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心脏-肾脏-代谢综合征:真实世界心力衰竭队列中的临床特征和达格列净的适用条件。

Cardio-renal-metabolic syndrome: clinical features and dapagliflozin eligibility in a real-world heart failure cohort.

机构信息

Cardiovascular Research Centre, OLV Hospital, Moorselbaan 164, 9300, Aalst, Belgium.

LynxCare Inc., LynxCare Clinical Informatics N.V., Leuven, Belgium.

出版信息

ESC Heart Fail. 2023 Aug;10(4):2269-2280. doi: 10.1002/ehf2.14381. Epub 2023 Apr 24.

Abstract

AIMS

The Cardiovascular Outcomes Retrospective Data analysIS in Heart Failure (CORDIS-HF) is a single-centre retrospective study aimed to (i) clinically characterize a real-world population with heart failure (HF) with reduced (HFrEF) and mildly reduced ejection fraction (HFmrEF), (ii) evaluate impact of renal-metabolic comorbidities on all-cause mortality and HF readmissions, and (iii) determine patients' eligibility for sodium-glucose cotransporter 2 inhibitors (SGLT2is).

METHODS AND RESULTS

Using a natural language processing algorithm, clinical data of patients diagnosed with HFrEF or HFmrEF were retrospectively collected from 2014 to 2018. Mortality and HF readmission events were collected during subsequent 1 and 2 year follow-up periods. The predictive role of patients' baseline characteristics for outcomes of interest was assessed using univariate and multivariate Cox proportional hazard models. Kaplan-Meier analysis was used to determine if type 2 diabetes (T2D) and chronic kidney disease (CKD) impacted mortality and HF readmission rates. The European SGLT2i label criteria were used to assess patients' eligibility. The CORDIS-HF included 1333 HF patients with left ventricular ejection fraction (LVEF) < 50% (413 HFmrEF and 920 HFrEF), who were predominantly male (69%) with a mean [standard deviation (SD)] age of 74.7 (12.3) years. About one-half (57%) of patients presented CKD and 37% T2D. The use of guideline-directed medical therapy (GDMT) was high (76-90%). HFrEF patients presented lower age [mean (SD): 73.8 (12.4) vs. 76.7 (11.6) years, P < 0.05], higher incidence of coronary artery disease (67% vs. 59%, P < 0.05), lower systolic blood pressure [mean (SD): 123 (22.6) vs. 133 (24.0) mmHg, P < 0.05], higher N-terminal pro-hormone brain natriuretic peptide (2720 vs. 1920 pg/mL, P < 0.05), and lower estimated glomerular filtration rate [mean (SD): 51.4 (23.3) vs. 54.1 (22.3) mL/min/1.73 m , P < 0.05] than those with HFmrEF. No differences in T2D and CKD were detected. Despite optimal treatment, event rates for the composite endpoint of HF readmission and mortality were 13.7 and 8.4/100 patient years. The presence of T2D and CKD negatively impacted all-cause mortality [T2D: hazard ratio (HR) = 1.49, P < 0.01; CKD: HR = 2.05, P < 0.001] and hospital readmission events in all patients with HF. Eligibility for SGLT2is dapagliflozin and empagliflozin was 86.5% (n = 1153) and 97.9% (n = 1305) of the study population, respectively.

CONCLUSIONS

This study identified high residual risk for all-cause mortality and hospital readmission in real-world HF patients with LVEF < 50% despite GDMT. T2D and CKD aggravated the risk for these endpoints, indicating the intertwinement of HF with CKD and T2D. SGLT2i treatment that clinically benefits these different disease conditions can be an important driver to lower mortality and hospitalizations in this HF population.

摘要

目的

心力衰竭的回顾性数据分析(CORDIS-HF)是一项单中心回顾性研究,旨在:(i)从临床角度描述射血分数降低(HFrEF)和轻度降低(HFmrEF)的心力衰竭(HF)真实世界人群;(ii)评估肾脏代谢合并症对全因死亡率和 HF 再入院的影响;(iii)确定患者是否适合使用钠-葡萄糖共转运蛋白 2 抑制剂(SGLT2i)。

方法和结果

使用自然语言处理算法,从 2014 年至 2018 年回顾性地收集了诊断为 HFrEF 或 HFmrEF 的患者的临床数据。在随后的 1 年和 2 年随访期间收集死亡率和 HF 再入院事件。使用单变量和多变量 Cox 比例风险模型评估患者基线特征对感兴趣结局的预测作用。Kaplan-Meier 分析用于确定 2 型糖尿病(T2D)和慢性肾脏病(CKD)是否影响死亡率和 HF 再入院率。使用欧洲 SGLT2i 标签标准评估患者的资格。CORDIS-HF 纳入了 1333 名左心室射血分数(LVEF)<50%的 HF 患者(413 名 HFmrEF 和 920 名 HFrEF),主要为男性(69%),平均年龄(标准差)为 74.7(12.3)岁。约一半(57%)的患者存在 CKD,37%的患者存在 T2D。指南指导的药物治疗(GDMT)的使用率较高(76-90%)。HFrEF 患者年龄较低[平均(标准差):73.8(12.4)比 76.7(11.6)岁,P<0.05],冠状动脉疾病发生率较高(67%比 59%,P<0.05),收缩压较低[平均(标准差):123(22.6)比 133(24.0)mmHg,P<0.05],N 末端前脑钠肽原(NT-proBNP)较高(2720 比 1920 pg/mL,P<0.05),肾小球滤过率估计值较低[平均(标准差):51.4(23.3)比 54.1(22.3)mL/min/1.73 m ,P<0.05]。但 T2D 和 CKD 之间无差异。尽管进行了最佳治疗,但 HF 再入院和死亡率的复合终点发生率为 13.7%和 8.4/100 患者年。T2D(危险比[HR]1.49,P<0.01)和 CKD(HR 2.05,P<0.001)的存在对所有 HF 患者的全因死亡率和住院再入院事件有负面影响。SGLT2i 达格列净和恩格列净的适应证分别为研究人群的 86.5%(n=1153)和 97.9%(n=1305)。

结论

尽管进行了 GDMT,但这项研究发现,射血分数<50%的真实世界 HF 患者仍存在全因死亡率和 HF 再入院的高残余风险。T2D 和 CKD 加重了这些终点的风险,表明 HF 与 CKD 和 T2D 的交织。SGLT2i 治疗可使这些不同疾病状况的患者临床获益,可能是降低该 HF 人群死亡率和住院率的重要驱动因素。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6101/10375172/0355ce1e1aec/EHF2-10-2269-g003.jpg

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