The Feinberg Award Lecture 2013: treatment of intracranial atherosclerosis: learning from the past and planning for the future.
The Feinberg Award Lecture 2013: treatment of intracranial atherosclerosis: learning from the past and planning for the future.
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DOI：
10.1161/strokeaha.113.001290
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发表时间：
2013-09
期刊：
影响因子：
8.3
通讯作者：
Chimowitz MI
中科院分区：
文献类型：
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作者：
Chimowitz MI
Chimowitz治疗颅内动脉粥样硬化2665例患者，如Seemant Chaturvedi和Tanya Turan领导的分析所示。这些分析表明，与未达到这些目标的患者相比，随访期间平均收缩压< 140 mm Hg或平均胆固醇< 200 mg/dL的患者单独卒中和主要血管事件的发生率显著降低。这些数据是随后SAMMPRIS试验中使用的强化风险因素管理方案的基础。当我们设计WASID时，我们充分意识到自Sundt等人20关于基底动脉狭窄血管成形术的原始论文以来，支架技术和介入技术的进步。因此，WASID中预先设定的次要目的是识别狭窄动脉区域卒中高风险的患者，这些患者将成为随后比较血管内治疗与药物治疗的试验（SAMMPRIS）的目标人群。Scott Kasner 8领导了这项工作，研究表明复发性中风最重要的预测因素是狭窄的严重程度。狭窄< 70%的患者1年时卒中发生率为7%-8%，而狭窄≥ 70%的患者1年时卒中发生率为18%。如果在入组后30天内发生符合WASID标准的事件，狭窄度为70%至99%的患者的风险甚至更高（1年时为22.9%）。然而，对于狭窄度为70%至99%的患者，如果其合格事件在入组前> 30天发生，则风险为中等（1年时为9%）。这些数据导致决定将SAMMPRIS的入组限制在狭窄70%至99%的患者中，这些患者的合格事件发生在入组前30天内。Wingspan支架系统是由食品和药物管理局根据人道主义设备豁免批准的，适用于50%至99%根据在欧洲和亚洲进行的45例患者的单组试验，22在临床实践中，使用Wingspan支架的难治性医疗管理适应症主要解释为在接受任何抗血栓治疗时发生与颅内狭窄相关的TIA或卒中。食品药品监督管理局批准Wingspan系统后，在美国进行了两项多中心登记研究（美国多中心登记研究23和NIH Wingspan登记研究）24和亚洲单中心研究25显示了较高的技术成功率（96.7%-98.8%），与狭窄率为70%-99%的WASID患者相比，1年时的卒中率可能更低。需要进行一项随机试验来确定与药物治疗相比，支架植入术是否能降低高风险患者的卒中风险，这将我们带到了SAMMPRIS试验。SAMMPRIS是一项随机试验，在入组前30天内患有70%至99%颅内狭窄和符合条件的TIA或卒中的患者中，比较了Wingspan系统加积极药物管理与单独积极药物管理的支架植入术。26除围手术期外，试验两组的积极医疗管理相同。27氯吡格雷（75 mg/d）与阿司匹林（325 mg/d）合用90天，然后单独服用阿司匹林> 90天。主要风险因素的管理（收缩压
Chimowitz Treatment of Intracranial Atherosclerosis 2665 patients, as shown in analyses that Seemant Chaturvedi and Tanya Turan led. These analyses suggested that patients with a mean systolic blood pressure of< 140 mm Hg or mean cholesterol< 200 mg/dL during follow-up had significantly lower rates of stroke alone as well as major vascular events compared with patients who did not achieve these targets. 18, 19 These data were the basis for the intensive risk factor management protocols used in the subsequent SAMMPRIS trial. When we were designing WASID, we were well aware of the advances in stent technology and interventional techniques that had been made since the original paper of Sundt et al20 on angioplasty for basilar artery stenosis. So the prespecified secondary aim in WASID was to identify patients at high risk of stroke in the territory of the stenotic artery who would be the target population for a subsequent trial comparing endovascular therapy with medical treatment that became SAMMPRIS. Scott Kasner8 led this work, which showed that the most important predictor of recurrent stroke was severity of stenosis. Patients with< 70% stenosis had a stroke in the territory rate of 7% to 8% at 1 year, whereas the rate was 18% at 1 year in patients with≥ 70% stenosis. The risk was even higher in patients with 70% to 99% stenosis if their qualifying event for WASID had occurred within 30 days of enrollment (22.9% at 1 year). However, the risk was modest in patients with 70% to 99% stenosis if their qualifying event had occurred> 30 days before enrollment (9% at 1 year). These data led to the decision to restrict enrollment in SAMMPRIS to patients with 70% to 99% stenosis whose qualifying event occurred within 30 days before enrollment.Just as WASID ended, the Wingspan stent system was approved by the Food and Drug Administration under a humanitarian device exemption for patients with 50% to 99% stenosis who are refractory to medical management21 on the basis of a single arm trial of 45 patients performed in Europe and Asia. 22 In clinical practice, the refractory to medical management indication for use of the Wingspan stent was largely interpreted to mean having a TIA or stroke related to intracranial stenosis while taking any antithrombotic therapy. Two multicenter registries performed in the United States after Food and Drug Administration approval of the Wingspan system (the US Multicenter registry23 and the NIH Wingspan registry) 24 and a single center study in Asia25 showed high technical success rates (96.7%–98.8%) using the self-expanding Wingspan stent and possibly lower stroke rates at 1 year compared with WASID patients with 70% to 99% stenosis. A randomized trial was needed to determine whether stenting lowered the risk of stroke compared with medical therapy in high-risk patients, which brings us to the SAMMPRIS trial. SAMMPRIS is a randomized trial comparing stenting with the Wingspan system plus aggressive medical management versus aggressive medical management alone in patients with 70% to 99% intracranial stenosis and a qualifying TIA or stroke within 30 days before enrollment. 26 With the exception of the peri-procedural period, aggressive medical management is the same in both arms of the trial. 27 Clopidogrel (75 mg/d) is combined with aspirin (325 mg/d) for 90 days, followed by aspirin alone> 90 days. Management of the primary risk factors (systolic blood