Li Wei, Ye Ming, Cimpoca Alexandru, Henkes Hans, Wang Honglei, Xu Xiang, Gu Yuxiang, Shi Huaizhang, Ji Hongming, Wang Feng, Zhao Yuanli, Guo Geng, Zhang Hongqi, Li Youxiang
Department of Interventional Neuroradiology, Beijing Neurosurgical Institute, Beijing Neurosurgical Institute, Capital Medical University, Beijing, China.
Neurosurgery Department, The Second Affiliated Hospital of Xingtai Medical College, Xingtai, China.
Front Neurol. 2022 Jan 26;12:817989. doi: 10.3389/fneur.2021.817989. eCollection 2021.
Endovascular coil occlusion is a successful and rapidly evolving strategy used to treat patients who present with intracranial aneurysms. This study aimed to compare the safety and efficacy of the Avenir® and Axium passive mechanically detachable coil systems.
A prospective, multicenter, randomized controlled study was carried out at ten medical centers from March 2018 to December 2019. A series of consecutive patients diagnosed with intracranial aneurysms were randomly assigned to undergo endovascular treatment with either the Avenir® or the Axium mechanically detachable coil systems. The short-term outcomes from the two groups were compared with a focus on treatment efficacy and safety.
A total of 162 and 161 patients were enrolled in the Avenir and Axium groups, respectively. The rate of successful coil detachment was 100% for the Avenir group and 99.38% for the Axium group. At the six-month follow-up visit, the overall aneurysm occlusion rate was 94.66% for the Avenir group and 96.95% for the Axium group ( > 0.05). We observed no statistically significant differences in clinical condition (as per the modified Rankin Scale) or the degree of aneurysm occlusion (as determined by digital subtraction angiography [DSA] and Raymond-Roy Occlusion Classification). Surgical complications were reported in 27 subjects in the Avenir group and 22 in the Axium group ( > 0.05). DSA performed at 6 months revealed complete aneurysm occlusion in 84 and 86% of patients in the Avenir and Axium groups, respectively.
We observed no significant short-term differences with respect to efficacy or safety when using either Avenir® or Axium coils for the treatment of intracranial aneurysms.
血管内弹簧圈栓塞术是治疗颅内动脉瘤患者的一种成功且快速发展的策略。本研究旨在比较Avenir®和Axium被动机械可脱卸弹簧圈系统的安全性和有效性。
2018年3月至2019年12月在10个医疗中心进行了一项前瞻性、多中心、随机对照研究。一系列连续诊断为颅内动脉瘤的患者被随机分配接受使用Avenir®或Axium机械可脱卸弹簧圈系统进行血管内治疗。比较两组的短期结果，重点关注治疗效果和安全性。
Avenir组和Axium组分别纳入了162例和161例患者。Avenir组弹簧圈成功解脱率为100%，Axium组为99.38%。在六个月的随访中，Avenir组的总体动脉瘤闭塞率为94.66%，Axium组为96.95%（>0.05）。我们观察到在临床状况（根据改良Rankin量表）或动脉瘤闭塞程度（通过数字减影血管造影[DSA]和Raymond-Roy闭塞分类确定）方面没有统计学上的显著差异。Avenir组有27例患者报告了手术并发症，Axium组有22例（>0.05）。6个月时进行的DSA显示，Avenir组和Axium组分别有84%和86%的患者动脉瘤完全闭塞。
在使用Avenir®或Axium弹簧圈治疗颅内动脉瘤时，我们观察到在疗效或安全性方面没有显著的短期差异。
