utilization decreased (19% vs. 30.8% in the 6 months pre-enrolment period). The most frequent reasons for target dose non-achievement were asymptomatic and symptomatic hypotension (15.3% and 12.1%, respectively).
Results from THESEUS suggest that transition to sac/val is manageable in primary care, with a safety profile corresponding to reports from specialized heart failure care.
从血管紧张素转换酶抑制剂治疗转换为沙库巴曲缬沙坦（沙库/缬）治疗与射血分数降低的心力衰竭（HFrEF）患者获益相关。关于这种转换管理的报告主要基于随机对照试验、回顾性分析和基于医院的护理，而慢性心力衰竭（CHF）患者在初级保健中经常接受随访。THESEUS研究旨在描述在初级保健中向沙库/缬转换及HFrEF早期维持阶段的情况。
THESEUS是一项在瑞士各地初级保健机构进行的前瞻性、观察性、非干预性研究。在研究入组时以及沙库/缬起始后约3个月和6个月报告患者特征、沙库/缬转换及维持情况。主要终点是达到每日两次200mg沙库/缬并维持≥12周。次要结局包括给药方案、沙库/缬起始前6个月及研究期间的医疗资源利用、患者健康状况、安全性和耐受性。从45个初级保健中心招募了58例CHF患者。6例患者被排除，19例达到主要终点（36.5%，达标者）。未达标者比达标者经历的滴定步骤更少（1.9±0.9对3.1±1.4）。两组患者的健康状况均有所改善，纽约心脏协会III级患者的比例下降。医疗资源利用减少（入组前6个月为19%对30.8%）。未达到目标剂量的最常见原因是无症状和有症状的低血压（分别为15.3%和12.1%）。
THESEUS研究结果表明，在初级保健中向沙库/缬转换是可控 的，其安全性与专业心力衰竭护理报告一致。
