Mohr J P, Overbey Jessica R, von Kummer Ruediger, Stefani Marco A, Libman Richard, Stapf Christian, Parides Michael K, Pile-Spellman John, Moquete Ellen, Moy Claudia S, Vicaut Eric, Moskowitz Alan J, Harkness Kirsty, Cordonnier Charlotte, Biondi Alessandra, Houdart Emmanuel, Berkefeld Joachim, Klijn Catharina J M, Barreau Xavier, Kim Helen, Hartmann Andreas
From Columbia University Medical Center (J.P.M.); Icahn School of Medicine at Mount Sinai (J.R.O., M.K.P., E.M., A.J.M.), New York, NY; University Hospital Dresden (R.v.K.), Germany; Federal University of Rio Grande do Sul (M.A.S.), Porto Alegre, Brazil; North Shore-Long Island Jewish Medical Center (R.L.), New York, NY; University of Montreal (C.S.), Quebec, Canada; Winthrop University Hospital (J.P.-S.), Mineola, NY; National Institute of Neurological Disorders and Stroke (C.S.M.), NIH, Bethesda, MD; Hôpital Lariboisière (E.V., E.H.), Paris, France; Royal Hallamshire Hospital (K.H.), Sheffield, UK; Université Lille Nord de France (C.C.); University of Franche Comté (A.B), Besançon, France; Universitätsklinikum Frankfurt am Main (J.B.), Germany; Department of Neurology (C.J.M.K.), Donders Institute for Brain, Cognition and Behaviour, Center for Neuroscience, Radboud University Medical Center, Nijmegen, and Department of Neurology and Neurosurgery (C.J.M.K.), Brain Center Rudolf Magnus, University Medical Center, Utrecht, the Netherlands; CHU Pellegrin (X.B.), Bordeaux, France; University of California (H.K.), San Francisco; and Department of Neurology (A.H.), Klinikum Frankfurt (Oder), Germany.
Neurology. 2017 Oct 3;89(14):1499-1506. doi: 10.1212/WNL.0000000000004532. Epub 2017 Sep 6.
OBJECTIVE: To investigate the effects of medical vs interventional management on functional outcome in A Randomized Trial of Unruptured Brain Arteriovenous Malformations (ARUBA). METHODS: We used the initial results of a nonblinded, randomized, controlled, parallel-group trial involving adults ≥18 years of age with an unruptured brain arteriovenous malformation (AVM) to compare the effects of medical management (MM) with or without interventional therapy (IT) on functional impairment, defined by a primary outcome of death or symptomatic stroke causing modified Rankin Scale (mRS) score ≥2. ARUBA closed recruitment on April 15, 2013. RESULTS: After a median of 33.3 months of follow-up (interquartile range 16.3-49.8 months), of the 223 enrolled in the trial, those in the MM arm were less likely to experience primary outcomes with an mRS score ≥2 than those who underwent IT. The results applied for both those as randomized (MM n = 109 vs IT n = 114) (hazard ratio [HR] 0.25, 95% confidence interval [CI] 0.11-0.57, = 0.001) and as treated (MM n = 125 vs IT n = 98) (HR 0.10, 95% CI 0.04-0.28, < 0.001). Functional impairment for the outcomes showed no significant difference by Spetzler-Martin grade for MM but was more frequent with increasing grades for IT ( < 0.001). CONCLUSION: Death or stroke with functional impairment in ARUBA after a median follow-up of 33 months was significantly lower for those in the MM arm both as randomized and as treated compared with those with IT. Functional severity of outcomes was lower in the MM arm, regardless of Spetzler-Martin grades. CLINICALTRIALSGOV IDENTIFIER: NCT00389181. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that for adults with unruptured brain AVMs, interventional management compared to MM increases the risk of disability and death over ≈3 years.
目的：在未破裂脑动静脉畸形随机试验（ARUBA）中，研究药物治疗与介入治疗对功能结局的影响。 方法：我们采用了一项非盲、随机、对照、平行组试验的初始结果，该试验纳入了年龄≥18岁的未破裂脑动静脉畸形（AVM）成人患者，以比较药物治疗（MM）联合或不联合介入治疗（IT）对功能损害的影响，功能损害的主要结局定义为死亡或导致改良Rankin量表（mRS）评分≥2的症状性卒中。ARUBA于2013年4月15日结束招募。 结果：在中位随访33.3个月（四分位间距16.3 - 49.8个月）后，在试验纳入的223例患者中，MM组发生mRS评分≥2的主要结局的可能性低于接受IT治疗的患者。该结果适用于随机分组的患者（MM组n = 109 vs IT组n = 114）（风险比[HR] 0.25，95%置信区间[CI] 0.11 - 0.57，P = 0.001）以及接受治疗的患者（MM组n = 125 vs IT组n = 98）（HR 0.10，95% CI 0.04 - 0.28，P < 0.001）。MM组结局的功能损害在Spetzler - Martin分级方面无显著差异，但IT组随着分级增加更常见（P < 0.001）。 结论：在ARUBA中，中位随访33个月后，MM组随机分组和接受治疗的患者发生伴有功能损害的死亡或卒中的情况均显著低于接受IT治疗的患者。无论Spetzler - Martin分级如何，MM组结局的功能严重程度均较低。 临床试验注册号：NCT00389181。 证据分类：本研究提供了II类证据，即对于患有未破裂脑AVM的成年人，与MM相比，介入治疗在约3年时间内增加了残疾和死亡风险。
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