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Characteristics, treatment, and outcomes of early vs. late enrollees of the STRONG-HF trial.
Arrigo, Mattia; Davison, Beth; Edwards, Christopher; Adamo, Marianna; Ambrosy, Andrew P; Barros, Marianela; Biegus, Jan; Celutkiene, Jelena; Cerlinskaite-Bajore, Kamile; Chioncel, Ovidiu; Cohen-Solal, Alain; Damasceno, Albertino; Diaz, Rafael; Filippatos, Gerasimos; Gayat, Etienne; Kimmoun, Antoine; Lam, Carolyn S P; Metra, Marco; Novosadova, Maria; Pagnesi, Matteo; Pang, Peter S; Ponikowski, Piotr; Saidu, Hadiza; Sliwa, Karen; Takagi, Koji; Ter Maaten, Jozine M; Tomasoni, Daniela; Voors, Adriaan A; Cotter, Gad; Mebazaa, Alexandre.
Afiliação
  • Arrigo M; Department of Internal Medicine, Stadtspital Zurich, Zurich, Switzerland. Electronic address: mattia.arrigo@uzh.ch.
  • Davison B; Université Paris Cité, Paris, France; Heart Initiative, Durham, NC.
  • Edwards C; Momentum Research, Inc., Durham, NC.
  • Adamo M; Cardiology, ASST Spedali Civili and Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Brescia, Italy.
  • Ambrosy AP; Kaiser Permanente Northern California, Oakland CA, USA.
  • Barros M; Momentum Research, Inc., Durham, NC.
  • Biegus J; Institute of Heart Diseases, Wroclaw Medical University, Wroclaw, Poland.
  • Celutkiene J; Clinic of Cardiac and Vascular Diseases, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania.
  • Cerlinskaite-Bajore K; Clinic of Cardiac and Vascular Diseases, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania.
  • Chioncel O; Emergency Institute for Cardiovascular Diseases "Prof. C.C.Iliescu", University of Medicine "Carol Davila", Bucharest, Romania.
  • Cohen-Solal A; Université Paris Cité, Paris, France; Department of Cardiology, APHP Nord, Lariboisière University Hospital, Paris, France.
  • Damasceno A; Faculty of Medicine, Eduardo Mondlane University, Maputo, Mozambique.
  • Diaz R; Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina.
  • Filippatos G; National and Kapodistrian University of Athens, School of Medicine, Attikon University Hospital, Athens, Greece.
  • Gayat E; Heart Initiative, Durham, NC; Momentum Research, Inc., Durham, NC.
  • Kimmoun A; Université de Lorraine, Nancy; INSERM, Défaillance Circulatoire Aigue et Chronique; Service de Médecine Intensive et Réanimation Brabois, 54511 Vandœuvre-lès-Nancy, France.
  • Lam CSP; National Heart Centre Singapore and Duke-National University of Singapore.
  • Metra M; Cardiology, ASST Spedali Civili and Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Brescia, Italy.
  • Novosadova M; Momentum Research, Inc., Durham, NC.
  • Pagnesi M; Cardiology, ASST Spedali Civili and Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Brescia, Italy.
  • Pang PS; Department of Emergency Medicine, Department of Medicine, Indiana University School of Medicine, Indianapolis, IN.
  • Ponikowski P; Institute of Heart Diseases, Wroclaw Medical University, Wroclaw, Poland.
  • Saidu H; Department of Medicine, Murtala Muhammed Specialist Hospital / Bayero University Kano, Kano, Nigeria.
  • Sliwa K; Cape Heart Institute, Division of Cardiology, Department of Medicine, Groote Schuur Hospital and University of Cape Town, Cape Town, South Africa.
  • Takagi K; Momentum Research, Inc., Durham, NC.
  • Ter Maaten JM; University of Groningen, Department of Cardiology, University Medical Centre Groningen, Groningen, Netherlands.
  • Tomasoni D; Cardiology, ASST Spedali Civili and Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Brescia, Italy.
  • Voors AA; University of Groningen, Department of Cardiology, University Medical Centre Groningen, Groningen, Netherlands.
  • Cotter G; Université Paris Cité, Paris, France; Heart Initiative, Durham, NC.
  • Mebazaa A; Université Paris Cité, Paris, France; Department of Anesthesiology and Critical Care and Burn Unit, Saint-Louis and Lariboisière Hospitals, FHU PROMICE, DMU Parabol, APHP Nord, Paris, France.
Am Heart J ; 274: 119-129, 2024 08.
Article em En | MEDLINE | ID: mdl-38740532
ABSTRACT

BACKGROUND:

The STRONG-HF trial showed that high-intensity care (HIC) consisting of rapid up-titration of guideline-directed medical therapy (GDMT) and close follow-up reduced all-cause death or heart failure (HF) readmission at 180 days compared to usual care (UC). We hypothesized that significant differences in patient characteristics, management, and outcomes over the enrolment period may exist.

METHODS:

Two groups of the 1,078 patients enrolled in STRONG-HF were created according to the order of enrolment within center. The early group consisted of the first 10 patients enrolled at each center (N = 342) and the late group consisted of the following patients (N = 736).

RESULTS:

Late enrollees were younger, had more frequently reduced ejection fraction, slightly lower NT-proBNP and creatinine levels compared with early enrollees. The primary outcome occurred less frequently in early compared to late enrollees (15% vs. 21%, aHR 0.65, 95% CI 0.42-0.99, P = .044). No treatment-by-enrolment interaction was seen in respect to the average percentage of optimal dose of GDMT after randomization, which was consistently higher in early and late patients randomized to HIC compared to UC. The higher use of renin-angiotensin-inhibitors in the HIC arm was more pronounced in the late enrollees both after randomization (interaction-P = .013) and at 90 days (interaction-P < .001). No interaction was observed for safety events. Patients randomized late to UC displayed a trend toward more severe outcomes (26% vs. 16%, P = .10), but the efficacy of HIC showed no interaction with the enrolment group (aHR 0.77, 95% CI 0.35-1.67 in early and 0.58, 95% CI 0.40-0.83 in late enrollees, adjusted interaction-P = .51) with similar outcomes in the HIC arm in late and early enrollees (16% vs. 13%, P = .73).

CONCLUSIONS:

Late enrollees have different clinical characteristics and higher event rates compared to early enrollees. GDMT implementation in the HIC arm robustly achieved similar doses with consistent efficacy in early and late enrollees, mitigating the higher risk of adverse outcome in late enrollees. TRIAL REGISTRATION ClinicalTrials.gov Identifier NCT03412201.
Assuntos

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Volume Sistólico / Insuficiência Cardíaca Idioma: En Ano de publicação: 2024 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Volume Sistólico / Insuficiência Cardíaca Idioma: En Ano de publicação: 2024 Tipo de documento: Article