BASIS
Trial question
What is the role of balloon angioplasty plus aggressive medical management in patients with symptomatic intracranial atherosclerotic stenosis?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
32.0% female
68.0% male
N = 501
501 patients (158 female, 343 male).
Inclusion criteria: patients aged 35-80 years with symptomatic intracranial atherosclerotic stenosis.
Key exclusion criteria: received thrombolytic therapy within 24 hours before enrolment; worsening neurological deficits within 24 hours before enrolment; other intracranial arteries with severe stenosis; stenosis > 50% of the parent artery to the qualifying artery; perforator stroke; baseline mRS score ≥ 3.
Interventions
N=249 balloon angioplasty plus aggressive medical management (balloon angioplasty plus risk factor management, including dual antiplatelet therapy for 90 days and aspirin daily thereafter).
N=252 aggressive medical management only (risk factor management, including dual antiplatelet therapy for 90 days and aspirin daily thereafter).
Primary outcome
Rate of stroke or death within 30 days or any ischemic stroke or revascularization of the qualifying artery beyond 30 days
4.4%
13.5%
13.5 %
10.1 %
6.8 %
3.4 %
0.0 %
Balloon angioplasty plus aggressive medical
management
Aggressive medical management
only
Significant
decrease ▼
NNT = 10
Significant decrease in the rate of stroke or death within 30 days or any ischemic stroke or revascularization of the qualifying artery beyond 30 days (4.4% vs. 13.5%; HR 0.32, 95% CI 0.16 to 0.63).
Secondary outcomes
No significant difference in the rate of any stroke or all-cause death within 30 days (3.2% vs. 1.6%; HR 2.05, 95% CI 0.62 to 6.81).
No significant difference in the rate of any stroke in the territory of the qualifying artery or all-cause death within 90 days (2.8% vs. 4%; HR 0.72, 95% CI 0.27 to 1.88).
Significant decrease in the rate of revascularization of the qualifying artery within 1 year (1.6% vs. 9.5%; HR 0.16, 95% CI 0.06 to 0.47).
Safety outcomes
No significant difference in procedural complications.
Significant difference in disabling stroke (2.4% vs. 7.1%).
Conclusion
In patients aged 35-80 years with symptomatic intracranial atherosclerotic stenosis, balloon angioplasty plus aggressive medical management was superior to aggressive medical management only with respect to the rate of stroke or death within 30 days or any ischemic stroke or revascularization of the qualifying artery beyond 30 days.
Reference
Xuan Sun, Yiming Deng, Yong Zhang et al. Balloon Angioplasty vs Medical Management for Intracranial Artery Stenosis: The BASIS Randomized Clinical Trial. JAMA. 2024 Oct 1;332(13):1059-1069.
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