Molyneux Andrew, Kerr Richard, Stratton Irene, Sandercock Peter, Clarke Mike, Shrimpton Julia, Holman Rury
ISAT, Neurovascular Research Unit, Radcliffe Infirmary, Oxford OX2 6HE, UK.
Lancet. 2002 Oct 26;360(9342):1267-74. doi: 10.1016/s0140-6736(02)11314-6.
Endovascular detachable coil treatment is being increasingly used as an alternative to craniotomy and clipping for some ruptured intracranial aneurysms, although the relative benefits of these two approaches have yet to be established. We undertook a randomised, multicentre trial to compare the safety and efficacy of endovascular coiling with standard neurosurgical clipping for such aneurysms judged to be suitable for both treatments.
We enrolled 2143 patients with ruptured intracranial aneurysms and randomly assigned them to neurosurgical clipping (n=1070) or endovascular treatment by detachable platinum coils (n=1073). Clinical outcomes were assessed at 2 months and at 1 year with interim ascertainment of rebleeds and death. The primary outcome was the proportion of patients with a modified Rankin scale score of 3-6 (dependency or death) at 1 year. Trial recruitment was stopped by the steering committee after a planned interim analysis. Analysis was per protocol.
190 of 801 (23.7%) patients allocated endovascular treatment were dependent or dead at 1 year compared with 243 of 793 (30.6%) allocated neurosurgical treatment (p=0.0019). The relative and absolute risk reductions in dependency or death after allocation to an endovascular versus neurosurgical treatment were 22.6% (95% CI 8.9-34.2) and 6.9% (2.5-11.3), respectively. The risk of rebleeding from the ruptured aneurysm after 1 year was two per 1276 and zero per 1081 patient-years for patients allocated endovascular and neurosurgical treatment, respectively.
In patients with a ruptured intracranial aneurysm, for which endovascular coiling and neurosurgical clipping are therapeutic options, the outcome in terms of survival free of disability at 1 year is significantly better with endovascular coiling. The data available to date suggest that the long-term risks of further bleeding from the treated aneurysm are low with either therapy, although somewhat more frequent with endovascular coiling.
血管内可脱性弹簧圈治疗正越来越多地被用作某些破裂颅内动脉瘤开颅夹闭术的替代方法，尽管这两种方法的相对益处尚未明确。我们进行了一项随机、多中心试验，以比较血管内弹簧圈栓塞术与标准神经外科夹闭术对判定适合两种治疗的此类动脉瘤的安全性和有效性。
我们纳入了2143例破裂颅内动脉瘤患者，并将他们随机分配至神经外科夹闭术组（n = 1070）或可脱性铂弹簧圈血管内治疗组（n = 1073）。在2个月和1年时评估临床结局，并对再出血和死亡进行中期确定。主要结局是1年时改良Rankin量表评分为3 - 6分（依赖或死亡）的患者比例。在计划的中期分析后，指导委员会停止了试验招募。分析按方案进行。
分配至血管内治疗的801例患者中有190例（23.7%）在1年时依赖或死亡，而分配至神经外科治疗的793例患者中有243例（30.6%）（p = 0.0019）。分配至血管内治疗与神经外科治疗后依赖或死亡的相对和绝对风险降低分别为22.6%（95%CI 8.9 - 34.2）和6.9%（2.5 - 11.3）。分配至血管内和神经外科治疗的患者，破裂动脉瘤1年后再出血风险分别为每1276患者年2例和每1081患者年0例。
对于破裂颅内动脉瘤患者，血管内弹簧圈栓塞术和神经外科夹闭术均为治疗选择，血管内弹簧圈栓塞术在1年时无残疾生存方面的结局显著更好。迄今可得的数据表明，两种治疗方法中经治疗的动脉瘤进一步出血的长期风险均较低，尽管血管内弹簧圈栓塞术稍更常见。
