A Randomized Trial of Unruptured Brain AVMs (ARUBA)

Columbia University

Status and phase: Completed; Phase 3

Conditions: Arteriovenous Malformations, Cerebral

Treatments: Procedure: Interventional therapy; Other: Medical management

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00389181

U01NS051483 (U.S. NIH Grant/Contract)

AAAB6286

U01NS051566 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to determine if medical management is better than invasive therapy for improving the long-term outcome of patients with unruptured brain arteriovenous malformations.

Full description

Brain arteriovenous malformations (BAVMs) are an infrequent but important cause of stroke, particularly in a young population. Current invasive treatment strategies are varied and include endovascular procedures, neurosurgery, and radiotherapy. All of these treatments are administered on the assumption that they can be achieved at acceptably minor complication rates, decrease the risk of subsequent hemorrhage, and lead to better long-term outcomes.

Recent data from the literature comparing initial presentation and outcome for patients with ruptured and unruptured BAVMs have raised the possibility that such elective invasive treatment for unruptured BAVMs may yield worse outcomes than managing patients symptomatically with therapy. Unfortunately, no controlled clinical trials have yet been undertaken for management of unruptured BAVMs to address these concerns. Therefore, the goal of this randomized controlled trial is to determine if the long-term outcomes of patients who receive medical management for symptoms (e.g., headache, seizures) associated with an unruptured BAVM are superior to those who receive medical management and invasive therapy to eradicate the BAVM.

Participants will be randomly assigned to receive either symptomatic medical management alone or such management with invasive therapies (any combination of surgery, endovascular embolization, or radiotherapy). Functional assessment will be carried out at the time of randomization, pre-intervention and 48-hour post-intervention, and for all participants at 1 month, and at 6 month intervals throughout the follow up period which will be a minimum of 5 years.

Enrollment: 226 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient must have unruptured BAVM diagnosed by MRI/MRA, CTA and/or angiogram
2. Patient must be 18 years of age or older
3. Patient must have signed Informed Consent, Release of Medical Information, and Health Insurance Portability and Accountability Act (HIPAA/U.S. only) Forms

Exclusion criteria

1. Patient has BAVM presenting with evidence of recent or prior hemorrhage

2. Patient has received prior BAVM therapy (endovascular, surgical, radiotherapy)

3. Patient has BAVM deemed untreatable by local team, or has concomitant vascular or brain disease that interferes with/or contraindicates any interventional therapy type (stenosis/occlusion of neck artery, prior brain surgery/radiation for other reasons)

4. Patient has baseline Rankin ≥2

5. Patient has concomitant disease reducing life expectancy to less than 10 years

6. Patient has thrombocytopenia (< 100,000/μL),

7. Patient has uncorrectable coagulopathy (INR>1.5)

8. Patient is pregnant or lactating

9. Patient has known allergy against iodine contrast agents

10. Patient has multiple-foci BAVMs

11. Patient has any form of arteriovenous or spinal fistulas

    Previous diagnosis of any of the following -

12. Patient has a diagnosed Vein of Galen type malformation

13. Patient has a diagnosed cavernous malformation

14. Patient has a diagnosed dural arteriovenous fistula

15. Patient has a diagnosed venous malformation

16. Patient has a diagnosed neurocutaneous syndrome such as cerebro-retinal angiomatosis (von Hippel-Lindau), encephalo-trigeminal syndrome (Sturge-Weber), or Wyburn-Mason syndrome

17. Patient has diagnosed BAVMs in context of moya-moya-type changes

18. Patient has diagnosed hereditary hemorrhagic telangiectasia (Rendu-Osler-Weber)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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226 participants in 2 patient groups

Medical management

Experimental group

Description:

Patients with unruptured BAVMs will receive symptomatic medical management alone.

Treatment:

Other: Medical management

Interventional therapy

Active Comparator group

Description:

Patients with unruptured BAVMs will receive symptomatic medical management with invasive therapies (any combination of surgery, endovascular embolization, or radiotherapy).

Treatment:

Other: Medical management

Procedure: Interventional therapy