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对于未破裂的大脑动脉静脉形形 (ARUBA) 的干预治疗或没有干预治疗的医疗管理:多中心,非盲目的随机试验

J P Mohr¹, Michael K Parides², Christian Stapf³

¹The Neurological Institute, Columbia University Medical Center, New York, NY, USA.

Lancet (London, England)

|November 26, 2013

概括

对于未破裂的大脑动脉静脉形形,仅仅通过医疗管理就能显著降低与干预治疗相比,死亡或中风的风险. 这项研究发现干预疗法导致这些疾病患者的治疗结果更差.

科学领域:

神经学神经学
神经外科神经外科
血管医学血管医学

背景情况:

积极治疗未破裂的大脑动脉静脉形 (bAVMs) 的临床有效性尚未得到充分证实.
亚鲁巴 (A Randomized trial of Unruptured Brain Arteriovenous malformations) 试验旨在评估与干预相比保守管理相关的风险.

研究的目的:

在未破裂的bAVMs患者中,单独进行医疗管理和联合医疗/干预治疗之间的死亡和症状性中风风险进行比较.
评估不同治疗策略的安全性和有效性,对未破裂的bAVMs.

主要方法:

没有破裂的bAVM的成年患者被随机分组1:1接受干预治疗 (神经外科,栓塞,放射治疗) 或单独接受医疗管理的医疗管理.
主要结局是死亡或症状性中风的复合终点,使用治疗意图方法进行分析.
该试验涉及9个国家的39个临床场所,患者,临床医生和研究人员都没有保持失明.

主要成果:

由于医疗管理的优越性,试验被提前停止.
与接受干预治疗的患者相比,仅接受医学治疗的患者的死亡或中风风险显著降低 (HR 0.27,95% CI 0.14-0.54).
干预治疗与中风和与中风无关的神经系统缺陷的更高发病率有关.

结论:

单独的医疗管理优于医疗和干预疗法的联合治疗,以预防未破裂的bAVMs患者的死亡或中风.
这些发现表明,对于未破裂的bAVM,治疗范式的转变,优先考虑保守的管理.
目前正在进行长期跟踪,以确定这些结果差异是否持续存在.

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