Department of Radiology, Service of Neuroradiology, Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, Quebec, Canada; Department of Interventional Neuroradiology, Fondation Adolphe de Rothschild, Paris, France.
Division of Neurosurgery, Department of Surgery, University of Alberta Hospital, Mackenzie Health Sciences Centre, Edmonton, Alberta, Canada.
World Neurosurg. 2024 May;185:e700-e712. doi: 10.1016/j.wneu.2024.02.114. Epub 2024 Feb 26.
Parent vessel occlusion (PVO) is a time-honored treatment for unclippable or uncoilable intracranial aneurysms. Flow diversion (FD) is a recent endovascular alternative that can occlude the aneurysm and spare the parent blood vessel. Our aim was to compare outcomes of FD with endovascular PVO.
This is a prespecified treatment subgroup analysis of the Flow diversion in Intracranial Aneurysms trial (FIAT). FIAT was an investigator-led parallel-group all-inclusive pragmatic randomized trial. For each patient, clinicians had to prespecify an alternative management option to FD before stratified randomization. We report all patients for whom PVO was selected as the best alternative treatment to FD. The primary outcome was a composite of core-lab determined angiographic occlusion or near-occlusion at 3-12 months combined with an independent clinical outcome (mRS<3). Primary analyses were intent-to-treat. There was no blinding.
There were 45 patients (16.2% of the 278 FIAT patients randomized between 2011 and 2020 in 3 centers): 22 were randomly allocated to FD and 23 to PVO. Aneurysms were mainly large or giant (mean 22 mm) anterior circulation (mainly carotid) aneurysms. A poor primary outcome was reached in 11/22 FD (50.0%) compared to 9/23 PVO patients (39.1%) (RR: 1.28, 95% CI [0.66-2.47]; P = 0.466). Morbidity (mRS >2) at 1 year occurred in 4/22 FD and 6/23 PVO patients. Angiographic results and serious adverse events were similar.
The comparison between PVO and FD was inconclusive. More randomized trials are needed to better determine the role of FD in large aneurysms eligible for PVO.
载瘤动脉闭塞(PVO)是治疗不可夹闭或不可解脱的颅内动脉瘤的传统方法。血流导向装置(FD)是一种最近的血管内替代方法,可闭塞动脉瘤并保留载瘤血管。我们的目的是比较 FD 与血管内 PVO 的治疗结果。
这是血流导向装置在颅内动脉瘤试验(FIAT)的预先指定治疗亚组分析。FIAT 是一项由研究者主导的平行组全包容实用随机试验。对于每个患者,在分层随机分组之前,临床医生必须预先指定 FD 的替代管理选择。我们报告所有选择 PVO 作为 FD 最佳替代治疗的患者。主要结局是由核心实验室确定的 3-12 个月时的血管造影闭塞或接近闭塞与独立临床结局(mRS<3)的组合。主要分析为意向治疗。没有设盲。
共有 45 例患者(278 例 FIAT 患者中随机分组的 16.2%,于 2011 年至 2020 年在 3 个中心进行):22 例随机分配至 FD 组,23 例分配至 PVO 组。动脉瘤主要为大型或巨大(平均 22mm)前循环(主要为颈内动脉)动脉瘤。22 例 FD 患者中有 11 例(50.0%)达到不良的主要结局,而 23 例 PVO 患者中有 9 例(39.1%)(RR:1.28,95%CI [0.66-2.47];P=0.466)。FD 组 1 年内发生 4 例(18.2%)和 PVO 组 6 例(26.1%)患者的并发症(mRS>2)。血管造影结果和严重不良事件相似。
PVO 与 FD 之间的比较尚无定论。需要更多的随机试验来更好地确定 FD 在适合 PVO 的大型动脉瘤中的作用。