Effect of Qishen Yiqi dripping pills on the classification of ejection fraction in patients with ischaemic heart failure: A prospective cohort study

Abstract

Background

In patients with heart failure (HF), improved left ventricular ejection fraction (LVEF) classification is closely associated with increased survival rates. However, even patients receiving guideline-directed medical therapy (GDMT) still struggle with poor cardiac function and high rates of readmission. Enhancing cardiac function in HF patients and reducing the occurrence of adverse events (AEs) remain critical challenges at present.

Purpose

This study was designed to evaluate the effects of the Qishen Yiqi dripping pills (QSYQ) on the EF classification of patients with ischaemic HF (IHF).

Study design and methods

This is a secondary analysis of data from a multicentre, prospective cohort study involving 1,225 patients with IHF from 84 centres. We selected IHF patients with reduced (HFrEF) and mildly reduced (HFmrEF) EF. One-to-one propensity score matching (PSM) was performed to compare patients who received GDMT alone (control group) with patients who received additional treatment with QSYQ (QSYQ group). The primary outcome was the longitudinal improvement in EF at 90 days, defined as a change in EF classification from HFrEF to HFmrEF/HFpEF (HF with preserved EF) or from HFmrEF to HFpEF, with an increase in EF of at least 10 %. The secondary outcome was a composite endpoint consisting of all-cause mortality, hospitalization for HF, hospitalization for unstable angina, revascularization, nonfatal stroke, and malignant arrhythmias. Additionally, the New York Heart Association (NYHA) functional classification, Minnesota Living with Heart Failure Questionnaire (MLHFQ) scores, and safety were evaluated.

Results

Compared with the control treatment, the addition of QSYQ treatment for 90 days led to a 28 % increase in the improvement rate of EF classification in HFmEF or HFmrEF patients (RR: 1.28; 95 % CI: 1.03–1.59; p = 0.023), a 50 % reduction in the occurrence of composite endpoints (HR: 0.50; 95 % CI: 0.25–0.99; p = 0.04), a 40 % increase in the improvement rate of NYHA functional classification (RR: 1.40; 95 % CI: 1.26–1.55; p < 0.001), and a greater reduction in MLHFQ scores (-16.00 (-7.00, -27.00) vs. -8.00 (-1.00, -17.00), p < 0.001). Additionally, no increased risk of AEs was observed with the use of the QSYQ.

Conclusions

As a complementary strategy in addition to HF guideline-directed treatments, QSYQ can further improve EF classification, reduce the occurrence rate of the composite endpoint, improve quality of life, and improve the safety profile of patients with IHF. The study protocol is registered with the Chinese Clinical Trial Registry (ChiCTR-ONRC-14,004,407).