Purpose: To analyze the safety of the remodeling technique compared with the safety of the standard treatment with coils for endovascular treatment of unruptured intracranial aneurysms in a large multicenter series of patients as part of the Analysis of Treatment by Endovascular Approach of Nonruptured Aneurysms (ATENA) study.
Materials and methods: The medical ethics committee approved the ATENA study, and all patients gave informed consent for participation in the study. The ATENA study was performed in 27 institutions. For each patient group, we recorded aneurysm characteristics, rate of adverse events related to the treatment, and patient outcome.
Results: In this study, 547 patients (383 women, 164 men; mean age, 51.0 years +/- 11.1 [standard deviation]; range, 22-83 years) with 572 aneurysms were included; 325 patients were treated with coils alone and 222 patients were treated with the remodeling technique. The overall rate of adverse events related to the treatment-regardless of whether the adverse events led to clinical consequences-was 10.8% (35 of 325) for treatment with coils alone and 11.7% (26 of 222) for the remodeling technique. Thromboembolic events, intraoperative rupture, and device-related problems were encountered in 20 (6.2%), seven (2.2%), and eight (2.5%) of 325 patients in the standard treatment group and in 12 (5.4%), seven (3.2%), and seven (3.2%) of 222 patients in the remodeling technique group, respectively. The morbidity and mortality rates did not differ significantly between groups: 2.2% (seven of 325) and 0.9% (three of 325) in the standard treatment group and 2.3% (five of 222) and 1.4% (three of 222) in the remodeling technique group, respectively.
Conclusion: The remodeling technique was associated with a similar rate of adverse events and morbidity and mortality combined compared with the standard treatment with coils, and, thus, the remodeling technique is as safe as the standard treatment with coils.