Clinical Research On Intracranial And Extracranial Artery Stent Restenosis

Part I:Comparison of endovascular stenting and medical treatment for symptomatic intracranial vertebral artery atherosclerotic stenosisObjective:To compare the long-term efficacy of endovascular stenting versus optimal medical treatment (OMT) for severe symptomatic atherosclerotic intracranial vertebral artery stenosis.Methods:Patients who had symptomatic intracranial vertebral artery atherosclerotic stenosis (≥70%of luminal reduction based on Digital Subtraction Angiography) were retrieved from the Nanjing Stroke Registry Program between March2006and February2012. They were divided into the stenting group and OMT group according to the adopted treatment modality. Demographics, vascular risk factors, perioperative complications, recurrence of cerebrovascular events, death, and recovery of neurological function were compared between the two groups.Results:Of the101enrolled consecutive patients (81men and20females; median age63years [range45-80years],47were assigned to stenting group, and54in OMT group. No statistical difference was found with respect to the baseline data between groups. During a mean followed-up time of23.3months, the combined primary end point events (a combination of any stroke or death within30days and the posterior circulation ischemic stroke after30days) occurred6cases (12.9%) in stents groups,10(18.5%) in simple drug group. There was no statistically difference (P=0.373) between groups in respect to the combined primary end point events. Further analysis showed that the incidence of primary end point events within30days for stenting groups was6.5%, for OMT group was1.85%. The difference was not statistically significant (P=0.095). But the accumulated event rate from the30th day to final follow-up was found significant difference between the two groups (P=0.022,95%CI:0.07-0.81, HR=0.23). At the final follow-up, the rate of patients with good clinical outcome (mRS<2) in stenting group was higher than that of simple drug group (91.5%versus83.3%, P=0.037).Conclusion:In patients with intracranial vertebral artery stenosis, stenting treatment was not superior to medical management, because the risk of early stroke of stenting treatment was relatively high. But the effect of stent treatment in preventing stroke in the territory of qualifying artery was superior to medical treatment beyond30days and helps to improve the neurological outcome. Improvement the perioperative security is critical to improve the long-term outcomes. Part II The clinical study of Butylphthalide for prevention of intracranial and extracranial artery stent restenosis-a pilot study RCTObject:Assess Butylphthalide soft capsules in preventing in-stent restenosis after stenting for moderate to severe atherosclerosis artery stenosis of intracranial and extracranial.Method:A randomized, double-blind, placebo-controlled study was designed.100patients included in this study were randomly assigned into two groups randomly (50cases in each group). Patients were administered with oral Butylphthalide or placebo for6months blindly from the day successful stenting. Clinical follow-up were scheduled at3,6,12months after successful stenting. Cerebral angiography or CTA were reviewed in6-12months after operation. The primary endpoint is defined as the occurrence of in-stent stenosis>50%, or the lumen loss greater than20%in case of a residual stenosis was greater than30%. Secondary endpoint events include ischemia stroke or TIA in the territory of qualified vessels, vascular death, intracranial hemorrhage, myocardial infarction, target vessel revascularization.Result:A total of65patients were followed up for image (60cases reviewed by cerebral angiography,5with CTA). Of the65patients with follow-up, six cases (18.8%) of restenosis were identified in32cases of the Butylphthalide group;9cases (27.3%) of restenosis were found in33cases of the placebo group. The restenosis rate was found no statistical significance between groups (P=0.415). Additionally, the secondary endpoint events was also no significant difference (HR=0.946,95%CI:0.305-2.934, P=0.923). One case of muscle pain with elevated muscle enzymes and1case of cerebral hemorrhage were found in Butylphthalide group within six months.Conclusion:The small sample sizes placebo randomized controlled trials of Butylphthalide can not be effective in preventing intracranial and extracranial stent restenosis...