Xinyue capsule treatment on long-term outcomes in patients with stable coronary artery disease after PCI: A 10-year observational follow-up.

BACKGROUND

Although the randomized controlled trial (RCT) demonstrated that Xinyue capsule effectively reduced cardiovascular events within 1 year in stable coronary artery disease (CAD) patients post-PCI, the long-term benefits remain unclear. Therefore, the long-term effects of Xinyue capsule were investigated with a post-trial observational follow-up.

METHODS

Between January 2014 and July 2016, 1054 patients were randomly assigned to an initial strategy of receiving either Xinyue capsule or placebo for 24 weeks together with the conventional treatment. Between July and October 2024, we collected clinical outcome data from original trial participants to evaluate long-term effectiveness. The primary endpoint was a composite of cardiac death, non-fatal myocardial infarction, and urgent revascularization, whereas secondary composite endpoint included stroke, rehospitalization due to acute coronary syndrome, and all-cause mortality. The Kaplan-Meier method estimated cumulative event incidences, while multivariable Cox regression calculated hazard ratios (HRs) and 95 % confidence intervals (CIs).

RESULTS

Post-trial follow-up information was available for 887 patients. The median follow-up period was 10 years (interquartile range, 9.4-10.1 years). The primary endpoint occurred in 19.43 % of the Xinyue capsule group compared to 24.24 % in the placebo group (HR: 0.727, 95 % CI: 0.560 - 0.942, p = 0.016). Secondary endpoint occurred in 25.09 % of the Xinyue capsule group and 31.87 % in the placebo group (HR: 0.687, 95 % CI: 0.547 - 0.863, p = 0.0012).

CONCLUSIONS

Early Xinyue capsule intervention in addition to the conventional treatment was associated with a significant reduction in composite cardiovascular endpoint over the subsequent 10 years in patients with stable CAD post-PCI.