Darsaut T E, Roy D, Weill A, Bojanowski M W, Chaalala C, Bilocq A, Findlay J M, Rempel J L, Chow M M, O'Kelly C, Ashforth R A, Kotowski M, Magro E, Lemus M, Fahed R, Arikan F, Arrese I, Sarabia R, Altschul D J, Chagnon M, Guilbert F, Shankar J J S, Proust F, Nolet S, Gevry G, Raymond J
University of Alberta Hospital, Mackenzie Health Sciences Centre, Department of Surgery, Division of Neurosurgery, Edmonton, Alberta, Canada.
Centre Hospitalier de l'Université de Montréal (CHUM), Department of Radiology, Service of Neuroradiology, Montreal, Quebec, Canada.
Neurochirurgie. 2019 Dec;65(6):370-376. doi: 10.1016/j.neuchi.2019.05.008. Epub 2019 Jun 21.
Appropriate management of ruptured intracranial aneurysm (RIA) in patients eligible for surgical clipping but under-represented in or excluded from previous randomized trials remains undetermined.
The International Subarachnoid Aneurysm Trial-2 (ISAT-2) is a randomized care trial comparing surgical versus endovascular treatment (EVT) of RIA. All patients considered for surgical clipping but eligible for endovascular treatment can be included. The primary endpoint is death or dependency on modified Rankin score (mRS>2) at 1 year. Secondary endpoints are 1 year angiographic results and length of hospital stay.
An interim analysis was performed after 103 patients were treated from November 2012 to July 2017 in 4 active centers. Fifty-two of the 55 patients allocated to surgery were treated by clipping, and 45 of the 48 allocated to EVT were treated by coiling, with 3 crossovers in each arm. The main endpoint (1 year mRS>2), available for 76 patients, was reached in 16/42 patients allocated to clipping (38%; 95%CI: 25%-53%), and 10/34 patients allocated to coiling (29%; 17%-46%). One year imaging results were available in 54 patients: complete aneurysm occlusion was found in 23/27 patients allocated to clipping (85%; 67%-94%), and 18/27 patients allocated to coiling (67%; 47%-81%). Hospital stay exceeding 20 days was more frequent in surgery (26/55 [47%; 34%-60%]) than EVT (9/48 [19%; 10%-31%]).
Ruptured aneurysm patients for whom surgical clipping may still be best can be managed in a randomized care trial, which is feasible in some centers. More participating centers are needed.
对于适合进行手术夹闭但在既往随机试验中代表性不足或被排除在外的颅内破裂动脉瘤（RIA）患者，合适的治疗方案仍未确定。
国际蛛网膜下腔动脉瘤试验-2（ISAT-2）是一项随机对照试验，比较RIA的手术治疗与血管内治疗（EVT）。所有考虑进行手术夹闭但适合血管内治疗的患者均可纳入。主要终点是1年时的死亡或改良Rankin量表评分（mRS>2）提示的依赖状态。次要终点是1年时的血管造影结果和住院时间。
2012年11月至2017年7月期间，在4个活跃中心对103例患者进行治疗后进行了中期分析。分配至手术组的55例患者中有52例接受了夹闭治疗，分配至EVT组的48例患者中有45例接受了弹簧圈栓塞治疗，每组各有3例交叉。主要终点（1年时mRS>2），76例患者可用该指标评估，分配至夹闭治疗组的16/42例患者达到该终点（38%；95%CI：25%-53%），分配至弹簧圈栓塞治疗组的10/34例患者达到该终点（29%；17%-46%）。54例患者有1年时的影像学结果：分配至夹闭治疗组的23/27例患者动脉瘤完全闭塞（85%；67%-94%），分配至弹簧圈栓塞治疗组的18/27例患者动脉瘤完全闭塞（67%；47%-81%）。手术组住院时间超过20天的情况比EVT组更常见（26/55 [47%；34%-60%] 对比9/48 [19%；10%-31%]）。
对于手术夹闭可能仍是最佳治疗方法的破裂动脉瘤患者，可以在随机对照试验中进行管理，这在一些中心是可行的。需要更多的参与中心。
