TY - JOUR
T1 - Characteristics, treatment, and outcomes of early vs. late enrollees of the STRONG-HF trial
AU - Arrigo, Mattia
AU - Davison, Beth
AU - Edwards, Christopher
AU - Adamo, Marianna
AU - Ambrosy, Andrew P.
AU - Barros, Marianela
AU - Biegus, Jan
AU - Celutkiene, Jelena
AU - Čerlinskaitė-Bajorė, Kamilė
AU - Chioncel, Ovidiu
AU - Cohen-Solal, Alain
AU - Damasceno, Albertino
AU - Diaz, Rafael
AU - Filippatos, Gerasimos
AU - Gayat, Etienne
AU - Kimmoun, Antoine
AU - Lam, Carolyn S.P.
AU - Metra, Marco
AU - Novosadova, Maria
AU - Pagnesi, Matteo
AU - Pang, Peter S.
AU - Ponikowski, Piotr
AU - Saidu, Hadiza
AU - Sliwa, Karen
AU - Takagi, Koji
AU - Ter Maaten, Jozine M.
AU - Tomasoni, Daniela
AU - Voors, Adriaan A.
AU - Cotter, Gad
AU - Mebazaa, Alexandre
N1 - Publisher Copyright:
© 2024 The Author(s)
PY - 2024/8
Y1 - 2024/8
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85194561668&partnerID=8YFLogxK
U2 - 10.1016/j.ahj.2024.04.019
DO - 10.1016/j.ahj.2024.04.019
M3 - Article
C2 - 38740532
AN - SCOPUS:85194561668
SN - 0002-8703
VL - 274
SP - 119
EP - 129
JO - American Heart Journal
JF - American Heart Journal
ER -