Abstract
PURPOSE: This study aimed to evaluate whether the effect of Qishen Yiqi dropping pills (QSYQ) on the clinical outcome of patients with chronic ischemic heart failure (IHF) is related to the history of revascularization. PATIENTS AND METHODS: An exploratory post-hoc analysis was conducted using data from the CACT-IHF trial, a multicenter, randomized, double-blind, placebo-controlled study involving 640 patients with chronic IHF. Participants were randomized to receive either QSYQ or placebo for a duration of 6 months in addition to standard therapy, with a minimum follow-up period of 12 months. RESULTS: Among 638 patients (319 QSYQ, 319 placebo) in modified Intention-to-Treat (mITT) population (patients receive at least one trial drug or placebo treatment after randomization), 54.5% had prior revascularization. In the revascularized subgroup, QSYQ significantly reduced the risk of major adverse cardiac events (MACEs) (HR: 0.55, 95% CI: 0.36 to 0.82; P=0.003), second composite endpoint (HR: 0.60, 95% CI: 0.39 to 0.92; P=0.02) and hospitalization for heart failure (HHF) (HR: 0.57, 95% CI: 0.36 to 0.91; P=0.018) compared to placebo, while no significant difference was observed in non-revascularized patients. A significant interaction between revascularization and QSYQ treatment was noted (Pinteraction=0.009). It is suggested that the effect of QSYQ on the outcome of IHF patients is related to the history of revascularization. Adverse event rates were similar between groups. CONCLUSION: QSYQ reduces MACEs risk in revascularized chronic IHF patients without increasing adverse events, suggesting its potential as a safe and effective adjunct therapy. REGISTRATION: Clinical Trial Registry Identifier: NCT01555320.