Bengt Karlsson1, Hidefumi Jokura2, Huai-Che Yang3,4, Masaaki Yamamoto5, Roberto Martinez6, Jun Kawagishi2, Wan-Yuo Guo3, Guus Beute7, David H C Pan3, Hitoshi Aiyama5, Wen-Yuh Chung3, Michael Söderman8, Tseng Tsai Yeo1. 1. Department of Surgery, Division of Neurosurgery, National University Hospital, Singapore, Singapore. 2. Jiro Suzuki Memorial Gamma House, Furukawa Seiryo Hospital, Furukawa, Japan. 3. Department of Neurosurgery, Veterans General Hospital, Taipei, Taiwan. 4. National Yang-Ming University, Taipei, Taiwan. 5. Katsuta Hospital Mito GammaHouse, Ibaraki, Japan. 6. Ruber International Hospital, Madrid, Spain. 7. St Elizabeth Ziekenhuis, Tilburg, the Netherlands. 8. Department of Neuroradiology, Karolinska Hospital, Stockholm, Sweden.
Abstract
BACKGROUND: The optimal management of unruptured brain arteriovenous malformations (AVMs) is controversial after the ARUBA trial. OBJECTIVE: To confirm or repudiate the ARUBA conclusion that "medical management only is superior to medical management with interventional therapy for unruptured brain arteriovenous malformations." METHODS: Data were collected from 1351 patients treated with Gamma Knife Surgery (GKS; Elekta AB, Stockholm, Sweden) for unruptured and untreated AVMs The follow-up was 8817 yr (median 5.0 and mean 6.5). The results of the analyses were compared to that found in patients randomized to medical management only in the ARUBA trial and extrapolated to a 10-yr time period. Our data were also compared to the natural course in a virtual AVM population for a 25-yr time period. RESULTS: The incidence of stroke was similar among ARUBA and our patients for the first 5 yr. Thereafter, the longer the follow-up, the relatively better outcome following treatment. Both the mortality rate and the incidence of permanent deficits in patients with small AVMs were the same as in untreated patients for the first 2 to 3 yr after GKS, after which GKS patients did better. Patients with large AVMs had a higher incidence of neurological deficits in the first 3 yr following GKS. The difference decreased thereafter, but the time until break even depended on the analysis method used and the assumed risk for hemorrhage in patent AVMs. CONCLUSION: The ARUBA trial conclusion that medical management is superior to medical management with interventional therapy for all unruptured AVMs could be repudiated.
RCT Entities:
BACKGROUND: The optimal management of unruptured brain arteriovenous malformations (AVMs) is controversial after the ARUBA trial. OBJECTIVE: To confirm or repudiate the ARUBA conclusion that "medical management only is superior to medical management with interventional therapy for unruptured brain arteriovenous malformations." METHODS: Data were collected from 1351 patients treated with Gamma Knife Surgery (GKS; Elekta AB, Stockholm, Sweden) for unruptured and untreated AVMs The follow-up was 8817 yr (median 5.0 and mean 6.5). The results of the analyses were compared to that found in patients randomized to medical management only in the ARUBA trial and extrapolated to a 10-yr time period. Our data were also compared to the natural course in a virtual AVM population for a 25-yr time period. RESULTS: The incidence of stroke was similar among ARUBA and our patients for the first 5 yr. Thereafter, the longer the follow-up, the relatively better outcome following treatment. Both the mortality rate and the incidence of permanent deficits in patients with small AVMs were the same as in untreated patients for the first 2 to 3 yr after GKS, after which GKS patients did better. Patients with large AVMs had a higher incidence of neurological deficits in the first 3 yr following GKS. The difference decreased thereafter, but the time until break even depended on the analysis method used and the assumed risk for hemorrhage in patent AVMs. CONCLUSION: The ARUBA trial conclusion that medical management is superior to medical management with interventional therapy for all unruptured AVMs could be repudiated.
Authors: A I Qureshi; O Saeed; S Sahito; I Lobanova; J Liaqat; F Siddiq; C R Gomez Journal: AJNR Am J Neuroradiol Date: 2020-02-27 Impact factor: 3.825