Zhang Xiang, Davison Beth, Adamo Marianna, Arrigo Mattia, Biegus Jan, Chioncel Ovidiu, Cohen-Solal Alain, Cotter Gad, Edwards Christopher, Kimmoun Antoine, Lam Carolyn S P, Mebazaa Alexandre, Metra Marco, Novosadova Maria, Pang Peter S, Sliwa Karen, Takagi Koji, Voors Adriaan A, Ezekowitz Justin A
Canadian VIGOUR Centre, University of Alberta, Edmonton, Canada (X.Z., J.A.E.).
Heart Initiative, Durham, NC (B.D., G.C.).
Circ Heart Fail. 2025 Jul 3:e012716. doi: 10.1161/CIRCHEARTFAILURE.124.012716.
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.
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.
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 (<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 (<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 (<0.0001). The GDMT intensity score was correlated with clinical outcomes at 180 days.
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.
URL: https://www.clinicaltrials.gov; Unique identifier: NCT03412201.
在心力衰竭试验和登记研究中评估药物治疗的变化很复杂，可能无法涵盖全部治疗情况。因此需要一种全面且标准化的方法。我们采用不同方法评估指南导向药物治疗（GDMT）的使用情况，并验证了GDMT强度评分与STRONG-HF试验（心力衰竭治疗的NT-proBNP检测助力快速优化的安全性、耐受性和有效性）临床结局之间的关联。
我们使用STRONG-HF试验的数据，通过应用GDMT强度评分来检查所有随机分组患者的基线GDMT使用情况，并评估其随时间的变化。我们还检查了他们的基本依从性、适应症校正依从性和剂量校正依从性，以及与长达180天临床结局的关联。
在90天时，常规治疗组三联疗法的适应症校正使用率从4.5%增至36%，高强度治疗组从5.2%增至93.5%（两组间<0.001）。常规治疗组三联疗法的剂量校正使用率从4.5%增至20.5%，高强度治疗组从3.3%增至77.4%（<0.001）。基线时，358例（33%）患者的GDMT强度评分为<6，329例（31%）患者为6至7，386例（36%）患者>7。在90天时，高强度治疗组88.4%的患者评分>7，而常规治疗组为14.3%（<0.0001）。GDMT强度评分与180天时的临床结局相关。
GDMT强度评分通过标准化测量对药物使用情况进行了全面描述，并与临床结局相关联。未来研究应考虑将其用作试验终点。
