International subarachnoid aneurysm trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomised comparison of effects on survival, dependency, seizures, rebleeding, subgroups, and aneurysm occlusion
International subarachnoid aneurysm trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomised comparison of effects on survival, dependency, seizures, rebleeding, subgroups, and aneurysm occlusion
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DOI：
10.1016/s0140-6736(05)67214-5
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发表时间：
2005-09-03
期刊：
影响因子：
168.9
通讯作者：
Sandercock, P
中科院分区：
文献类型：
--
作者：
Molyneux, AJ;Kerr, RSC;Sandercock, P
背景对于破裂的颅内动脉瘤患者，目前有两种治疗方法：血管内可脱性弹簧圈治疗或开颅夹闭。由于这些方法的相对安全性和有效性尚未确定，我们进行了一项随机的多中心试验，以比较适用于任何一种疗法的患者的这些疗法。在这里，我们介绍了治疗一年后的临床结果。方法2143例颅内动脉瘤破裂患者，他们被收治于42个神经外科中心，主要在英国和欧洲。随机分为神经外科夹闭组(n=1070)和血管内栓塞组(n=1073)。主要结果是1岁时死亡或依赖(根据修正的Rankin评分3-6定义)。次要结果包括接受治疗的动脉瘤的再出血和癫痫发作的风险。长期随访仍在继续。分析结果与随机治疗一致。结果我们报告了1073名患者中1063名分配到血管内治疗，1055名患者分配到神经外科治疗的一年结果。被分配到血管内治疗的1 063名患者中有250名(23.5%)在1年内死亡或依赖治疗，而分配到神经外科的1055名患者中有326名(30.9%)，绝对风险降低7.4%(95%CL3.6-11.2，p=0.0001)。早期生存优势可维持长达7年，且显著(对数列p=0.03)。分配到血管内治疗的患者癫痫风险显著降低，但晚期再出血的风险更高。对于适合两种治疗的破裂颅内动脉瘤的患者，血管内弹簧圈比神经外科手术更有可能导致1年的独立生存。修剪；生存益处持续至少7年。晚期再出血的风险很低，但血管内卷绕后比神经外科夹闭后更常见。
Background Two types of treatment are being used for patients with ruptured intracranial aneurysms: endovascular detachable-coil treatment or craniotomy and clipping. We undertook a randomised, multicentre trial to compare these treatments in patients who were suitable for either treatment because the relative safety and efficacy of these approaches had not been established. Here we present clinical outcomes 1 year after treatment.Methods 2143 patients with ruptured intracranial aneurysms, who were admitted to 42 neurosurgical centres, mainly in the UK and Europe, took part in the trial. They were randomly assigned to neurosurgical clipping (n=1070) or endovascular coiling (n=1073). The primary outcome was death or dependence at 1 year (defined by a modified Rankin scale of 3-6). Secondary outcomes included rebleeding from the treated aneurysm and risk of seizures. Long-term follow up continues. Analysis was in accordance with the randomised treatment.Findings We report the 1-year outcomes for 1063 of 1073 patients allocated to endovascular treatment, and 1055 of 1070 patients allocated to neurosurgical treatment. 250 (23.5%) of 1063 patients allocated to endovascular treatment were dead or dependent at 1 year, compared with 326 (30.9%) of 1055 patients allocated to neurosurgery, an absolute risk reduction of 7.4% (95% Cl 3.6-11.2, p=0.0001). The early survival advantage was maintained for up to 7 years and was significant (log rank p=0.03). The risk of epilepsy was substantially lower in patients allocated to endovascular treatment, but the risk of late rebleeding was higher.Interpretation In patients with ruptured intracranial aneurysms suitable for both treatments, endovascular coiling is more likely to result in independent survival at 1 year than neurosurgical. clipping; the survival benefit continues for at least 7 years. The risk of late rebleeding is low, but is more common after endovascular coiling than after neurosurgical clipping.