Balloon Angioplasty vs Medical Management for Intracranial Artery Stenosis
Quick Takes
- Stenting of symptomatic intracranial atherosclerosis for secondary stroke prevention fell out of favor after the negative SAMMPRIS (stenting vs. medical therapy) trial results in 2011, but angioplasty versus medical management has not been studied in a large RCT.
- The BASIS trial was conducted in China and randomized patients with symptomatic intracranial atherosclerosis to either balloon angioplasty plus medical management versus medical management alone.
- Patients who underwent balloon angioplasty plus medical management did better than patients who underwent medical management alone. These results will likely need to be replicated in a US or multinational population before widespread adoption of angioplasty for secondary stroke prevention in the setting of symptomatic intracranial atherosclerosis in the US.
Study Questions:
Is balloon angioplasty plus medical management superior to medical management alone in patients with symptomatic intracranial atherosclerotic stenosis?
Methods:
This was an open-label Chinese trial with 1:1 randomization and blinded endpoint assessment. Eligible patients were 35-80 years old and had a recent transient ischemic attack or ischemic stroke within 90 days of enrollment with a relevant 70-99% intracranial atherosclerotic stenosis. Medical management consisted of 90 days of dual antiplatelet therapy and other risk factor (e.g., diabetes, cholesterol) modification. Balloon angioplasty was performed under general anesthesia and consisted of balloon inflation of the stenosed vessel to 50-70% of the proximal (non-stenosed) artery diameter. The primary outcome was a composite of 1) any stroke (including symptomatic intracranial hemorrhage) or death within 30 days after enrollment or angioplasty, 2) any ischemic stroke in the qualifying artery territory, or 3) acute or elective revascularization of the qualifying artery after 30 days through 12 months following enrollment.
Results:
In the primary analysis, there were 249 patients in the angioplasty group and 252 in the medical management group. Median age was 58 years in both groups. The angioplasty group did better with a 4.4% risk of the primary outcome compared to 13.5% in the medical management group (hazard ratio [HR], 0.32; 95% confidence interval [CI], 0.16-0.63). The angioplasty group had a lower risk of combined vascular events (stroke, myocardial infarction, vascular death) within 1 year (4% compared to 10.3%; HR, 0.38; 95% CI, 0.19-0.80). 14.5% of patients who underwent angioplasty had an arterial dissection; 71.4% of patients with dissection underwent rescue stenting.
Conclusions:
Balloon angioplasty plus medical management may be an effective treatment for symptomatic intracranial atherosclerotic stenosis.
Perspective:
BASIS is the first randomized clinical trial (RCT) whose results support a nonmedical approach to the treatment of symptomatic intracranial atherosclerotic stenosis. Acute or elective revascularization of the qualifying artery after 30 days through 12 months following enrollment is an unusual endpoint in a stroke clinical trial, but even with removal of the revascularization events from the composite primary outcome, the patients in the angioplasty group did better than the patients in the medical management group. It should be noted that >85% of patients in the medical management arm did not have a recurrent ischemic event or require revascularization at 1 year, results which may make deferral of angioplasty an attractive option for some patients, particularly those at higher procedural risk. The positive results of BASIS will likely need to be replicated in a US or multinational population before widespread adoption of angioplasty for secondary stroke prevention in the setting of symptomatic intracranial atherosclerosis for most patients in the US. However, it is likely that at many centers, angioplasty will begin to be entertained as an option for patients with recurrent cerebral ischemia secondary to intracranial atherosclerotic stenosis.
Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Prevention, Vascular Medicine, Interventions and Vascular Medicine
Keywords: Angioplasty, Balloon, Intracranial Arterial Diseases, Stenosis, Secondary Prevention
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