Mattia Arrigo MD , Beth Davison PhD , Christopher Edwards BS , Marianna Adamo MD , Andrew P. Ambrosy MD , Marianela Barros MD , Jan Biegus MD , Jelena Celutkiene MD , Kamilė Čerlinskaitė-Bajorė MD , Ovidiu Chioncel MD , Alain Cohen-Solal MD PhD , Albertino Damasceno MD PhD , Rafael Diaz MD , Gerasimos Filippatos MD , Etienne Gayat MD PhD , Antoine Kimmoun MD PhD , Carolyn S.P. Lam MD PhD , Marco Metra MD , Maria Novosadova MD , Matteo Pagnesi MD , Alexandre Mebazaa MD PhD
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We hypothesized that significant differences in patient characteristics, management, and outcomes over the enrolment period may exist.</p></div><div><h3>Methods</h3><p>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).</p></div><div><h3>Results</h3><p>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, <em>P</em> = .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-<em>P</em> = .013) and at 90 days (interaction-<em>P</em> < .001). No interaction was observed for safety events. Patients randomized late to UC displayed a trend toward more severe outcomes (26% vs. 16%, <em>P</em> = .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-<em>P</em> = .51) with similar outcomes in the HIC arm in late and early enrollees (16% vs. 13%, <em>P</em> = .73).</p></div><div><h3>Conclusions</h3><p>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.</p></div><div><h3>Trial registration</h3><p>ClinicalTrials.gov Identifier: NCT03412201.</p></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":null,"pages":null},"PeriodicalIF":3.7000,"publicationDate":"2024-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0002870324001066/pdfft?md5=b31c009e863a0c10f74ef6385298c412&pid=1-s2.0-S0002870324001066-main.pdf","citationCount":"0","resultStr":"{\"title\":\"Characteristics, treatment, and outcomes of early vs. late enrollees of the STRONG-HF trial\",\"authors\":\"Mattia Arrigo MD , Beth Davison PhD , Christopher Edwards BS , Marianna Adamo MD , Andrew P. Ambrosy MD , Marianela Barros MD , Jan Biegus MD , Jelena Celutkiene MD , Kamilė Čerlinskaitė-Bajorė MD , Ovidiu Chioncel MD , Alain Cohen-Solal MD PhD , Albertino Damasceno MD PhD , Rafael Diaz MD , Gerasimos Filippatos MD , Etienne Gayat MD PhD , Antoine Kimmoun MD PhD , Carolyn S.P. Lam MD PhD , Marco Metra MD , Maria Novosadova MD , Matteo Pagnesi MD , Alexandre Mebazaa MD PhD\",\"doi\":\"10.1016/j.ahj.2024.04.019\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>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.</p></div><div><h3>Methods</h3><p>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).</p></div><div><h3>Results</h3><p>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, <em>P</em> = .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-<em>P</em> = .013) and at 90 days (interaction-<em>P</em> < .001). No interaction was observed for safety events. Patients randomized late to UC displayed a trend toward more severe outcomes (26% vs. 16%, <em>P</em> = .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-<em>P</em> = .51) with similar outcomes in the HIC arm in late and early enrollees (16% vs. 13%, <em>P</em> = .73).</p></div><div><h3>Conclusions</h3><p>Late enrollees have different clinical characteristics and higher event rates compared to early enrollees. 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Characteristics, treatment, and outcomes of early vs. late enrollees of the STRONG-HF trial
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.
期刊介绍：
The American Heart Journal will consider for publication suitable articles on topics pertaining to the broad discipline of cardiovascular disease. Our goal is to provide the reader primary investigation, scholarly review, and opinion concerning the practice of cardiovascular medicine. We especially encourage submission of 3 types of reports that are not frequently seen in cardiovascular journals: negative clinical studies, reports on study designs, and studies involving the organization of medical care. The Journal does not accept individual case reports or original articles involving bench laboratory or animal research.
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