Avenir® vs. AxiumTM Coils for the Treatment of Intracranial Aneurysms: Results of a Multicenter Randomized Controlled Trial With Short-Term Follow-Up

Wei Li; Ming Ye; Alexandru Cimpoca; Hans Henkes; Honglei Wang; Xiang Xu; Yuxiang Gu; Huaizhang Shi; Hongming Ji; Feng Wang; Yuanli Zhao; Geng Guo; Hongqi Zhang; Youxiang Li

doi:10.3389/fneur.2021.817989

Avenir® vs. Axium^TM Coils for the Treatment of Intracranial Aneurysms: Results of a Multicenter Randomized Controlled Trial With Short-Term Follow-Up

Front Neurol. 2022 Jan 26:12:817989. doi: 10.3389/fneur.2021.817989. eCollection 2021.

Authors

Wei Li^{1

2}, Ming Ye³, Alexandru Cimpoca⁴, Hans Henkes^{4

5}, Honglei Wang⁶, Xiang Xu⁷, Yuxiang Gu⁸, Huaizhang Shi⁹, Hongming Ji¹⁰, Feng Wang¹¹, Yuanli Zhao¹², Geng Guo¹³, Hongqi Zhang³, Youxiang Li^{1

14}

Affiliations

¹ Department of Interventional Neuroradiology, Beijing Neurosurgical Institute, Beijing Neurosurgical Institute, Capital Medical University, Beijing, China.
² Neurosurgery Department, The Second Affiliated Hospital of Xingtai Medical College, Xingtai, China.
³ Xuanwu Hospital of Capital Medical University, Beijing, China.
⁴ Neuroradiological Clinic, Klinikum Stuttgart, Stuttgart, Germany.
⁵ Medical Faculty, University Duisburg-Essen, Essen, Germany.
⁶ The First Hospital of Jilin University, Jilin, China.
⁷ Tangshan Worker's Hospital, Tangshan, China.
⁸ Huashan Hospital of Fudan University, Beijing, China.
⁹ The First Affiliated Hospital of Harbin Medical University, Harbin, China.
¹⁰ Shanxi Provincial People's Hospital, Taiyuan, China.
¹¹ The First Affiliated Hospital of Dalian Medical University, Dalian, China.
¹² Peking University International Hospital, Beijing, China.
¹³ The First Hospital of Shanxi Medical University, Taiyuan, China.
¹⁴ Beijing Tiantan Hospital of Capital Medical University, Beijing, China.

Abstract

Purpose: 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^TM passive mechanically detachable coil systems.

Methods: 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^TM mechanically detachable coil systems. The short-term outcomes from the two groups were compared with a focus on treatment efficacy and safety.

Results: 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 (p > 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 (p > 0.05). DSA performed at 6 months revealed complete aneurysm occlusion in 84 and 86% of patients in the Avenir and Axium groups, respectively.

Conclusion: We observed no significant short-term differences with respect to efficacy or safety when using either Avenir® or Axium^TM coils for the treatment of intracranial aneurysms.

Keywords: coil occlusion; comparative effectiveness research; endovascular procedures; intracranial aneurysm; safety.