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OBJECTIVE: Endovascular treatment of large, wide-necked intracranial aneurysms by coil embolization is often complicated by low rates of complete occlusion and high rates of recurrence. A flow diverter device has been shown to be safe and effective for the treatment of not only large and giant unruptured aneurysms, but small and medium aneurysms. However, in Korea, its use has only recently been approved for aneurysms <10 mm. This study aims to compare the safety and efficacy of flow diversion and coil embolization for the treatment of unruptured aneurysms ≥7 mm. METHODS: The participants will include patients aged between 19 and 75 years to be treated for unruptured cerebral aneurysms ≥7 mm for the first time or for recurrent aneurysms after initial endovascular coil embolization. Participants assigned to a flow diversion cohort will be treated using any of the following devices : Pipeline Flex Embolization Device with Shield Technology (Medtronic, Minneapolis, MN, USA), Surpass Evolve (Stryker Neurovascular, Fremont, CA, USA), and FRED or FRED Jr. (MicroVention, Tustin, CA, USA). Participants assigned to a coil embolization cohort will undergo traditional endovascular coiling. The primary endpoint will be complete occlusion confirmed by cerebral angiography at 12 months after treatment. Secondary safety outcomes will evaluate periprocedural and post-procedural complications for up to 12 months. RESULTS: The trial will begin enrollment in 2022, and clinical data will be available after enrollment and follow-up. CONCLUSION: This article describes the aim and design of a multi-center, randomized, open-label trial to compare the safety and efficacy of flow diversion versus traditional endovascular treatment for unruptured cerebral aneurysms ≥7 mm.
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BACKGROUND: Two primary treatment methods are used for ruptured cerebral aneurysms, surgical clipping and endovascular coiling. In recent decades, endovascular coiling has shown remarkable progress compared to surgical clipping, along with technological developments. The aim of this study was to investigate the recent trends in treatments for ruptured cerebral aneurysms in Korea. METHODS: The data were obtained from the National Health Insurance database. We evaluated the trends in endovascular coiling and surgical clipping for ruptured aneurysms for the period 2000-2017. We obtained the number of prescriptions with International Classification of Diseases, 9th Revision, clinical modification codes related to nontraumatic subarachnoid hemorrhage and prescription codes S4641/4642 for surgical clipping and M1661/1662 for endovascular coiling. The medical expenses for each prescription were also obtained. The primary outcomes included the cumulative number of patients, patient rates per 100,000 people, and the correlation between patient rates and the percentage of the population in each age group. RESULTS: In the case of surgical clipping, there were no increasing or decreasing trends in the cumulative number of patients when the population/age group was ignored. When examining the trends in patient rates per 100,000 population at each year in male, there was no increasing or decreasing trend in the number of surgical clippings between the age groups, in spite of a decreasing tendency in the number of surgical clipping in male in their 40s and older than 60. In females, the surgical clipping rates tended to decrease only in patients older than 60 years, but there was no tendency to increase or decrease in the other ages. In contrast, the cumulative number of patients who underwent endovascular coiling for ruptured cerebral aneurysms increased year by year regardless of the population/age group. In both male and female, there was no increasing or decreasing trend only in the group aged 40 or younger and there was an increasing tendency in the rest of the age groups. In the trend of medical expenses, both the cost of surgical clipping and endovascular coiling showed increases. Specifically, the medical expense trend in endovascular coiling increased more rapidly than that for surgical clipping. CONCLUSION: There was a significant increase in the proportion of patients with ruptured aneurysms undergoing endovascular coiling between 2010 and 2017, whereas the use of surgical clipping decreased. The endovascular coiling was significantly increased in all age groups and surgical clipping was decreased in all age groups, especially in patients under 50 years of age.