Objective: To further evaluate the effect of Xiongshao Capsule (XSC) on the restenosis (RS) after percutaneous coronary intervention (PCI), based on previous clinical trials by which the preventive effect of XSC on RS after PCI has been proved.
Methods: Adopting the randomized, double-blind and placebo controlled method, the 124 patients enrolled, who were patients with coronary artery disease and received intracoronary stenting, were randomly assigned into two groups, the XSC group and the placebo control group, with 62 in each group. Six months of follow-up study was carried out on them to observe the intervention effect of XSC, which was predominantly evaluated by RS rate estimated by coronary angiography (CAG), combined with the recurrent rate of angina, clinical end-point event, and blood-stasis syndrome scores.
Results: Sixty two cases of 118 effective patients were followed-up with CAG for 6 months, the follow-up rate was 52.5%. The incidence of RS in the XSC group and the control group was 24.1% and 48.5% respectively, and the incidence of RS in stent in them was 14.0% and 42.0% respectively, indicating that the incidence of RS rate in the XSC group was significantly lower than that in the control group (P < 0.05). After patients had been treated for 6 months the extent of angiostenosis and diameter of the culprit arteries, determined by CAG was 26.58 +/- 20.72% and 2.21 +/- 0.85 mm in the XSC group, and 41.19 +/- 30.92% and 1.72 +/- 0.99 mm in the control group, respectively, suggesting that the extent of angiostenosis and the diameter loss were significantly reduced in the former than those in the latter, respectively (P < 0.05). The incidence of clinical end-point event was 11.7% and 27.6% in the XSC group and the control group in the 6 months' follow-up period respectively, it was significantly lower in the XSC group than that in the control group, with the P value close to statistical significance (P = 0.051). The blood-stasis syndrome scores in the XSC group was significantly lower in comparing with that in the control group after 6 months' treatment (P < 0.01).
Conclusion: XSC can effectively prevent RS after PCI in combination with conventional Western medical treatment.