Skip to main content

Journal Club

Cerebrovascular

Medical management with or without interventional therapy for unruptured brain arteriovenous malformations (ARUBA): a multicentre, non-blinded, randomised trial

Lancet | 2014

Rapid review note

Journal Club is a rapid, AI-assisted appraisal layer. It highlights study design, effect estimates, and practice relevance, but it is still a briefing, not a replacement for the paper.

For education only. Not medical advice.

Paper snapshot

Rapid study overview

Open paper

DOI

10.1016/S0140-6736(13)62302-8

PMID

24268105

PICO

Population

Adult patients (≥18 years) with an unruptured brain arteriovenous malformation

Intervention

Medical management with interventional therapy (neurosurgery, embolisation, or stereotactic radiotherapy, alone or in combination)

Comparator

Medical management alone (pharmacological therapy for neurological symptoms as needed)

Outcomes

Time to death or symptomatic stroke; secondary outcomes include stroke counts and neurological deficits

Design

Type

Randomised controlled trial

Randomized

Yes

Multicenter

Yes

Blinded

No blinding (non-blinded)

Follow-up

Mean 33.3 months (SD 19.7)

Primary endpoint

Time to composite endpoint of death or symptomatic stroke

Secondary endpoints

  • Number of strokes
  • Neurological deficits unrelated to stroke

Practice impact

What this means

ARUBA randomized 223 adults with unruptured brain AVMs to medical management alone versus medical management plus intervention (surgery, embolization, or radiotherapy). At mean 33-month follow-up, the intervention group had significantly higher rates of death or stroke (30.7% vs 10.1%, HR 0.27). This challenges the practice of preventive intervention for unruptured AVMs, though longer-term data are needed.

Bottom line

For unruptured brain AVMs, medical management alone resulted in significantly lower risk of death or stroke compared to interventional therapy over 33 months

Strength of evidence

moderate

Recommendation

consider change

Why it matters

  • Randomized trial showing clear harm from intervention in short-term
  • Lack of blinding and early stopping limit certainty
  • Need longer-term data from observational phase

What would change my mind

  • Long-term follow-up showing reversal of benefit
  • Subgroup analysis identifying patients who benefit from intervention
  • Higher-quality trial with blinding and longer follow-up

Critical appraisal

How strong is the paper?

Methods critique

Risk of bias

High risk from lack of blinding; patients, clinicians, and investigators aware of treatment assignment

Confounding

Randomization stratified by clinical site with permuted blocks; intention-to-treat analysis used

Missing data

Not applicable: primary analysis included all 223 randomized patients with outcome data

Multiplicity

Single primary endpoint with prespecified stopping boundary; secondary outcomes reported with p-values

Notes

  • Trial stopped early for superiority of medical management group
  • Observational phase ongoing for additional follow-up

Stats check

NNT

Not reported

Effect sizes

  • HR 0.27 (95% CI 0.14-0.54)
  • log-rank Z statistic 4.10

Absolute effects

  • Primary endpoint reached by 11/109 (10.1%) in medical management vs 35/114 (30.7%) in interventional therapy
  • 45 strokes in interventional therapy vs 12 in medical management (p<0.0001)

Concerns

  • Early stopping may overestimate treatment effect
  • Mean follow-up only 33 months

External validity

Who it applies to

Adults with unruptured brain AVMs considered for preventive intervention

Who it does not

Patients with ruptured AVMs, pediatric patients, or those with specific high-risk features not captured in trial

Generalizability notes

  • 39 clinical sites across 9 countries
  • Includes various interventional modalities (surgery, embolization, radiotherapy)

Evidence trace

Source trace and metadata

Citations (3)

claim_id

methods_critique.risk_of_bias

locator

p. 2 Methods

quote

Patients, clinicians, and investigators are aware of treatment assignment.

claim_id

stats_check.effect_sizes

locator

p. 4 Results

quote

The risk of death or stroke was significantly lower in the medical management group than in the interventional therapy group (hazard ratio 0·27, 95% CI 0·14-0·54).

claim_id

practice_impact.bottom_line

locator

p. 5 Discussion

quote

The ARUBA trial showed that medical management alone is superior to medical management with interventional therapy for the prevention of death or stroke in patients with unruptured brain arteriovenous malformations followed up for 33 mon...

Metadata

Generated at

2026-03-06T13:41:29.251Z

Version

top 100 cited in past 20 years