用于颅内动脉瘤血管内治疗的第二代水凝胶弹簧圈：一项随机对照试验
Second-Generation Hydrogel Coils for the Endovascular Treatment of Intracranial Aneurysms: A Randomized Controlled Trial.
作者信息
Taschner Christian A, Chapot René, Costalat Vincent, Machi Paolo, Courthéoux Patrick, Barreau Xavier, Berge Jérôme, Pierot Laurent, Kadziolka Krzysztof, Jean Betty, Blanc Raphaël, Biondi Alessandra, Brunel Hervé, Gallas Sophie, Berlis Ansgar, Herbreteau Denis, Berkefeld Joachim, Urbach Horst, Elsheikh Samer, Fiehler Jens, Desal Hubert, Graf Erika, Bonafé Alain
机构信息
From the Department of Neuroradiology (C.A.T., H.U., S.E.) and Clinical Trials Unit (E.G.), Faculty of Medicine, Medical Center-University of Freiburg, University of Freiburg, Germany; Department of Intracranial Endovascular Therapy, Alfried-Krupp Krankenhaus, Essen, Germany (R.C.); Department of Neuroradiology, Centre Hospitalier Universitaire Montpellier, France (V.C., P.M., A.B.); Department of Neuroradiology, Centre Hospitalier Universitaire Caen, France (P.C.); Department of Neuroradiology, Centre Hospitalier Universitaire Bordeaux, France (X.B., J.B.); Department of Neuroradiology, Centre Hospitalier Universitaire Reims, France (L.P., K.K.); Department of Neuroradiology, Centre Hospitalier Universitaire Clermont-Ferrand, France (B.J.); Department of Interventional Neuroradiology, Fondation Rothschild Hospital, Paris, France (R.B.); Department of Neuroradiology, Centre Hospitalier Universitaire Besançon, France (A.B.); Department of Neuroradiology, Centre Hospitalier Universitaire Marseille, France (H.B.); Department of Neuroradiology, Hôpital Henri-Mondor, Créteil, France (S.G.); Department of Neuroradiology, Augsburg Hospital, Germany (A.B.); Department of Neuroradiology, Centre Hospitalier Universitaire Tours, France (D.H.); Institute of Neuroradiology, University Hospital Frankfurt, Germany (J.B.); Department of Neuroradiology, University Hospital Hamburg-Eppendorf, Germany (J.F.); and Department of Neuroradiology, Centre Hospitalier Universitaire Nantes, France (H.D.).
出版信息
Stroke. 2018 Mar;49(3):667-674. doi: 10.1161/STROKEAHA.117.018707. Epub 2018 Feb 6.
BACKGROUND AND PURPOSE
Endovascular embolization of intracranial aneurysms with hydrogel-coated coils lowers the risk of major recurrence, but technical limitations (coil stiffness and time restriction for placement) have prevented their wider clinical use. We aimed to assess the efficacy of softer, second-generation hydrogel coils.
METHODS
A randomized controlled trial was conducted at 22 centers in France and Germany. Patients aged 18 to 75 years with untreated ruptured or unruptured intracranial aneurysms measuring 4 to 12 mm in diameter were eligible and randomized (1:1 using a web-based system, stratified by rupture status) to coiling with either second-generation hydrogel coils or bare platinum coils. Assist devices were allowed as clinically required. Independent imaging core laboratory was masked to allocation. Primary end point was a composite outcome measure including major aneurysm recurrence, aneurysm retreatment, morbidity that prevented angiographic controls, and any death during treatment and follow-up. Data were analyzed as randomized.
RESULTS
Randomization began on October 15, 2009, and stopped on January 31, 2014, after 513 patients (hydrogel, n=256; bare platinum, n=257); 20 patients were excluded for missing informed consent and 9 for treatment-related criteria. Four hundred eighty-four patients (hydrogel, n=243; bare platinum, n=241) were included in the analysis; 208 (43%) were treated for ruptured aneurysms. Final end point data were available for 456 patients. Forty-five out of 226 (19.9%) patients in the hydrogel group and 66/230 (28.7%) in the control group had an unfavorable composite primary outcome, giving a statistically significant reduction in the proportion of an unfavorable composite primary outcome with hydrogel coils-adjusted for rupture status-of 8.4% (95% confidence interval, 0.5-16.2; =0.036). Adverse and serious adverse events were evenly distributed between groups.
CONCLUSIONS
Our results suggest that endovascular coil embolization with second-generation hydrogel coils may reduce the rate of unfavorable outcome events in patients with small- and medium-sized intracranial aneurysms.
CLINICAL TRIAL REGISTRATION
URL: https://www.drks.de/drks_web/. Unique identifier: DRKS00003132.
背景与目的
使用水凝胶涂层弹簧圈进行颅内动脉瘤的血管内栓塞可降低主要复发风险，但技术限制（弹簧圈硬度和放置时间限制）阻碍了其更广泛的临床应用。我们旨在评估更柔软的第二代水凝胶弹簧圈的疗效。
方法
在法国和德国的22个中心进行了一项随机对照试验。年龄在18至75岁、患有未经治疗的直径为4至12毫米的破裂或未破裂颅内动脉瘤的患者符合条件，并被随机分组（使用基于网络的系统按1:1比例，根据破裂状态分层），分别使用第二代水凝胶弹簧圈或裸铂弹簧圈进行栓塞治疗。根据临床需要允许使用辅助装置。独立影像核心实验室对分组情况保密。主要终点是一个综合结局指标，包括主要动脉瘤复发、动脉瘤再次治疗、妨碍血管造影检查的并发症以及治疗和随访期间的任何死亡。数据按随机分组进行分析。
结果
随机分组于2009年10月15日开始，在纳入513例患者（水凝胶组，n = 256；裸铂组，n = 257）后于2014年1月31日停止；20例患者因缺少知情同意书被排除，9例因治疗相关标准被排除。484例患者（水凝胶组，n = 243；裸铂组，n = 241）纳入分析；208例（43%）患者治疗的是破裂动脉瘤。456例患者可获得最终终点数据。水凝胶组226例患者中有45例（19.9%）、对照组230例患者中有66例（28.7%）出现不良综合主要结局，经破裂状态调整后，水凝胶弹簧圈使不良综合主要结局比例有统计学意义地降低了8.4%（95%置信区间，0.5 - 16.2；P = 0.036）。不良事件和严重不良事件在两组间分布均匀。
结论
我们的结果表明，使用第二代水凝胶弹簧圈进行血管内弹簧圈栓塞可能降低中小型颅内动脉瘤患者不良结局事件的发生率。
临床试验注册
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