Raymond J, Klink R, Chagnon M, Barnwell S L, Evans A J, Mocco J, Hoh B L, Turk A S, Turner R D, Desal H, Fiorella D, Bracard S, Weill A, Guilbert F, Roy D
From the Department of Radiology (J.R., A.W., F.G., D.R.), Centre Hospitalier de l'Université de Montréal Laboratory of Interventional Neuroradiology (J.R., R.K.), Centre de recherche du Centre Hospitalier de l'Université de Montréal, Notre-Dame Hospital, Montreal, Quebec, Canada
Laboratory of Interventional Neuroradiology (J.R., R.K.), Centre de recherche du Centre Hospitalier de l'Université de Montréal, Notre-Dame Hospital, Montreal, Quebec, Canada.
AJNR Am J Neuroradiol. 2014 Sep;35(9):1667-76. doi: 10.3174/ajnr.A4035. Epub 2014 Jun 19.
Some patients with large or recurrent aneurysms may be at increased risk of recurrence postcoiling. The Patients Prone to Recurrence after Endovascular Treatment (PRET) trial was designed to assess whether hydrogel coils were superior to platinum coils in these high-risk patients. This article reports periprocedural safety and operator-assessed angiographic results from the PRET trial.
PRET was a pragmatic, multicenter, randomized controlled trial. Patients had ≥10-mm aneurysms (PRET-1) or a major recurrence after coiling of an aneurysm of any size (PRET-2). Patients were randomly allocated to hydrogel or control arms (any platinum coil) by using concealed allocation with minimization. Assist devices could be used as clinically required. Aneurysms could be unruptured or recently ruptured. Analyses were on an intent-to-treat basis.
Four hundred forty-seven patients were recruited (250 PRET-1; 197 PRET-2). Aneurysms were recently ruptured in 29% of PRET-1 and 4% of PRET-2 patients. Aneurysms were ≥10 mm in all PRET-1 and in 50% of PRET-2 patients. They were wide-neck (≥4 mm) in 70% and in the posterior circulation in 24% of patients. Stents were used in 28% of patients (35% in PRET-2). Coiling was successful in 98%. Adverse events occurred in 28 patients with hydrogel and 23 with platinum coils. Mortality (n=2, unrelated to treatment) and morbidity (defined as mRS>2 at 1 month) occurred in 25 patients (5.6%; 12 hydrogel, 13 platinum), related to treatment in 10 (4 hydrogel; 6 platinum) (or 2.3% of 444 treated patients). No difference was seen between hydrogel and platinum for any of the indices used to assess safety up to at least 30 days after treatment. At 1 month, 95% of patients were home with a good outcome (mRS≤2 or unchanged). Operator-assessed angiographic outcomes were satisfactory (complete occlusion or residual neck) in 339 of 447 or 76.4% of patients, with no significant difference between groups.
Endovascular treatment of large and recurrent aneurysms can be performed safely with platinum or hydrogel coils.
一些患有大型或复发性动脉瘤的患者在弹簧圈栓塞术后可能有更高的复发风险。血管内治疗后易复发患者（PRET）试验旨在评估在这些高危患者中，水凝胶弹簧圈是否优于铂弹簧圈。本文报告了PRET试验的围手术期安全性和术者评估的血管造影结果。
PRET是一项实用的多中心随机对照试验。患者患有≥10mm的动脉瘤（PRET-1）或任何大小的动脉瘤弹簧圈栓塞术后的主要复发（PRET-2）。采用最小化隐蔽分配将患者随机分配至水凝胶组或对照组（任何铂弹簧圈）。可根据临床需要使用辅助装置。动脉瘤可以是未破裂的或近期破裂的。分析采用意向性分析。
共招募了447例患者（250例PRET-1；197例PRET-2）。29%的PRET-1患者和4%的PRET-2患者的动脉瘤近期破裂。所有PRET-1患者和50%的PRET-2患者的动脉瘤≥10mm。70%的患者动脉瘤为宽颈（≥4mm），24%的患者动脉瘤位于后循环。28%的患者使用了支架（PRET-2中为35%）。弹簧圈栓塞成功率为98%。28例使用水凝胶弹簧圈的患者和23例使用铂弹簧圈的患者发生了不良事件。25例患者（5.6%；12例水凝胶组，13例铂弹簧圈组）出现了死亡（n=2，与治疗无关）和致残（定义为1个月时mRS>2），其中10例（4例水凝胶组；6例铂弹簧圈组）与治疗相关（占444例治疗患者的2.3%）。在治疗后至少30天内用于评估安全性的任何指标上，水凝胶组和铂弹簧圈组之间均未观察到差异。1个月时，95%的患者预后良好（mRS≤2或无变化）且已出院。术者评估的血管造影结果在447例患者中的339例（76.4%）中令人满意（完全闭塞或残留颈部），两组之间无显著差异。
使用铂弹簧圈或水凝胶弹簧圈可安全地对大型和复发性动脉瘤进行血管内治疗。
