The Short-term Safety Of Dan Qi Pian Tan Formula Plus Stenting For Atherosclerotic Ischemic Cerebrovascular Disease

BACKGROUND & PURPOS: Endovascular stenting have been becoming an effective therapeutic method to prevent development or recurrence of ischemic stroke.In clinical,Dan Qi Pian Tan formula have demonstrated positive effect in such aspects as improving the prognosis of ischemic stroke.Up to now,the perioperative safety and validity of traditional Chinese medicine(TCM)is lack of evidence supported by medicine,when TCM was applied to stenting of ischemic cerebrovascular disease.This study aims to survey effect of Dan Qi Pian Tan formula in reducing adverse vascular events after stenting,by means of combining stenting.METOD: Patients enrolled in the study were divided into intervention group(control group)and TCM + intervention group(treatment group).Patients who have developed cerebral infarction,TIA or in high risk of cerebral infarction caused by atherosclerosis related cerebrovascular stenosis which confirmed by CTA,MRA or TCD have to meet the criterion of “Ischemic Stroke Syndrome Complex Factor Scale”.Stenting were operated in all patients,while stenting for acute ischemic stroke patients was performed 3 weeks after onset.Once enrolled,Dan Qi Pian Tan formula was taken by treatment group patients,which the course is 30 days.Follow-up of 90 days,the primary outcome is 90 days adverse events of target vessel,including recurrence of symptomatic ischemic stroke in target vessel region,symptomatic hemorrhage,stroke-related mortality and in-stent restenosis.The results were analyzed with chi-square test,P value<0.05 has statistical significance.The primary outcome have no statistical difference between groups(P = 0.57).One symptomatic ischemic stroke in target vessel region(2.7%v.s.2.9%)developed respectively,in each group.1(2.7%)patient had symptoms cerebral hemorrhage post-procedural in treatment group.In follow-up,2 cases developed vertebral artery original in-stent restenosis,which stenosis degree is 50%,90%,respectively(P=0.04).Any cerebral infarct in two groups within 90 days occurred 8(11.3%)cases,including target vessel infarction,2(2.8%)cases,other vascular infarction,6(8.5%)and have no statistical significance between groups(P = 0.67).Modified Rankin score,NIHSS and Barthel index(BI)have no statistical significance(P values were 0.53,0.53,0.11,respectively),pre-and post-intervention.RESULTS:CONCLUSION: Dan Qi Pian Tan formula can be applied to atherosclerosis ischemic cerebrovascular disease patients with stent.It may play a positive role in reducing short-term adverse events peri-intervention,especially the prevention for vertebral artery in-stent restenosis.