Molyneux Andrew J, Birks Jacqueline, Clarke Alison, Sneade Mary, Kerr Richard S C
Oxford Neurovascular and Neuroradiology Research Unit, Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.
Centre for Statistics in Medicine, Oxford, UK.
Lancet. 2015 Feb 21;385(9969):691-7. doi: 10.1016/S0140-6736(14)60975-2. Epub 2014 Oct 28.
Previous analyses of the International Subarachnoid Aneurysm Trial (ISAT) cohort have reported on the risks of recurrent subarachnoid haemorrhage and death or dependency for a minimum of 5 years and up to a maximum of 14 years after treatment of a ruptured intracranial aneurysm with either neurosurgical clipping or endovascular coiling. At 1 year there was a 7% absolute and a 24% relative risk reduction of death and dependency in the coiling group compared with the clipping group, but the medium-term results showed the increased need for re-treatment of the target aneurysm in the patients given coiling. We report the long-term follow-up of patients in this UK cohort.
In ISAT, patients were randomly allocated to either neurosurgical clipping or endovascular coiling after a subarachnoid haemorrhage, assuming treatment equipoise, between Sept 12, 1994, and May 1, 2002. We followed up 1644 patients in 22 UK neurosurgical centres for death and clinical outcomes for 10·0-18·5 years. We assessed dependency as self-reported modified Rankin scale score obtained through yearly questionnaires. Data for recurrent aneurysms and rebleeding events were collected from questionnaires and from hospital and general practitioner records. The Office for National Statistics supplied data on deaths. This study is registered, number ISRCTN49866681.
At 10 years, 674 (83%) of 809 patients allocated endovascular coiling and 657 (79%) of 835 patients allocated neurosurgical clipping were alive (odds ratio [OR] 1·35, 95% CI 1·06-1·73). Of 1003 individuals who returned a questionnaire at 10 years, 435 (82%) patients treated with endovascular coiling and 370 (78%) patients treated with neurosurgical clipping were independent (modified Rankin scale score 0-2; OR 1·25; 95% CI 0·92-1·71). Patients in the endovascular treatment group were more likely to be alive and independent at 10 years than were patients in the neurosurgery group (OR 1·34, 95% CI 1·07-1·67). 33 patients had a recurrent subarachnoid haemorrhage more than 1 year after their initial haemorrhage (17 from the target aneurysm).
Although rates of increased dependency alone did not differ between groups, the probability of death or dependency was significantly greater in the neurosurgical group than in the endovascular group. Rebleeding was more likely after endovascular coiling than after neurosurgical clipping, but the risk was small and the probability of disability-free survival was significantly greater in the endovascular group than in the neurosurgical group at 10 years.
UK Medical Research Council.
既往对国际蛛网膜下腔动脉瘤试验（ISAT）队列的分析报告了颅内破裂动脉瘤采用神经外科夹闭术或血管内栓塞治疗后至少5年、最长14年的复发性蛛网膜下腔出血以及死亡或致残的风险。在1年时，与夹闭组相比，栓塞组的死亡和致残绝对风险降低了7%，相对风险降低了24%，但中期结果显示接受栓塞治疗的患者对目标动脉瘤进行再次治疗的需求增加。我们报告了该英国队列患者的长期随访情况。
在ISAT研究中，1994年9月12日至2002年5月1日期间，假设治疗均衡，蛛网膜下腔出血后的患者被随机分配至神经外科夹闭术组或血管内栓塞组。我们在英国22个神经外科中心对1644例患者进行了10.0 - 18.5年的死亡和临床结局随访。我们将依赖程度评估为通过年度问卷获得的自我报告的改良Rankin量表评分。复发性动脉瘤和再出血事件的数据通过问卷以及医院和全科医生记录收集。英国国家统计局提供了死亡数据。本研究已注册，注册号为ISRCTN49866681。
10年时，809例接受血管内栓塞治疗的患者中有674例（83%）存活，835例接受神经外科夹闭治疗的患者中有657例（79%）存活（比值比[OR]为1.35，95%置信区间为1.06 - 1.73）。在10年时返回问卷的1003人中，435例（82%）接受血管内栓塞治疗的患者和370例（78%）接受神经外科夹闭治疗的患者为独立状态（改良Rankin量表评分为0 - 2；OR为1.25；95%置信区间为0.92 - 1.71）。血管内治疗组患者在10年时比神经外科组患者更有可能存活且独立（OR为1.34，95%置信区间为1.07 - 1.67）。33例患者在首次出血1年多后发生了复发性蛛网膜下腔出血（17例来自目标动脉瘤）。
尽管仅依赖程度增加的发生率在两组之间无差异，但神经外科组的死亡或依赖概率显著高于血管内组。血管内栓塞后再出血比神经外科夹闭后更有可能发生，但风险较小，且血管内组在10年时无残疾生存的概率显著高于神经外科组。
英国医学研究理事会。
