Department of Neuroradiology, Reims University, Hôpital Maison-Blanche, 45 rue Cognacq-Jay, 51092 Reims, France.
Radiology. 2011 Feb;258(2):546-53. doi: 10.1148/radiol.10100894. Epub 2010 Dec 3.
To compare the safety and efficacy of the remodeling technique with that of conventional coil embolization in a large multicenter series involving the endovascular treatment of ruptured intracranial aneurysms, the CLARITY study (Clinical and Anatomic Results in the Treatment of Ruptured Intracranial Aneurysms).
The institutional review board approved the CLARITY study, and written informed consent was obtained from all patients. A total of 768 patients (age range, 19-80 years; mean age ± standard deviation, 51.0 years ± 11.1) with 768 ruptured aneurysms were treated with either conventional coil embolization (608 patients, 79.2%) or the remodeling technique (160 patients, 20.8%). Patient and aneurysm characteristics, the rate of adverse events related to the treatment or initial intracranial hemorrhage, and patient outcome were compared between treatment groups by using the χ(2), Fisher exact, or Student t test.
The overall rate of treatment-related complications, with or without clinical manifestations, was 17.4% (106 of 608 patients) with coil embolization and 16.9% (27 of 160 patients) with remodeling (P = .999). The difference in the rates of thromboembolic events, intraoperative rupture, and early repeat bleeding between the treatment groups was not statistically significant. The cumulative morbidity and mortality rate related to the treatment in the remodeling group (3.8%, six of 160 patients) was similar to that in the coil embolization group (5.1%, 31 of 608 patients) (P = .678). Likewise, the global cumulative morbidity and mortality rates related to both the treatment and the initial hemorrhage did not differ significantly between groups (16.2% [26 of 160 patients] with remodeling and 19.6% [119 of 608 patients] with coil embolization, P = .366). The rate of adequate aneurysm occlusion, however, was significantly higher in the remodeling group (94.9%, 150 of 158 aneurysms) than in the coil embolization group (88.7%, 534 of 602 aneurysms) (P = .017).
In our large series of patients treated for ruptured aneurysms, the remodeling technique-despite being performed in aneurysms with unfavorable characteristics-was as safe as conventional coil embolization and more efficacious in terms of the rate of adequate postoperative occlusion. These results indicate that the remodeling technique can be routinely used in the treatment of ruptured aneurysms.
比较重塑技术与传统线圈栓塞治疗颅内破裂动脉瘤的安全性和疗效，该研究为 CLARITY 研究（颅内破裂动脉瘤治疗的临床和解剖结果）。
该机构审查委员会批准了 CLARITY 研究，并获得了所有患者的书面知情同意。共治疗了 768 例（年龄 19-80 岁；平均年龄±标准差，51.0 岁±11.1 岁）破裂性颅内动脉瘤，分别采用传统线圈栓塞（608 例，79.2%）或重塑技术（160 例，20.8%）。通过 χ(2)、Fisher 确切检验或学生 t 检验比较治疗组间患者和动脉瘤特征、与治疗相关的不良事件发生率（无论有无临床表现）以及患者结局。
采用线圈栓塞治疗的患者，治疗相关并发症发生率为 17.4%（106/608 例），采用重塑技术治疗的患者为 16.9%（27/160 例）（P=.999）。两组间血栓栓塞事件、术中破裂和早期再出血发生率的差异无统计学意义。重塑组（3.8%，160 例患者中有 6 例）与线圈栓塞组（5.1%，608 例患者中有 31 例）治疗相关的累积发病率和死亡率相似（P=.678）。同样，两组治疗和初始出血相关的总体累积发病率和死亡率差异无统计学意义（重塑组 16.2%[160 例患者中有 26 例]，线圈栓塞组 19.6%[608 例患者中有 119 例]，P=.366）。然而，重塑组的动脉瘤完全闭塞率（94.9%，158 个动脉瘤中有 150 个）明显高于线圈栓塞组（88.7%，602 个动脉瘤中有 534 个）（P=.017）。
在我们对破裂性动脉瘤患者的大型系列研究中，尽管重塑技术应用于具有不利特征的动脉瘤，但与传统线圈栓塞相比，安全性相当，在术后充分闭塞率方面更有效。这些结果表明，重塑技术可常规用于治疗破裂性动脉瘤。
