Zeenat Qureshi Stroke Research Center, Department of Neurology, University of Minnesota, Minneapolis, Minnesota 55455, USA.
J Neuroimaging. 2012 Jan;22(1):1-13. doi: 10.1111/j.1552-6569.2011.00685.x.
The results of prematurely terminated stenting and aggressive medical management for preventing recurrent stroke in intracranial stenosis (SAMMPRIS) due to excessively high rate of stroke and death in patients randomized to intracranial stent placement is expected to affect the practice of endovascular therapy for intracranial atherosclerotic disease. The purpose of this report is to review the components of the designs and methods SAMMPRIS trial and to describe the influence of those components on the interpretation of trial results.
A critical review of the patient population included in SAMMPRIS is conducted with emphasis on "generalizability of results" and "bias due to cherry picking phenomenon." The technical aspects of endovascular treatment protocol consisting of intracranial angioplasty and stent placement using the Gateway balloon and Wingspan self-expanding nitinol stent and credentialing criteria of trial interventionalists are reviewed. The influence of each component is estimated based on previous literature including multicenter clinical trials reporting on intracranial angioplasty and stent placement.
The inclusion criteria used in the trial ensured that patients with adverse clinical or angiographic characteristics were excluded. Self-expanding stent as the sole stent, technique of prestent angioplasty, periprocedural antiplatelet treatment, and intraprocedural anticoagulation are unlikely to adversely influence the results of intracranial stent placement. A more permissive policy toward primary angioplasty as an acceptable treatment option may have reduced the overall periprocedural complication rates by providing a safer option in technically challenging lesions. The expected impact of a more rigorous credentialing process on periprocedural stroke and/or death rate following intracranial stent placement in SAMMPRIS such as the one used in carotid revascularization endarterectomy versus stenting trial remains unknown.
The need for developing new and effective treatments for patients with symptomatic intracranial stenosis cannot be undermined. The data support modification but not discontinuation of our approach to intracranial angioplasty and/or stent placement for intracranial stenosis. There are potential patients in whom angioplasty and/or stent placement might be the best approach, and a new trial with appropriate modifications in patient selection and design may be warranted.
由于颅内狭窄患者接受颅内支架置入术的随机分组后，卒中率和死亡率过高，因此终止了支架置入和强化药物治疗以预防再发卒中的 SAMMPRIS 研究结果，预计会影响颅内动脉粥样硬化性疾病血管内治疗的实践。本报告旨在回顾 SAMMPRIS 试验的设计和方法部分，并描述这些组成部分对试验结果解读的影响。
对 SAMMPRIS 试验纳入的患者人群进行了严格审查，重点关注“结果的普遍性”和“因选择性偏倚造成的偏差”。同时还回顾了血管内治疗方案的技术方面，包括使用 Gateway 球囊和 Wingspan 自膨式镍钛合金支架进行颅内血管成形术和支架置入术，以及试验介入医生的认证标准。根据既往文献，包括关于颅内血管成形术和支架置入术的多中心临床试验报告，评估了每个组成部分的影响。
试验中使用的纳入标准确保了排除了具有不良临床或血管造影特征的患者。自膨式支架作为唯一的支架、支架置入前血管成形术技术、围手术期抗血小板治疗和术中抗凝，不太可能对颅内支架置入的结果产生不利影响。对于原发性血管成形术作为可接受的治疗选择采取更宽松的政策，可能通过为技术挑战性病变提供更安全的选择，从而降低整体围手术期并发症发生率。在 SAMMPRIS 中，颅内支架置入后围手术期卒中率和/或死亡率预期会受到更严格的认证流程的影响，如颈动脉血运重建内膜切除术与支架置入试验中所使用的流程，但目前尚不清楚其确切影响。
不能否定为有症状颅内狭窄患者开发新的有效治疗方法的必要性。数据支持修改但不停止我们对颅内血管成形术和/或支架置入治疗颅内狭窄的方法。对于某些患者，血管成形术和/或支架置入可能是最佳治疗方法，可能需要进行新的试验，并对患者选择和设计进行适当的修改。
