A substudy was carried out of the prospective multicenter randomized controlled EARLYDRAIN trial. We analyzed treatment-associated complications (bleeding and/or infarctions) detected on computed tomography on day 1 after aneurysm occlusion. Outcomes were the occurrence of postprocedural complications, secondary infarctions in the acute phase, and the modified Rankin Scale score after 6 months.
The EARLYDRAIN trial recruited 287 patients in 19 centers. Of these patients, 56 (19.5%) experienced a treatment complication. Twenty-five patients (8.7%) experienced postprocedural intracranial hemorrhage and 34 patients (11.8%) experienced a treatment-associated infarction. Patients with a complication showed more secondary infarctions (P = 0.049) and worse neurologic outcomes after 180 days (P = 0.025) compared with patients with no complication. Aneurysm location, rebleeding before the treatment, number of patients recruited per center, and the day of the treatment were independent risk factors for the occurrence of complications.
The present study shows that patients with aSAH frequently experience intervention-associated complications associated with aneurysm occlusion required to prevent recurrent hemorrhage. Consequently, patients with aSAH with treatment-related complications more often experience a worse clinical course and poor outcome.
方法:这是一项前瞻性多中心随机对照早期治疗试验的子研究。我们分析了动脉瘤闭塞后第1天CT扫描发现的治疗相关并发症(出血和/或梗塞)。结果是术后并发症的发生,急性期继发性梗塞和6个月后的改良等级量表。
结果:Earlydrain试验招募了19个中心的287名患者。其中56(19.5%)患有治疗并发症。25例(8.7%)患者发生术后颅内出血,34例(11.8%)患者发生与治疗相关的梗死。与没有并发症的患者相比,患有并发症的患者在180天后表现出更多的继发性梗塞(p=0.049)和更差的神经系统预后(p=0.025)。动脉瘤位置,治疗前再出血,每个中心招募的患者数量和治疗天数是并发症发生的独立危险因素.
结论:本研究表明,aSAH患者经常经历与动脉瘤闭塞相关的干预并发症,以预防复发性出血。因此,与治疗相关的并发症的SAH患者票价往往更差的临床过程和不良的结果。