Guideline-Directed Medical Therapy Use in the STRONG-HF Trial
- PMID: 40605744
- DOI: 10.1161/CIRCHEARTFAILURE.124.012716
Guideline-Directed Medical Therapy Use in the STRONG-HF Trial
Abstract
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.
Keywords: clinical trial; guideline directed medical therapy; heart failure.
Conflict of interest statement
Dr Adamo has received speaker fees from Abbott Vascular and Medtronic. Dr Chioncel received grants from Servier. Dr Cohen-Solal has received honoraria for lectures or consultancy from AstraZeneca, Novartis, Vifor, Bayer, Merck, Sanofi, Abbott, and Boehringer Ingelheim. Dr Cotter is an employee of Momentum Research, which has received grants for research from 4TEEN4 Pharmaceuticals, Corteria Pharmaceuticals, Echosens, Heart Initiative, Roche Diagnostics, and Windtree Therapeutics. Dr Cotter is also director of Heart Initiative, a nonprofit organization. BD is an employee of Momentum Research, which has received grants for research from 4TEEN4 Pharmaceuticals, Corteria Pharmaceuticals, Echosens, Heart Initiative, Roche Diagnostics, and Windtree Therapeutics. Dr Davison is also director of Heart Initiative, a nonprofit organization. C. Edwards is an employee of Momentum Research, which has received grants for research from 4TEEN4 Pharmaceuticals, Corteria Pharmaceuticals, Echosens, Heart Initiative, Roche Diagnostics, and Windtree Therapeutics. Dr Lam is supported by a Clinician Scientist Award from the National Medical Research Council of Singapore; has received research support from Bayer and Roche Diagnostics; and has served as a consultant or on the Advisory Board/Steering Committee/Executive Committee for Actelion, Alleviant Medical, Allysta Pharma, Amgen, AnaCardio AB, Applied Therapeutics, AstraZeneca, Bayer, Boehringer Ingelheim, Boston Scientific, Cytokinetics, Darma, Inc, EchoNous, Inc, Eli Lilly, Impulse Dynamics, Intellia Therapeutics, Ionis Pharmaceutical, Janssen Research & Development LLC, Medscape/WebMD Global LLC, Merck, Novartis, Novo Nordisk, Prosciento, Inc, Radcliffe Group, Ltd, Redcardio, Inc, ReCor Medical, Roche Diagnostics, Sanofi, Siemens Healthcare Diagnostics, and Us2.ai; and serves as cofounder and nonexecutive director of Us2.ai. Dr Mebazaa has received grants from Roche Diagnostics, Abbott Laboratories, 4TEEN4, and Windtree Therapeutics; honoraria for lectures from Roche Diagnostics, Bayer, and MSD; is a consultant for Corteria Pharmaceuticals, S-form Pharma, FIRE-1, Implicity, 4TEEN4, and Adrenomed; and is coinventor of a patent on combination therapy for patients having acute or persistent dyspnea. Dr Metra has received personal fees from Actelion, Amgen, Livanova, and Vifor Pharma as a member of executive or data monitoring committees of sponsored clinical trials and from AstraZeneca, Bayer, Boehringer Ingelheim, Edwards Lifesciences, and Roche Diagnostics for participation to advisory boards or for speaking at sponsored meetings. Dr Novosadova is an employee of Momentum Research, which has received grants for research from Abbott Laboratories, Amgen, Celyad, Cirius Therapeutics, Corteria Pharmaceuticals, Heart Initiative, Sanofi, Windtree Therapeutics, and XyloCor Therapeutics. Dr Pang has received grants or research contracts from the American Heart Association, Roche, Siemens, Ortho Diagnostics, Abbott, Beckman Coulter, and Siemens; consulting fees from Roche; honoraria from WebMD; and he has a financial interest in The Heart Course. Dr Sliwa has received grants from Medtronic, Servier, and Amylam, and honoraria from MSD, Novartis, and Sanofi. Dr Takagi is an employee of Momentum Research, which has received grants for research from 4TEEN4 Pharmaceuticals, Corteria Pharmaceuticals, Echosens, Heart initiative, Roche diagnostics, and Windtree Therapeutics. Dr Voors has received consultancy fees or research support from AstraZeneca, Bayer, BMS, Boehringer Ingelheim, Cytokinetics, Myocardia, Merck, Novartis, Novo Nordisk, and Roche Diagnostics. The other authors report no conflicts.
Comment in
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Simultaneous or Rapid Sequence Optimization of Medical Therapy for Heart Failure: Time to Keep Score.Circ Heart Fail. 2025 Sep;18(9):e013417. doi: 10.1161/CIRCHEARTFAILURE.125.013417. Epub 2025 Aug 13. Circ Heart Fail. 2025. PMID: 40799134 No abstract available.
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