What is the clinical evidence from this study?

Study design: Observational. Population: Heart failure with reduced ejection fraction (HFrEF) (n=1187). Intervention: Sacubitril/valsartan vs. None (Single-arm). Primary outcome: Cardiovascular death or first unplanned heart failure hospitalization (events per 100 patient-years).

What does this research mean for the field?

The PREDICT-HF model accurately predicts cardiovascular death or heart failure hospitalization in real-world Asian patients with HFrEF receiving sacubitril/valsartan, achieving a C-statistic of 0.73 at 2 years. Novelty: ClaimNovelty.CONFIRMATORY. Consensus alignment: ConsensusAlignment.NEUTRAL.

July 25, 2022Open Access

Utility of PREDICT-HF score in high-risk Asian heart failure patients receiving sacubitril/valsartan

CHChien‐Yi HsuNational Taiwan University HCHung‐Yu ChangNational Yang Ming Chiao Tung University CCChieh‐Ju ChaoCardiac Imaging

Key Result

In a real-world cohort of Asian patients with HFrEF receiving sacubitril/valsartan, the PREDICT-HF model accurately predicted cardiovascular death or heart failure hospitalization with a C-statistic of 0.73 at 2 years.

Study Design

Type

Observational (n=1,187)

Multicenter

Yes

Structured PICO

Population

1,187 outpatients with HFrEF (LVEF ≤40%, NYHA II-IV) in Taiwan, mean age 61.7, 23.7% female. Categorized into high-risk (n=305, defined as ≥1 of: age ≥80 years, systolic blood pressure <100 mmHg, eGFR <30 ml/min/1.73 m2) and standard-risk (n=882, no risk factors).

Intervention

Sacubitril/valsartan initiated at an outpatient department (mean daily dose at initiation 116 ± 56 mg/day)

Outcome

Composite of cardiovascular death or first unplanned heart failure hospitalization (HFH) at 1 and 2 years, assessed using the PREDICT-HF risk modelcomposite

The PREDICT-HF risk model accurately predicts clinical outcomes in real-world Asian patients with HFrEF receiving sacubitril/valsartan, including high-risk patients often excluded from clinical trials.

Limitations

Retrospective design with potential unmeasured bias
Missing laboratory data (total bilirubin and natriuretic peptide) in 30-40% of patients

Abstract

Objective The aim of this study was to investigate the application of sacubitril/valsartan in clinical practice and the utility of PREDICT-HF score for outcome prediction in Asian heart failure patients with difference risk profiles. Methods The TAROT-HF study was a multicenter, single-arm, observational study. Totally 1,187 outpatients with HFrEF treated with sacubitril/valsartan were enrolled and categorized by: (1) high-risk group with ≥1 of the following three risk factors: old age (≥80 years), low baseline systolic blood pressure (100 mmHg), and renal impairment (eGFR 30 ml/min/1.73 m 2 ), and (2) standard-risk group, those who did not have any risk factors. Clinical outcomes were assessed using the PREDICT-HF risk model. Results A total of 305 (25.7%) patients matched the criteria for the high-risk group. The event rates of cardiovascular death or first unplanned heart failure hospitalization (HFH) among the overall population, high-risk, and standard-risk groups were 13.7, 24.9, and 10.8 events per 100 patient-years, respectively. The C statistics for the PREDICT-HF model in the overall cohort and high-risk group for cardiovascular death or first unplanned HFH at 2 years were 0.73 (95% CI 0.70–0.76) and 0.71 (95% CI 0.65–0.76), respectively. The permanent discontinuation rate among the high-risk patients was significantly higher than that among the standard-risk patients (8.3 vs. 2.5 per 100 patient-years, p 0.001). Conclusions Real-world outcomes of the TAROT-HF study demonstrated that the PREDICT-HF model performed well in Asian HFrEF patients. Three easily detected clinical profiles of age, renal function, and systolic BP could help to identify patients at risk before initiating sacubitril/valsartan.

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