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Noninferiority of heart failure nurse titration versus heart failure cardiologist titration. ETIFIC multicenter randomized trial.

Authors
  • Oyanguren, Juana1
  • Garcia-Garrido, Lluisa2
  • Nebot-Margalef, Magdalena3
  • Latorre-García, Pedro4
  • Torcal-Laguna, Jesús4
  • Comín-Colet, Josep3
  • Roure, Julia2
  • González-Costello, José3
  • Manito, Nicolás3
  • García-Pinilla, José M5
  • Sánchez-Paule, Yolanda5
  • Varela-Román, Alfonso6
  • Moure, María6
  • Segovia-Cubero, Javier7
  • Soria, Teresa7
  • Arana-Arri, Eunate4
  • Lekuona, Iñaki8
  • 1 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. Electronic address: [email protected] , (Spain)
  • 2 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. , (Spain)
  • 3 Unidad de Insuficiencia Cardiaca Avanzada y Trasplante Cardiaco, Servicio de Cardiología, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain; Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), Barcelona, Spain. , (Spain)
  • 4 BIOCRUCES, Instituto de Investigación Sanitaria, Bizkaia, Spain. , (Spain)
  • 5 Unidad de Insuficiencia Cardiaca, Servicio de Cardiología, Hospital Virgen de la Victoria, Málaga, Spain; Instituto de Investigación Sanitaria (IDIMA), Málaga, Spain. , (Spain)
  • 6 Unidad de Insuficiencia Cardiaca, Servicio de Cardiología, Hospital Universitario de Santiago, Santiago de Compostela, La Coruña, Spain; Instituto de Investigación Sanitaria de Santiago de Compostela (IDIS), La Coruña, Spain. , (Spain)
  • 7 Unidad de Insuficiencia Cardiaca Avanzada y Trasplante Cardiaco, Servicio de Cardiología, Hospital Puerta de Hierro Majadahonda, Majadahonda, Madrid, Spain. , (Spain)
  • 8 Servicio de Cardiología, Hospital Universitario Galdakao-Usansolo, OSI Barrualde-Galdakao-Osakidetza, Servicio Vasco de Salud, Galdakao, Bizkaia, Spain. , (Spain)
Type
Published Article
Journal
Revista espanola de cardiologia (English ed.)
Publication Date
Jun 01, 2021
Volume
74
Issue
6
Pages
533–543
Identifiers
DOI: 10.1016/j.rec.2020.04.016
PMID: 32591295
Source
Medline
Keywords
Language
Spanish
License
Unknown

Abstract

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. 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. 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. 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. Copyright © 2020 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

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