Characteristics, treatment, and outcomes of early vs. late enrollees of the STRONG-HF trial
Year: 2024
Type: article
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.
Source: American Heart Journal
Authors: Mattia Arrigo, Beth Davison, Christopher Edwards, Marianna Adamo, Andrew P. Ambrosy, Marianela Barros, Jan Biegus, Jelena Celutkiene, Kamilė Čerlinskaitė-Bajorė, Ovidiu Chioncel, Alain Cohen-Solal, Albertino Damasceno, Rafael Diaz, Gerasimos Filippatos, Etienne Gayat, Antoine Kimmoun, Carolyn S.P. Lam, Marco Metra, Maria Novosadova, Matteo Pagnesi, Peter S. Pang, Piotr Ponikowski, Hadiza Saidu, Karen Sliwa, Koji Takagi, Jozine M. Ter Maaten, Daniela Tomasoni, Adriaan A. Voors, Gad Cotter, Alexandre Mebazaa
Institutions: Stadtspital Zürich, Université Paris Cité, Momentum Research, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, University of Brescia, Kaiser Permanente, Kaiser Permanente Northern California, Wroclaw Medical University, Vilnius University, Carol Davila University of Medicine and Pharmacy, Hôpital Lariboisière, Eduardo Mondlane University, Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, National and Kapodistrian University of Athens, Inserm, Centre Hospitalier Régional et Universitaire de Nancy, Défaillance Cardiovasculaire Aiguë et Chronique, Université de Lorraine, National University of Singapore, National University Heart Centre Singapore, National Heart Centre Singapore, Indiana University Indianapolis, Indiana University School of Medicine, Bayero University Kano, University of Cape Town, Groote Schuur Hospital, University Medical Center Groningen, University of Groningen, Assistance Publique – Hôpitaux de Paris
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $3,950
OpenAlex ID: W4396847529