血流导向装置治疗颅内动脉瘤：一项实用随机对照护理试验。
Flow Diversion in the Treatment of Intracranial Aneurysms: A Pragmatic Randomized Care Trial.
机构信息
From the Department of Radiology (J.R., D.I., W.B., J.D.B.D., R.K., A.W., D.R.), Centre Hospitalier de l'Université de Montréal, Quebec, Canada
From the Department of Radiology (J.R., D.I., W.B., J.D.B.D., R.K., A.W., D.R.), Centre Hospitalier de l'Université de Montréal, Quebec, Canada.
出版信息
AJNR Am J Neuroradiol. 2022 Sep;43(9):1244-1251. doi: 10.3174/ajnr.A7597. Epub 2022 Aug 4.
BACKGROUND AND PURPOSE
Flow diversion is a recent endovascular treatment for intracranial aneurysms. We compared the safety and efficacy of flow diversion with the alternative standard management options.
MATERIALS AND METHODS
A parallel group, prerandomized, controlled, open-label pragmatic trial was conducted in 3 Canadian centers. The trial included all patients considered for flow diversion. A Web-based platform 1:1 randomly allocated patients to flow diversion or 1 of 4 alternative standard management options (coiling with/without stent placement, parent vessel occlusion, surgical clipping, or observation) as prespecified by clinical judgment. Patients ineligible for alternative standard management options were treated with flow diversion in a registry. The primary safety outcome was death or dependency (mRS > 2) at 3 months. The composite primary efficacy outcome included the core lab-determined angiographic presence of a residual aneurysm, aneurysm rupture, progressive mass effect during follow-up, or death or dependency (mRS > 2) at 3-12 months.
RESULTS
Between May 2011 and November 2020, three hundred twenty-three patients were recruited: Two hundred seventy-eight patients (86%) had treatment randomly allocated (139 to flow diversion and 139 to alternative standard management options), and 45 (14%) received flow diversion in the registry. Patients in the randomized trial frequently had unruptured (83%), large (52% ≥10 mm) carotid (64%) aneurysms. Death or dependency at 3 months occurred in 16/138 patients who underwent flow diversion and 12/137 patients receiving alternative standard management options (relative risk, 1.33; 95% CI, 0.65-2.69; = .439). A poor primary efficacy outcome was found in 30.9% (43/139) with flow diversion and 45.6% (62/136) of patients receiving alternative standard management options, with an absolute risk difference of 14.7% (95% CI, 3.3%-26.0%; relative risk, 0.68; 95% CI, 0.50-0.92; = .014).
CONCLUSIONS
For patients with mostly unruptured, large, anterior circulation (carotid) aneurysms, flow diversion was more effective than the alternative standard management option in terms of angiographic outcome.
背景与目的
血流导向装置是一种治疗颅内动脉瘤的新兴血管内治疗方法。我们比较了血流导向装置与其他替代标准治疗方法的安全性和疗效。
材料与方法
这是一项在加拿大 3 个中心开展的平行分组、预随机、对照、开放标签实用临床试验。该试验纳入了所有考虑采用血流导向装置治疗的患者。通过网络平台，按照临床判断将患者 1:1 随机分配至血流导向装置组或 4 种替代标准治疗方法（单纯弹簧圈栓塞术、支架辅助弹簧圈栓塞术、载瘤动脉闭塞术、手术夹闭术或观察）。不适合采用替代标准治疗方法的患者则在登记处接受血流导向装置治疗。主要安全性结局为 3 个月时的死亡或依赖（改良 Rankin 量表[mRS]评分>2）。复合主要疗效结局包括核心实验室评估的残留动脉瘤、动脉瘤破裂、随访期间进行性占位效应、或 3-12 个月时的死亡或依赖（mRS 评分>2）。
结果
2011 年 5 月至 2020 年 11 月，共纳入 323 例患者：278 例（86%）患者的治疗方案经随机分配（血流导向装置组 139 例，替代标准治疗方法组 139 例），45 例（14%）患者在登记处接受血流导向装置治疗。随机试验患者多为未破裂（83%）、大型（52%≥10 mm）颈内动脉（64%）动脉瘤。接受血流导向装置治疗的 138 例患者中，有 16 例（16/138）和接受替代标准治疗方法的 137 例患者（12/137）发生 3 个月时的死亡或依赖（相对风险，1.33；95%置信区间，0.65-2.69；P=0.439）。接受血流导向装置治疗的 139 例患者中，有 43 例（30.9%）和接受替代标准治疗方法的 136 例患者（45.6%）的主要疗效结局较差，绝对风险差异为 14.7%（95%置信区间，3.3%-26.0%；相对风险，0.68；95%置信区间，0.50-0.92；P=0.014）。
结论
对于大多数未破裂、大型、前循环（颈内动脉）动脉瘤患者，血流导向装置在血管造影结局方面优于替代标准治疗方法。
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