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Guideline-Directed Medical Therapy Use in the STRONG-HF Trial
Xiang Zhang1, Beth Davison2,3,4, Marianna Adamo5
1Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (X.Z., J.A.E.).
Insights
A new GDMT intensity score effectively measures heart failure medication use and is linked to improved clinical outcomes. This standardized approach offers a comprehensive assessment beyond traditional trial methods.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Assessing medication changes in heart failure (HF) trials is complex and may not fully represent patient care.
- A need exists for a comprehensive and standardized method to evaluate guideline-directed medical therapies (GDMT) in HF.
- The STRONG-HF trial provides a platform to assess GDMT intensity and its association with clinical outcomes.
Purpose of the Study:
- To evaluate the utility of a GDMT intensity score for assessing medication use in heart failure patients.
- To examine the association between GDMT intensity score and clinical outcomes in the STRONG-HF trial.
- To compare GDMT adherence and intensity between usual care and high-intensity care strategies.
Main Methods:
- Utilized data from the STRONG-HF trial, including baseline and follow-up assessments.
- Applied a GDMT intensity score to evaluate medication use and adherence (basic, indication-corrected, dose-corrected).
- Correlated GDMT intensity score with clinical outcomes up to 180 days post-intervention.
Main Results:
- High-intensity care significantly increased triple therapy indication-corrected and dose-corrected use compared to usual care at 90 days (P<0.001).
- At 90 days, 88.4% of patients in the high-intensity arm achieved a GDMT intensity score >7 versus 14.3% in the usual care arm (P<0.0001).
- The GDMT intensity score at baseline and 90 days was correlated with improved clinical outcomes at 180 days.
Conclusions:
- The GDMT intensity score offers a standardized and comprehensive measure of medication use in heart failure.
- This score is significantly associated with clinical outcomes, highlighting its prognostic value.
- The GDMT intensity score should be considered as a potential trial endpoint in future heart failure studies.
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.
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