Guideline-Directed Medical Therapy Use in the STRONG-HF Trial

BACKGROUND: Assessment of medication changes in heart failure trials and registries is complex and may not capture the entirety of care. A comprehensive and standardized method is needed. We used different methods to assess the use of guideline-directed medical therapies (GDMT) and verified the association between GDMT intensity score with the STRONG-HF trial (Safety, Tolerability and Efficacy of Rapid Optimization, Helped by NT-proBNP Testing of Heart Failure Therapies) clinical outcomes. METHODS: We used data from the STRONG-HF trial to examine the baseline GDMT use for all randomized patients by applying the GDMT intensity score and evaluated its change over time. We also examined their basic adherence, indication-corrected adherence, and dose-corrected adherence, and the association with clinical outcomes up to 180 days. RESULTS: At 90 days, triple therapy indication-corrected use increased from 4.5% to 36% in the usual care group, and from 5.2% to 93.5% in the high-intensity care group ( P <0.001 between the 2 groups). Triple therapy dose-corrected use increased from 4.5% to 20.5% in the usual care group, and from 3.3% to 77.4% in the high-intensity care group ( P <0.001). The GDMT intensity score at baseline was <6 in 358 (33%) patients, 6 to 7 in 329 (31%) patients, and >7 in 386 (36%) patients. At 90 days, 88.4% of patients in the high-intensity arm achieved a score >7 versus 14.3% in the usual care arm ( P <0.0001). The GDMT intensity score was correlated with clinical outcomes at 180 days. CONCLUSIONS: The GDMT intensity score provides a comprehensive description of medication use by means of standardized measurements and is linked to clinical outcomes. Future studies should consider utilizing this as a trial end point. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03412201.