颅内动脉狭窄的血管内支架置入与积极药物治疗的比较。
Stenting versus aggressive medical therapy for intracranial arterial stenosis.
机构信息
Department of Neurosciences, Medical University of South Carolina, Charleston, SC 29425, USA.
出版信息
N Engl J Med. 2011 Sep 15;365(11):993-1003. doi: 10.1056/NEJMoa1105335. Epub 2011 Sep 7.
BACKGROUND
Atherosclerotic intracranial arterial stenosis is an important cause of stroke that is increasingly being treated with percutaneous transluminal angioplasty and stenting (PTAS) to prevent recurrent stroke. However, PTAS has not been compared with medical management in a randomized trial.
METHODS
We randomly assigned patients who had a recent transient ischemic attack or stroke attributed to stenosis of 70 to 99% of the diameter of a major intracranial artery to aggressive medical management alone or aggressive medical management plus PTAS with the use of the Wingspan stent system. The primary end point was stroke or death within 30 days after enrollment or after a revascularization procedure for the qualifying lesion during the follow-up period or stroke in the territory of the qualifying artery beyond 30 days.
RESULTS
Enrollment was stopped after 451 patients underwent randomization, because the 30-day rate of stroke or death was 14.7% in the PTAS group (nonfatal stroke, 12.5%; fatal stroke, 2.2%) and 5.8% in the medical-management group (nonfatal stroke, 5.3%; non-stroke-related death, 0.4%) (P=0.002). Beyond 30 days, stroke in the same territory occurred in 13 patients in each group. Currently, the mean duration of follow-up, which is ongoing, is 11.9 months. The probability of the occurrence of a primary end-point event over time differed significantly between the two treatment groups (P=0.009), with 1-year rates of the primary end point of 20.0% in the PTAS group and 12.2% in the medical-management group.
CONCLUSIONS
In patients with intracranial arterial stenosis, aggressive medical management was superior to PTAS with the use of the Wingspan stent system, both because the risk of early stroke after PTAS was high and because the risk of stroke with aggressive medical therapy alone was lower than expected. (Funded by the National Institute of Neurological Disorders and Stroke and others; SAMMPRIS ClinicalTrials.gov number, NCT00576693.).
背景
颅内动脉粥样硬化性狭窄是导致中风的一个重要原因，目前越来越多地采用经皮腔内血管成形术和支架置入术（PTAS）来预防中风复发。然而，PTAS 尚未在随机试验中与药物治疗进行比较。
方法
我们将近期短暂性脑缺血发作或由颅内主要动脉狭窄 70%至 99%引起的中风患者随机分为单纯强化药物治疗组或强化药物治疗加使用 Wingspan 支架系统的 PTAS 组。主要终点为入组后 30 天内或在随访期间对符合条件的病变进行血管再通治疗后 30 天内的中风或死亡，或在 30 天后符合条件的动脉区域内发生中风。
结果
在 451 名患者随机分组后，入组停止，因为 PTAS 组 30 天内的中风或死亡率为 14.7%（非致命性中风 12.5%；致命性中风 2.2%），药物治疗组为 5.8%（非致命性中风 5.3%；非中风相关死亡 0.4%）（P=0.002）。超过 30 天后，两组各有 13 例患者发生同一部位的中风。目前，正在进行的中位随访时间为 11.9 个月。两组间主要终点事件的发生时间存在显著差异（P=0.009），PTAS 组 1 年主要终点发生率为 20.0%，药物治疗组为 12.2%。
结论
在颅内动脉狭窄患者中，强化药物治疗优于使用 Wingspan 支架系统的 PTAS，这是因为 PTAS 后早期中风的风险较高，而且强化药物治疗单独治疗的中风风险低于预期。（由美国国立神经病学和中风研究所等资助；SAMMPRIS ClinicalTrials.gov 编号，NCT00576693）。
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