Key Points:
- Qiliqiangxin is a traditional Chinese herbal medicine extract which has been approved since 2004 for the treatment of HF in China.
- This multicenter, double-blind, placebo-controlled trial compared qiliqiangxin with placebo amongst patients with HFrEF (EF<40%). The primary endpoint was a composite of CV death and HF hospitalizations.
- Over a median follow-up of 18 months, qiliqiangxin use resulted in a reduction in the composite primary endpoint.
Qiliqiangxin is a traditional Chinese medicine extract derived from a compilation of 11 different herbs. This therapy is widely used in China after myocardial infarction to attenuate adverse cardiac remodeling and has been approved by the Chinese FDA for the treatment of chronic HF since 2004. In a breaking presentation at the 2023 ESC Congress today, Dr. Xinli Li and his team presented “Qiliqiangxin in heart failUre: assESsment of reduction in mortality,” or the QUEST study.
The QUEST trial was a randomized, double-blind, placebo-controlled multicenter trial of HFrEF patients treated with either qiliqiangxin or placebo in addition to a standard medication regimen for chronic heart failure. Participants were required to have an EF < 40%, elevated biomarkers (NTproBNP >450pg/ml), NYHA Class II-IV symptoms, and a stable baseline heart failure treatment regimen for at least two weeks prior to enrollment. Key exclusion criteria were age <18, uncontrolled hypertension, known or planned pregnancy, planned coronary revascularization or CRT placement at the time of randomization, or heart failure caused by secondary organ failure. The primary endpoint was a composite of major adverse cardiovascular events, including CV death and HF hospitalizations.
A total of 3,110 patients were 1:1 randomized to either qiliqiangxin (four capsules three times a day) or placebo. The mean age was 62, and 27.9% were women. The mean NT-proBNP was 1,731 pg/ml, and the mean EF was 32%. The median follow-up was 18.3 months. Participants receiving qiliqiangxin had a significantly greater reduction in the primary composite endpoint compared to placebo (HR 0.78, 95% CI 0.68-0.90, p<0.001). Participants receiving qiliqiangxin also experienced a significant reduction in both components of the primary endpoint, including both HF hospitalizations (HR 0.76, 95% CI 0.64-0.90, p=0.002) and CV death (HR 0.83, 95% CI 0.68-0.996, p=0.045). The effects of qiliqiangxin were consistent across the pre-specified subgroups of a)ischemic etiology of HF, b) concomitant use of triple therapy with RAASi + beta blockers + MRA, and c) baseline ARNi use. There were no differences in adverse events between the two groups.
When discussing the clinical implications of the study at the ESC Congress press conference, Dr. Li stated: “Among patients with HFrEF, the risk of hospitalization of HF or death from cardiovascular causes was lower amongst those who received qiliqiangxin capsules than among those who received placebo…this was the first randomized trial of a traditional Chinese medicine for the treatment of chronic heart failure.”