Stenting versus aggressive medical therapy for intracranial arterial stenosis.
Stenting versus aggressive medical therapy for intracranial arterial stenosis.
复制标题
DOI：
10.1056/nejmoa1105335
复制
发表时间：
2011-09-15
期刊：
影响因子：
--
通讯作者：
SAMMPRIS Trial Investigators
中科院分区：
文献类型：
--
作者：
Chimowitz MI;Lynn MJ;Derdeyn CP;Turan TN;Fiorella D;Lane BF;Janis LS;Lutsep HL;Barnwell SL;Waters MF;Hoh BL;Hourihane JM;Levy EI;Alexandrov AV;Harrigan MR;Chiu D;Klucznik RP;Clark JM;McDougall CG;Johnson MD;Pride GL Jr;Torbey MT;Zaidat OO;Rumboldt Z;Cloft HJ;SAMMPRIS Trial Investigators
动脉粥样硬化性颅内动脉狭窄是中风的一个重要原因，越来越多地采用经皮腔内血管成形术和支架置入术（PTAS）进行治疗，以预防中风复发。然而，尚未在随机试验中将 PTAS 与医疗管理进行比较。我们将最近因颅内主要动脉直径狭窄 70% 至 99% 而发生短暂性脑缺血发作或中风的患者随机分配至单独积极的医疗治疗组或积极的医疗治疗组加上使用 Wingspan 支架系统的 PTAS。主要终点是入组后 30 天内或在随访期间对合格病变进行血运重建手术后发生中风或死亡，或超过 30 天在合格动脉区域发生中风。 451 名患者接受随机分组后停止入组，因为 PTAS 组的 30 天卒中或死亡率为 14.7%（非致命性卒中，12.5%；致命性卒中，2.2%），而药物治疗组为 5.8%（非致命性卒中，5.3%；非卒中相关死亡，0.4%）（P = 0.002）。超过30天后，每组有13名患者在同一区域发生中风。目前，正在进行的随访的平均持续时间为 11.9 个月。随着时间的推移，两个治疗组之间主要终点事件发生的概率存在显着差异（P = 0.009），PTAS 组主要终点事件的 1 年发生率为 20.0%，而药物治疗组为 12.2%。在颅内动脉狭窄患者中，积极的药物治疗优于使用 Wingspan 支架系统的 PTAS，这既是因为 PTAS 后早期卒中的风险较高，也因为单独采用积极药物治疗的卒中风险低于预期。 （由国家神经疾病和中风研究所等资助；SAMMPRIS ClinicalTrials.gov 编号，NCT00576693。）
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. 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. 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. 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.)