使用更大口径线圈增加填塞密度能否改善颅内动脉瘤栓塞术 1 年的血管造影结果：一项随机试验。
Does Increasing Packing Density Using Larger Caliber Coils Improve Angiographic Results of Embolization of Intracranial Aneurysms at 1 Year: A Randomized Trial.
机构信息
From the Department of Radiology (J.R., J.G., D.R., A.W.), Service of Interventional Neuroradiology, Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada
From the Department of Radiology (J.R., J.G., D.R., A.W.), Service of Interventional Neuroradiology, Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada.
出版信息
AJNR Am J Neuroradiol. 2020 Jan;41(1):29-34. doi: 10.3174/ajnr.A6362. Epub 2020 Jan 2.
BACKGROUND AND PURPOSE
The impact of increased aneurysm packing density on angiographic outcomes has not been studied in a randomized trial. We sought to determine the potential for larger caliber coils to achieve higher packing densities and to improve the angiographic results of embolization of intracranial aneurysms at 1 year.
MATERIALS AND METHODS
Does Embolization with Larger Coils Lead to Better Treatment of Aneurysms (DELTA) was an investigator-initiated multicenter prospective, parallel, randomized, controlled clinical trial. Patients had 4- to 12-mm unruptured aneurysms. Treatment allocation to either 15- (experimental) or 10-caliber coils (control group) was randomized 1:1 using a Web-based platform. The primary efficacy outcome was a major recurrence or a residual aneurysm at follow-up angiography at 12 ± 2 months adjudicated by an independent core lab blinded to the treatment allocation. Secondary outcomes included indices of treatment success and standard safety outcomes. Recruitment of 564 patients was judged necessary to show a decrease in poor outcomes from 33% to 20% with 15-caliber coils.
RESULTS
Funding was interrupted and the trial was stopped after 210 patients were recruited between November 2013 and June 2017. On an intent-to-treat analysis, the primary outcome was reached in 37 patients allocated to 15-caliber coils and 36 patients allocated to 10-caliber coils (OR = 0.931; 95% CI, 0.528-1.644; = .885). Safety and other clinical outcomes were similar. The 15-caliber coil group had a higher mean packing density (37.0% versus 26.9%, = .0001). Packing density had no effect on the primary outcome when adjusted for initial angiographic results (OR = 1.001; 95% CI, 0.981-1.022; = .879).
CONCLUSIONS
Coiling of aneurysms randomized to 15-caliber coils achieved higher packing densities compared with 10-caliber coils, but this had no impact on the angiographic outcomes at 1 year, which were primarily driven by aneurysm size and initial angiographic results.
背景与目的
增加动脉瘤填塞密度对血管造影结果的影响尚未在随机试验中进行研究。我们旨在确定更大口径的线圈是否有可能实现更高的填塞密度，并改善颅内动脉瘤栓塞治疗 1 年后的血管造影结果。
材料与方法
更大线圈栓塞是否能更好地治疗动脉瘤（DELTA）是一项由研究者发起的多中心前瞻性、平行、随机、对照临床试验。患者患有 4-12mm 未破裂的动脉瘤。使用基于网络的平台，以 1:1 的比例将患者随机分配至 15 号（实验组）或 10 号线圈（对照组）。主要疗效终点是在 12±2 个月的随访血管造影中出现主要复发或残余动脉瘤，由独立核心实验室盲法评估，该实验室不了解治疗分配情况。次要结局包括治疗成功的指标和标准安全性结局。研究人员判断需要招募 564 名患者，以显示用 15 号线圈治疗时不良结局从 33%下降到 20%。
结果
在 2013 年 11 月至 2017 年 6 月期间，招募了 210 名患者后，研究中断并停止。在意向治疗分析中，37 名分配到 15 号线圈的患者和 36 名分配到 10 号线圈的患者达到了主要结局（OR=0.931；95%CI，0.528-1.644；=0.885）。安全性和其他临床结局相似。15 号线圈组的平均填塞密度更高（37.0%对 26.9%，=0.0001）。当调整初始血管造影结果时，填塞密度对主要结局没有影响（OR=1.001；95%CI，0.981-1.022；=0.879）。
结论
与 10 号线圈相比，随机分配到 15 号线圈的动脉瘤填塞密度更高，但这对 1 年后的血管造影结果没有影响，主要受动脉瘤大小和初始血管造影结果的影响。
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