李天晓与李钊硕等(2010). "Wingspan支架治疗症状性颅内动脉粥样硬化严重狭窄的临床研究." 中华放射学杂志 44(9): 969-974.
目的 研究Wingspan支架成形术治疗症状性颅内动脉狭窄的安全性、可行性和中短期疗效.方法 113例症状性、颅内动脉粥样硬化性严重狭窄患者接受了Wingspan支架成形术,统计分析了手术成功率、手术前后狭窄程度变化、围手术期并发症、复诊临床疗效及再狭窄率,并通过χ2检验分析并发症发生率,与治疗该疾病的2项国际研究[药物疗效研究(WASID)和美国国立卫生研究院(NIH)多中心 Wingspan支架疗效研究]结果进行对比.结果 手术成功率为99.1%(112/113),血管狭窄程度由术前的(80.7±9.3)%降至术后的(27.7±9.7)%(χ2=9.397,P<0.05);随访1.0～28.0个月,平均随访14.5个月,总并发症率为4.4%(5/113),术后6个月再狭窄率为12.5%(5/40).WASID研究的终点事件、缺血性卒中率、病变区域缺血性卒中率分别为21.1%、20.4%、15.0%,该研究分别为4.5%、3.5%、3.5%,差异有统计学意义(P<0.05);在WASID研究认为药物控制不良的狭窄程度≥70%、末次事件距治疗时间≤17 d和NIH神经功能缺损评分(NIHSS)>1分3个亚组卒中率分别为19.0%、17.0%和19.6%,该组分别为4.5%、4.7%和2.0%,表明支架成形疗效优于WASID研究中的药物治疗疗效(P<0.05).与NIH研究结果(14.0%)相比,该组中期疗效(4.5%)明显提高(P<0.05).结论 Wingspan支架治疗症状性颅内动脉严重狭窄具有良好的安全性和可行性,围手术期内总的卒中率较低.主要终点事件、缺血性卒中事件的发生率低于药物治疗组;对于高危人群,支架成形术的疗效也明显优于药物.
Objective To assess the safety, feasibility, short-and mid-term efficacy of wingspan stent for treating patients with symptomatic intracranial artery stenosis. Methods A total of 113 patients with severe symptomatic intracranial stenosis were enrolled and Gateway-wingspan stenting were performed on all patients. The technical success, the pre- and post-stenting stenosis, perioperative complications, clinical outcome and restenosis rates were recorded, and chi-square test was used for analysis of complication rate by comparing our results with the results of Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) study and NIH multi-center Wingspan stenting trial. Results The technical success rate was 99. 1% ( 112/113). The mean pre and post-stent stenoses were (80.7 ± 9.3)% and (27.7 ± 9.7)% (χ2 =9.397,P < 0. 05 ). The total complication rate was 4.4% (5/113 ) during the follow-up ( mean 14. 5 months, range 1-28 months), and the frequency of restenosis was 12. 5% (5/40) at 6 months. The primary endpoint events, ischemic stroke, and lesion-related ischemic stroke were lower in our study (4.5%, 3.5%,3.5% ) compared with the results of WASID trial (21.1%, 20. 4%, 15.0% ,P<0. 05). For those with poor outcome in the three high-risk sub-groups which were with more than 70% stenosis, or last event from the treatment was less than 17 days, or NIHSS was above 1, a better outcome was observed in our group (4. 5% ,4. 7% and 2. 0% in our study, 19.0%, 17.0% and 19. 6% in previous study, P < 0. 05). The medium-term efficacy in this group (4. 5% ) significantly improved compared with NIH study ( 14. 0% ,P <0. 05 ). Conclusions Wingspan stenting for symptomatic intracranial arterial stenosis is with good safety,feasibility and low perioperative stroke rate and mortality. The incidence of primary endpoint events and the ischemic events are lower than those of medication group, and the efficacy of stenting is significantly better than medication even in high-risk population.