Purpose: 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).
Materials and methods: 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.
Results: 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).
Conclusion: 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.
© RSNA, 2010.