Efficacy and safety of Xuesaitong soft capsule plus antiplatelet agents in ischemic stroke patients: a large-scale, multicenter, controlled, retrospective real-world study.

BACKGROUND

Previous experimental studies have suggested synergistic effects of Panax notoginseng saponins combined with antiplatelet agents in ischemic stroke. However, large-scale real-world clinical evidence regarding the efficacy and safety of this combination remains limited. This study aimed to explore the efficacy and safety of Xuesaitong soft capsule plus antiplatelet agents in ischemic stroke patients.

METHODS

This multicenter, controlled, retrospective real-world study included 38,652 patients with ischemic stroke who received either antiplatelet agents (aspirin and/or clopidogrel) alone (control group, N = 37,249) or Xuesaitong soft capsule plus antiplatelet agents (observational group, N = 1,403). Propensity score matching (PSM) was initially performed at a 1:20 ratio (N = 1,401 in the observational group vs. N = 27,955 in the control group). A 1:4 PSM sensitivity analysis was subsequently performed to evaluate the robustness of the findings (N = 1,401 in the observational group vs. N = 5,604 in the control group).

RESULTS

After 1:20 matching, the 1-year major adverse cardiovascular and cerebrovascular event (MACCE) incidence was lower in the observational group than in the control group (14.99% vs. 18.71%) (P < 0.001). The 2- and 3-year MACCE incidences showed the same trend (both P < 0.001). Subgroup analyses indicated that the reduction in 1-year MACCE incidence was greater in patients aged 45-64 years, treated within 2 weeks after stroke onset, with MACCE occurring within 1 month after treatment, and without hypertension, hyperlipidemia, or coronary heart disease (all P < 0.05). The incidence of adverse events of special interest was lower in the observational group than in the control group (18.56% vs. 21.82%) (P = 0.004). The 1:4 PSM sensitivity analysis confirmed the robustness of the findings, with lower 1-year MACCE incidence in the observational group than in the control group (14.99% vs. 18.58%) (P = 0.002).

CONCLUSION

Xuesaitong soft capsule combined with antiplatelet agents is associated with lower MACCE incidence and gastrointestinal adverse events compared to antiplatelet agents alone in ischemic stroke patients.