心力衰竭护士滴定与心力衰竭心脏病专家滴定的非劣效性。ETIFIC 多中心随机试验。
Noninferiority of heart failure nurse titration versus heart failure cardiologist titration. ETIFIC multicenter randomized trial.
机构信息
Servicio de Cardiología, Hospital Universitario Galdakao-Usansolo, OSI Barrualde-Galdakao-Osakidetza, Servicio Vasco de Salud, Galdakao, Bizkaia, Spain; BIOCRUCES, Instituto de Investigación Sanitaria, Bizkaia, Spain.
Unidad de Insuficiencia Cardiaca, Servicio de Cardiología, Hospital Universitario Dr. Josep Trueta, Girona, Spain; Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta (IDIBGI), Girona, Spain.
出版信息
Rev Esp Cardiol (Engl Ed). 2021 Jun;74(6):533-543. doi: 10.1016/j.rec.2020.04.016. Epub 2020 Jun 24.
INTRODUCTION AND OBJECTIVES
Beta-blockers, angiotensin-converting enzyme inhibitors (ACE inhibitors), angiotensin-II-receptor-blockers (ARB), and mineralocorticoid-receptor antagonists decrease mortality and heart failure (HF) hospitalizations in HF patients with reduced left ventricular ejection fraction. The effect is dose-dependent. Careful titration is recommended. However, suboptimal doses are common in clinical practice. This study aimed to compare the safety and efficacy of dose titration of the aforementioned drugs by HF nurses vs HF cardiologists.
METHODS
ETIFIC was a multicenter (n=20) noninferiority randomized controlled open label trial. A total of 320 hospitalized patients with new-onset HF, reduced ejection fraction and New York Heart Association II-III, without beta-blocker contraindications were randomized 1:1 in blocks of 4 patients each stratified by hospital: 164 to HF nurse titration vs 156 to HF cardiologist titration (144 vs 145 analyzed). The primary endpoint was the beta-blocker mean relative dose (% of target dose) achieved at 4 months. Secondary endpoints included ACE inhibitors, ARB, and mineralocorticoid-receptor antagonists mean relative doses, associated variables, adverse events, and clinical outcomes at 6 months.
RESULTS
The mean±standard deviation relative doses achieved by HF nurses vs HF cardiologists were as follows: beta-blockers 71.09%±31.49% vs 56.29%±31.32%, with a difference of 14.8% (95%CI, 7.5-22.1), P <.001; ACE inhibitors 72.61%±29.80% vs 56.13%±30.37%, P <.001; ARB 44.48%±33.47% vs 43.51%±33.69%, P=.93; and mineralocorticoid-receptor antagonists 71%±32.12% vs 70.47%±29.78%, P=.86; mean±standard deviation visits were 6.41±2.82 vs 2.81±1.58, P <.001, while the number (%) of adverse events were 34 (23.6) vs 30 (20.7), P=.55; and at 6 months HF hospitalizations were 1 (0.69) vs 9 (5.51), P=.01.
CONCLUSIONS
ETIFIC is the first multicenter randomized trial to demonstrate the noninferiority of HF specialist-nurse titration vs HF cardiologist titration. Moreover, HF nurses achieved higher beta-blocker/ACE inhibitors doses, with more outpatient visits and fewer HF hospitalizations. Trial registry number: NCT02546856.
简介和目的
β受体阻滞剂、血管紧张素转换酶抑制剂（ACEI）、血管紧张素 II 受体阻滞剂（ARB）和盐皮质激素受体拮抗剂可降低左心室射血分数降低的心力衰竭（HF）患者的死亡率和心力衰竭（HF）住院率。这种作用是剂量依赖性的。建议谨慎滴定。然而，在临床实践中，通常存在剂量不足的情况。本研究旨在比较 HF 护士和 HF 心脏病专家对上述药物进行剂量调整的安全性和疗效。
方法
ETIFIC 是一项多中心（n=20）非劣效性随机对照开放标签试验。共纳入 320 例新发 HF、射血分数降低和纽约心脏协会 II-III 级、无β受体阻滞剂禁忌证的住院患者，按医院分层（每组 4 例）进行 1:1 随机分组：164 例接受 HF 护士滴定治疗，156 例接受 HF 心脏病专家滴定治疗（144 例 vs 145 例进行分析）。主要终点是 4 个月时达到的β受体阻滞剂平均相对剂量（目标剂量的%）。次要终点包括 ACEI、ARB 和盐皮质激素受体拮抗剂的平均相对剂量、相关变量、不良事件和 6 个月时的临床结局。
结果
HF 护士与 HF 心脏病专家达到的β受体阻滞剂平均相对剂量分别为：β受体阻滞剂 71.09%±31.49% vs 56.29%±31.32%，差异为 14.8%（95%CI，7.5-22.1），P<.001；ACEI 为 72.61%±29.80% vs 56.13%±30.37%，P<.001；ARB 为 44.48%±33.47% vs 43.51%±33.69%，P=.93；和盐皮质激素受体拮抗剂为 71%±32.12% vs 70.47%±29.78%，P=.86；平均随访次数为 6.41±2.82 次 vs 2.81±1.58 次，P<.001，而不良事件的数量（%）分别为 34（23.6）例 vs 30（20.7）例，P=.55；6 个月时 HF 住院率分别为 1（0.69）例 vs 9（5.51）例，P=.01。
结论
ETIFIC 是第一项多中心随机试验，证明 HF 专科护士滴定与 HF 心脏病专家滴定具有非劣效性。此外，HF 护士达到了更高的β受体阻滞剂/ACEI 剂量，门诊就诊次数更多，HF 住院次数更少。试验注册号：NCT02546856。
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