Raymond J, Klink R, Chagnon M, Barnwell S L, Evans A J, Mocco J, Hoh B H, Turk A S, Turner R D, Desal H, Fiorella D, Bracard S, Weill A, Guilbert F, Lanthier S, Fox A J, Darsaut T E, White P M, Roy D
From the Departments of Radiology (J.R., A.W., F.G., D.R.)
Laboratory of Interventional Neuroradiology (R.K.), Research Centre of the Centre Hospitalier de l'Université de Montreal, Quebec, Canada.
AJNR Am J Neuroradiol. 2017 Mar;38(3):432-441. doi: 10.3174/ajnr.A5101. Epub 2017 Jan 12.
Some patients are at high risk of aneurysm recurrence after endovascular treatment: patients with large aneurysms (Patients Prone to Recurrence After Endovascular Treatment PRET-1) or with aneurysms that have previously recurred after coiling (PRET-2). We aimed to establish whether the use of hydrogel coils improved efficacy outcomes compared with bare platinum coils.
PRET was an investigator-led, pragmatic, multicenter, parallel, randomized (1:1) trial. Randomized allocation was performed separately for patients in PRET-1 and PRET-2, by using a Web-based platform ensuring concealed allocation. The primary outcome was a composite of a residual/recurrent aneurysm, adjudicated by a blinded core laboratory, or retreatment, intracranial bleeding, or mass effect during the 18-month follow-up. Secondary outcomes included adverse events, mortality, and morbidity (mRS > 2). The hypothesis was that hydrogel would decrease the primary outcome from 50% to 30% at 18 months, necessitating 125 patients per group (500 for PRET-1 and PRET-2).
The trial was stopped once 250 patients in PRET-1 and 197 in PRET-2 had been recruited because of slow accrual. A poor primary outcome occurred in 44.4% (95% CI, 35.5%-53.2%) of those in PRET-1 allocated to platinum compared with 52.5% (95% CI, 43.4%-61.6%) of patients allocated to hydrogel (OR, 1.387; 95% CI, 0.838-2.295; = .20) and in 49.0% (95% CI, 38.8%-59.1%) in PRET-2 allocated to platinum compared with 42.1% (95% CI, 32.0%-52.2%) allocated to hydrogel (OR, 0.959; 95% CI, 0.428-1.342; = .34). Adverse events and morbidity were similar. There were 3.6% deaths (1.4% platinum, 5.9% hydrogel; = .011).
Coiling of large and recurrent aneurysms is safe but often poorly effective according to angiographic results. Hydrogel coiling was not shown to be better than platinum.
一些患者在血管内治疗后存在较高的动脉瘤复发风险，如大型动脉瘤患者（血管内治疗后易复发患者-1，PRET-1）或既往弹簧圈栓塞后复发的动脉瘤患者（PRET-2）。我们旨在确定与裸铂弹簧圈相比，水凝胶弹簧圈的使用是否能改善疗效。
PRET是一项由研究者主导、务实、多中心、平行、随机（1:1）试验。通过基于网络的平台对PRET-1和PRET-2的患者分别进行随机分配，确保随机分配的隐匿性。主要结局是由独立核心实验室判定的残余/复发性动脉瘤、再次治疗、颅内出血或18个月随访期间的占位效应的复合结局。次要结局包括不良事件、死亡率和致残率（改良Rankin量表评分>2）。假设是水凝胶在18个月时可将主要结局从50%降至30%，每组需要125例患者（PRET-1和PRET-2共500例）。
由于入组缓慢，在PRET-1招募了250例患者、PRET-2招募了197例患者后试验停止。PRET-1中分配至铂弹簧圈组的患者中44.4%（95%CI，35.5%-53.2%）出现不良主要结局，而分配至水凝胶组的患者中这一比例为52.5%（95%CI，43.4%-61.6%）（OR，1.387；95%CI，0.838-2.295；P = 0.20）；PRET-2中分配至铂弹簧圈组的患者中49.0%（95%CI，38.8%-59.1%）出现不良主要结局，而分配至水凝胶组的患者中这一比例为42.1%（95%CI，32.0%-52.2%）（OR，0.959；95%CI，0.428-1.342；P = 0.34）。不良事件和致残率相似。死亡率为3.6%（铂弹簧圈组1.4%，水凝胶组5.9%；P = 0.011）。
大型和复发性动脉瘤的弹簧圈栓塞是安全的，但根据血管造影结果，疗效往往不佳。水凝胶弹簧圈栓塞并未显示优于铂弹簧圈栓塞。
