Tim E Darsaut, Nicolas Lecaros, Pierre-Olivier Comby, Roland Jabre, Daniela Iancu, Daniel Roy, Alain Weill, Michel W Bojanowski, Chiraz Chaalala, Gilles El Hage, Alain Bilocq, Eric Truffer, J Max Findlay, Jeremy L Rempel, Michael M C Chow, Cian J O'Kelly, Robert A Ashforth, Owen Stechishin, Thomas Gaberel, Charlotte Barbier, Fuat Arikan, Ignacio Arrese, Rosario Sarabia, David J Altschul, Miguel Chagnon, Justine Zehr, Jai J S Shankar, François Proust, Guylaine Gevry, Jean Raymond
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The primary endpoint was death or dependency according to the modified Rankin Scale score (mRS score > 2) at 1 year. Secondary endpoints included 1-year angiographic results and length of hospital stay. The primary hypothesis was that endovascular management would decrease the number of poor outcomes (mRS score > 2) from 30% to 23%, necessitating 1896 patients. The trial was interrupted after 10 years because of slow recruitment. Primary analysis was by intent-to-treat. There was no blinding.</p><p><strong>Results: </strong>From November 2012 to December 2022, 270 patients were recruited at 6 North American and European centers. After exclusions, 263 patients were randomly allocated to receive surgery (n = 133) or EVT (n = 130). There were 12 crossovers (9 from surgery to EVT). The primary outcome was reached in 40 of 133 surgical patients (30%, 95% CI 23%-38%) compared with 35 of 130 EVT patients (27%, 95% CI 20%-35%) (p = 0.572). Residual aneurysms at 1 year were less frequent with surgery (10/118 [8%, 95% CI 5%-15%]) than EVT (22/109 [20%, 95% CI 14%-29%]) (p = 0.015). Additional procedures (ventricular drainage and decompressive craniotomy, p < 0.05) and hospitalization > 20 days were more frequent in the surgery group (69/133 [52%, 95% CI 43%-60%]) than in the EVT group (38/130 [29%, 95% CI 22%-38%]) (p < 0.001).</p><p><strong>Conclusions: </strong>This prematurely interrupted trial showed more frequent additional procedures and longer hospitalizations but better 1-year angiographic results with surgery. 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Residual aneurysms at 1 year were less frequent with surgery (10/118 [8%, 95% CI 5%-15%]) than EVT (22/109 [20%, 95% CI 14%-29%]) (p = 0.015). Additional procedures (ventricular drainage and decompressive craniotomy, p < 0.05) and hospitalization > 20 days were more frequent in the surgery group (69/133 [52%, 95% CI 43%-60%]) than in the EVT group (38/130 [29%, 95% CI 22%-38%]) (p < 0.001).</p><p><strong>Conclusions: </strong>This prematurely interrupted trial showed more frequent additional procedures and longer hospitalizations but better 1-year angiographic results with surgery. 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引用次数: 0
摘要
目的：许多颅内动脉瘤破裂（RIAs）患者未被充分代表或被排除在先前比较手术与血管内治疗（EVT）的随机对照试验（rct）中，但仍考虑手术夹持，但这些患者的最佳治疗方法尚不清楚。方法：国际蛛网膜下腔动脉瘤试验-2是一项比较手术与EVT的随机试验，尽管之前的随机对照试验结果，但考虑手术夹闭的RIAs也符合EVT的条件。根据修改的Rankin量表评分（mRS评分bb0.2），主要终点是1年时的死亡或依赖。次要终点包括1年血管造影结果和住院时间。我们的主要假设是，血管内治疗可以将不良预后（mRS评分bb0.2）的数量从30%减少到23%，需要1896例患者。由于招募缓慢，试验在10年后中断。主要分析是意向治疗。没有致盲。结果：从2012年11月到2022年12月，在北美和欧洲的6个中心招募了270名患者。排除后，263例患者随机分配接受手术（n = 133）或EVT （n = 130）。有12个交叉（9个从手术到EVT）。133例手术患者中有40例达到主要结局（30%,95% CI 23%-38%）， 130例EVT患者中有35例达到主要结局（27%,95% CI 20%-35%） （p = 0.572）。术后1年残留动脉瘤发生率（10/118 [8%,95% CI 5%-15%]）低于EVT (22/109 [20%, 95% CI 14%-29%]) （p = 0.015）。手术组（69/133 [52%,95% CI 43%-60%]）比EVT组（38/130 [29%,95% CI 22%-38%]） （p < 0.001）更频繁地进行额外手术（脑室引流和开颅减压，p < 0.05）和住院20天（p < 0.05）。结论：这项过早中断的试验显示更多的额外手术和更长的住院时间，但手术的1年血管造影结果更好。EVT和手术的主要临床结局，1年死亡或依赖，相似。
A randomized trial comparing endovascular and surgical management of ruptured intracranial aneurysms excluded from previous trials.
Objective: Many patients with ruptured intracranial aneurysms (RIAs) underrepresented or excluded from previous randomized controlled trials (RCTs) comparing surgery with endovascular treatment (EVT) are still considered for surgical clipping, but the best management of these patients remains unknown.
Methods: The International Subarachnoid Aneurysm Trial-2 was a randomized trial comparing surgical versus EVT of RIAs considered for surgical clipping, despite the results of previous RCTs, and also eligible for EVT. The primary endpoint was death or dependency according to the modified Rankin Scale score (mRS score > 2) at 1 year. Secondary endpoints included 1-year angiographic results and length of hospital stay. The primary hypothesis was that endovascular management would decrease the number of poor outcomes (mRS score > 2) from 30% to 23%, necessitating 1896 patients. The trial was interrupted after 10 years because of slow recruitment. Primary analysis was by intent-to-treat. There was no blinding.
Results: From November 2012 to December 2022, 270 patients were recruited at 6 North American and European centers. After exclusions, 263 patients were randomly allocated to receive surgery (n = 133) or EVT (n = 130). There were 12 crossovers (9 from surgery to EVT). The primary outcome was reached in 40 of 133 surgical patients (30%, 95% CI 23%-38%) compared with 35 of 130 EVT patients (27%, 95% CI 20%-35%) (p = 0.572). Residual aneurysms at 1 year were less frequent with surgery (10/118 [8%, 95% CI 5%-15%]) than EVT (22/109 [20%, 95% CI 14%-29%]) (p = 0.015). Additional procedures (ventricular drainage and decompressive craniotomy, p < 0.05) and hospitalization > 20 days were more frequent in the surgery group (69/133 [52%, 95% CI 43%-60%]) than in the EVT group (38/130 [29%, 95% CI 22%-38%]) (p < 0.001).
Conclusions: This prematurely interrupted trial showed more frequent additional procedures and longer hospitalizations but better 1-year angiographic results with surgery. The primary clinical outcome, death or dependency at 1 year, was similar for EVT and surgery.
期刊介绍：
The Journal of Neurosurgery, Journal of Neurosurgery: Spine, Journal of Neurosurgery: Pediatrics, and Neurosurgical Focus are devoted to the publication of original works relating primarily to neurosurgery, including studies in clinical neurophysiology, organic neurology, ophthalmology, radiology, pathology, and molecular biology. The Editors and Editorial Boards encourage submission of clinical and laboratory studies. Other manuscripts accepted for review include technical notes on instruments or equipment that are innovative or useful to clinicians and researchers in the field of neuroscience; papers describing unusual cases; manuscripts on historical persons or events related to neurosurgery; and in Neurosurgical Focus, occasional reviews. Letters to the Editor commenting on articles recently published in the Journal of Neurosurgery, Journal of Neurosurgery: Spine, and Journal of Neurosurgery: Pediatrics are welcome.
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