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巴罗破裂动脉瘤试验中的囊状动脉瘤分析。

Analysis of saccular aneurysms in the Barrow Ruptured Aneurysm Trial.

机构信息

Departments of1Neurosurgery and.

3Department of Neurology, University of California, San Francisco, California.

出版信息

J Neurosurg. 2018 Jan;128(1):120-125. doi: 10.3171/2016.9.JNS161301. Epub 2017 Feb 24.

Abstract

OBJECTIVE The Barrow Ruptured Aneurysm Trial (BRAT) is a prospective, randomized trial in which treatment with clipping was compared to treatment with coil embolization. Patients were randomized to treatment on presentation with any nontraumatic subarachnoid hemorrhage (SAH). Because all other randomized trials comparing these 2 types of treatments have been limited to saccular aneurysms, the authors analyzed the current BRAT data for this subgroup of lesions. METHODS The primary BRAT analysis included all sources of SAH: nonaneurysmal lesions; saccular, blister, fusiform, and dissecting aneurysms; and SAHs from an aneurysm associated with either an arteriovenous malformation or a fistula. In this post hoc review, the outcomes for the subgroup of patients with saccular aneurysms were further analyzed by type of treatment. The extent of aneurysm obliteration was adjudicated by an independent neuroradiologist not involved in treatment. RESULTS Of the 471 patients enrolled in the BRAT, 362 (77%) had an SAH from a saccular aneurysm. Patients with saccular aneurysms were assigned equally to the clipping and the coiling cohorts (181 each). In each cohort, 3 patients died before treatment and 178 were treated. Of the 178 clip-assigned patients with saccular aneurysms, 1 (1%) was crossed over to coiling, and 64 (36%) of the 178 coil-assigned patients were crossed over to clipping. There was no statistically significant difference in poor outcome (modified Rankin Scale score > 2) between these 2 treatment arms at any recorded time point during 6 years of follow-up. After the initial hospitalization, 1 of 241 (0.4%) clipped saccular aneurysms and 21 of 115 (18%) coiled saccular aneurysms required retreatment (p < 0.001). At the 6-year follow-up, 95% (95/100) of the clipped aneurysms were completely obliterated, compared with 40% (16/40) of the coiled aneurysms (p < 0.001). There was no difference in morbidity between the 2 treatment groups (p = 0.10). CONCLUSIONS In the subgroup of patients with saccular aneurysms enrolled in the BRAT, there was no significant difference between modified Rankin Scale outcomes at any follow-up time in patients with saccular aneurysms assigned to clipping compared with those assigned to coiling (intent-to-treat analysis). At the 6-year follow-up evaluation, rates of retreatment and complete aneurysm obliteration significantly favored patients who underwent clipping compared with those who underwent coiling. Clinical trial registration no.: NCT01593267 (clinicaltrials.gov).

摘要

目的

巴罗破裂动脉瘤试验(BRAT)是一项前瞻性、随机试验,比较了夹闭治疗与线圈栓塞治疗。患者在出现任何非创伤性蛛网膜下腔出血(SAH)时随机接受治疗。由于所有其他比较这两种治疗方法的随机试验都仅限于囊状动脉瘤,因此作者分析了当前 BRAT 数据中这组病变的情况。

方法

BRAT 的主要分析包括所有来源的 SAH:非动脉瘤性病变;囊状、疱状、梭形和夹层动脉瘤;以及与动静脉畸形或瘘管相关的动脉瘤引起的 SAH。在本事后分析中,进一步按治疗类型分析了囊状动脉瘤亚组患者的结局。由未参与治疗的独立神经放射学家裁定动脉瘤闭塞程度。

结果

在 BRAT 中纳入的 471 名患者中,362 名(77%)有囊状动脉瘤引起的 SAH。囊状动脉瘤患者平均分配至夹闭组和线圈组(各 181 名)。在每个队列中,3 名患者在治疗前死亡,178 名患者接受了治疗。在夹闭组的 178 名囊状动脉瘤患者中,1 名(1%)交叉至线圈组,64 名(36%)线圈组的患者交叉至夹闭组。在 6 年的随访期间,任何记录的时间点,这两种治疗组之间不良结局(改良 Rankin 量表评分>2)均无统计学显著差异。在最初的住院治疗后,241 名夹闭囊状动脉瘤患者中有 1 名(1%)和 115 名接受线圈栓塞的囊状动脉瘤患者中有 21 名(18%)需要再次治疗(p<0.001)。在 6 年随访时,95%(95/100)夹闭的动脉瘤完全闭塞,而 40%(16/40)线圈组的动脉瘤闭塞(p<0.001)。两组之间的发病率无差异(p=0.10)。

结论

在 BRAT 中纳入的囊状动脉瘤患者亚组中,在接受夹闭治疗与接受线圈栓塞治疗的囊状动脉瘤患者之间,在任何随访时间的改良 Rankin 量表结局方面均无显著差异(意向治疗分析)。在 6 年随访评估时,再次治疗和完全闭塞动脉瘤的比率明显有利于接受夹闭治疗的患者,而不是接受线圈栓塞的患者。

临床试验注册编号

NCT01593267(clinicaltrials.gov)。

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