2143例破裂颅内动脉瘤患者神经外科手术夹闭对比血管内弹簧圈栓塞的ISAT（International Subarachnoid Aneurysm Trial）试验：存活率、致残率、癫痫发作、再出血、亚组和动脉瘤闭塞等疗效的随机比较
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
背景：血管内可解脱弹簧圈治疗和开颅夹闭是用于破裂颅内动脉瘤破裂患者的两种治疗方法。鉴于上述两种方法的相对安全性和有效性尚未确定，我们开展了一项随机、多中心试验，选取同时适用于两种治疗的患者，对两种治疗进行了比较。我们在此报告治疗后1年的临床结果。
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.
方法：本试验纳入了来自主要位于英国和欧洲其他国家的42家神经外科中心的2143例破裂颅内动脉瘤患者，并将其随机分为神经外科手术夹闭组（n=1070）和血管内弹簧圈栓塞组（n=1073）。主要结局为术后1年死亡或残疾（改良Rankin量表3-6分），次要结局包括动脉瘤治疗后再出血和癫痫发作风险。持续长期随访，分析符合随机治疗。
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.
结果：我们报告了1063/1073例接受血管内治疗的患者和1055/1070例接受神经外科手术治疗的患者1年随访结果。接受血管内治疗的1063例患者1年随访死亡或残疾者250例（23.5%），与之相比，接受神经外科手术治疗的1055例患者则为326例（30.9%），绝对风险降低了7.4%（95% CI：3.6–11.2，P=0.0001）。早期存活优势可持续7年以上，具有显着性（对数秩，P=0.03）。接受血管内治疗的患者发生癫痫的风险显着降低，但是晚期再出血的风险更高。
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% CI 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.
解读：对于同时适用于两种治疗的破裂颅内动脉瘤患者，1年随访，血管内弹簧圈栓塞较之神经外科手术夹闭更有可能导致独立存活；生存获益至少持续7年。虽然晚期再出血的风险很低，但是血管内栓塞治疗者较之神经外科手术夹闭者更为多见。
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.
原文出处：Molyneux AJ, Kerr RS, Yu LM, et al. 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. Lancet, ; 366: 809-17.
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