Abstract

To assess the potential interaction between noncardiac comorbidities (NCCs) and the efficacy and safety of high intensity care (HIC) versus usual care (UC) in STRONG-HF trial, including stable patients with improved but still elevated NPs METHODS AND RESULTS: In the trial, 8 NCCs were reported: anemia, diabetes, renal dysfunction, severe liver disease, COPD/asthma, stroke/TIA, psychiatric/neurological disorders, and malignancies. Patients were classified by NCC number (0, 1, 2 and ≥3). The treatment effect of HIC versus UC on the primary endpoint, 180-day death or HF-rehospitalization, was compared by NCC number and by each individual comorbidity. Among the 1078 patients, the prevalence of 0, 1, 2 and ≥3 NCCs was 24.3%, 39.8%, 24.5% and 11.3%. Achievement of full doses of HF-therapies at 90- and 180-days in the HIC was similar irrespective of NCCs number. In the HIC, the primary endpoint occurred in 10.0%, 16,6%, 13,6% and 26,2%, in those with 0, 1, 2 and ≥3 NCCs, as compared to 19,1%, 25,4%, 23,3% and 26,2% in UC (interaction-p=0.80). The treatment benefit of HIC vs. UC on the primary endpoint didn't differ significantly by each individual comorbidity. There was no significant treatment interaction by NCC number in quality-of-life improvement (p=0.98) or the incidence of serious adverse events (p=0.11). In the STRONG-HF trial, non-cardiac comorbidities neither limited the rapid up-titration of HF-therapies, nor attenuated the benefit of HIC on primary endpoint. In the context of a clinical trial, the benefit-risk ratio favors the rapid up-titration of HF-therapies even in patients with multiple NCCs This article is protected by copyright. All rights reserved.

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