ARUBA trial: Difference between revisions
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Medical management alone was found to be superior to interventional therapy for the prevention of death or stroke in patients with unruptured brain AVMs over a mean follow-up of 33 months. These results suggest that medical management should be preferred, and the trial continues with an observational phase to assess long-term outcomes. | Medical management alone was found to be superior to interventional therapy for the prevention of death or stroke in patients with unruptured brain AVMs over a mean follow-up of 33 months. These results suggest that medical management should be preferred, and the trial continues with an observational phase to assess long-term outcomes. | ||
=== | === Criticism === | ||
* Grouping of various treatment modalities as one group | |||
* Study was aborted after median F/U of only 33 m | |||
* Selection bias: Majority of S-M I / II were not treated microsurgically despite being the treatment of choice | |||
* Inclusion of high-grade AVM’s | |||
* Most AVM’s were treated with embo’ alone | |||
=== Reference === | === Reference === | ||
Mohr JP, Parides MK, Stapf C, et al. Medical management with or without interventional therapy for unruptured brain [[Arteriovenous Malformations|arteriovenous malformations]] (ARUBA): a multicentre, non-blinded, randomised trial. ''Lancet'' 2014; 383: 614–21. | Mohr JP, Parides MK, Stapf C, et al. Medical management with or without interventional therapy for unruptured brain [[Arteriovenous Malformations|arteriovenous malformations]] (ARUBA): a multicentre, non-blinded, randomised trial. ''Lancet'' 2014; 383: 614–21. | ||
{{#fas: | {{#fas:file-pdf}} [[File:Mohr2014.pdf]] | ||
[[Category:Vascular Pathology]] | |||
[[Category:Cerebral Vascular Malformations]] | |||
Latest revision as of 04:06, 20 July 2024
ARUBA Trial Summary
Objective
The ARUBA (A Randomized trial of Unruptured Brain Arteriovenous malformations) trial aimed to compare the risk of death and symptomatic stroke in patients with unruptured brain arteriovenous malformations (AVMs) managed with medical management alone versus medical management combined with interventional therapy (neurosurgery, embolization, or stereotactic radiotherapy).
Methods
- Design: Multicenter, non-blinded, randomized controlled trial.
- Participants: 226 adults with unruptured brain AVMs were enrolled from 39 clinical sites in nine countries.
- Randomization: Patients were randomized 1:1 to either medical management alone or medical management with interventional therapy.
- Outcome Measures: The primary outcome was time to death or symptomatic stroke.
Results
- Primary Endpoint: The trial was halted early due to the superiority of medical management alone. At a mean follow-up of 33.3 months, 11 patients (10.1%) in the medical management group reached the primary endpoint versus 35 patients (30.7%) in the interventional therapy group. The hazard ratio was 0.27 (95% CI 0.14–0.54).
- Adverse Events: Strokes and neurological deficits unrelated to stroke were significantly higher in the interventional therapy group.
Conclusion
Medical management alone was found to be superior to interventional therapy for the prevention of death or stroke in patients with unruptured brain AVMs over a mean follow-up of 33 months. These results suggest that medical management should be preferred, and the trial continues with an observational phase to assess long-term outcomes.
Criticism
- Grouping of various treatment modalities as one group
- Study was aborted after median F/U of only 33 m
- Selection bias: Majority of S-M I / II were not treated microsurgically despite being the treatment of choice
- Inclusion of high-grade AVM’s
- Most AVM’s were treated with embo’ alone
Reference
Mohr JP, Parides MK, Stapf C, et al. Medical management with or without interventional therapy for unruptured brain arteriovenous malformations (ARUBA): a multicentre, non-blinded, randomised trial. Lancet 2014; 383: 614–21. File:Mohr2014.pdf