Balloon Angioplasty Plus Aggressive Medical Management Reduces Stroke Risk in Intracranial Artery Stenosis: BASIS Trial

"The findings indicate that combining balloon angioplasty with aggressive medical management could be an effective treatment for sICAS. However, stroke or death risk within 30 days following balloon angioplasty should be carefully considered in clinical practice," the researchers wrote in JAMA.

Intracranial artery stenosis is a condition where the arteries within the brain become narrowed, increasing the risk of stroke. Historically, medical management—often involving antiplatelet therapy and medications to control risk factors—has been the standard approach.

Previous randomized clinical trials have not shown that endovascular stenting is superior to aggressive medical management for patients with symptomatic intracranial atherosclerotic stenosis. However, balloon angioplasty has not been evaluated in a randomized clinical trial. Therefore, Xuan Sun, China National Clinical Research Center for Neurological Diseases, Beijing, China, and colleagues aimed to evaluate if combining balloon angioplasty with aggressive medical management offers superior outcomes compared to aggressive medical management alone for patients with sICAS.

For this purpose, the researchers conducted a randomized, open-label, blinded end-point clinical trial across 31 centers in China. The study recruited eligible patients aged 35 to 80 years with sICAS, defined as a recent transient ischemic attack (within 90 days) or ischemic stroke (14-90 days before enrollment), attributed to 70% to 99% atherosclerotic stenosis of a major intracranial artery. Patients had to be receiving treatment with at least one antithrombotic drug and/or standard risk factor management. Recruitment occurred between November 8, 2018, and April 2, 2022, with a final follow-up on April 3, 2023.

Participants were randomly assigned to either submaximal balloon angioplasty combined with aggressive medical management (n = 249) or aggressive medical management alone (n = 252). Aggressive medical management involved dual antiplatelet therapy for the initial 90 days and control of risk factors.

The primary outcome measures included a composite of any stroke or death within 30 days of enrollment or after balloon angioplasty of the qualifying lesion, as well as any ischemic stroke in the qualifying artery territory or revascularization of the qualifying artery from 30 days to 12 months after enrollment.

The study revealed the following findings:

• Among 512 randomized patients, 501 were confirmed eligible (mean age, 58.0 years; 31.5% were women) and completed the trial.
• The incidence of the primary outcome was lower in the balloon angioplasty group than in the medical management group (4.4% versus 13.5%; hazard ratio, 0.32).
• The respective rates of any stroke or all-cause death within 30 days were 3.2% and 1.6%.
• Beyond 30 days through 1 year after enrollment, the rates of any ischemic stroke in the qualifying artery territory were 0.4% and 7.5%, respectively, and revascularization of the qualifying artery occurred in 1.2% and 8.3%, respectively.
• The rate of symptomatic intracranial hemorrhage in the balloon angioplasty and medical management groups was 1.2% and 0.4%, respectively.
• In the balloon angioplasty group, procedural complications occurred in 17.4% of patients, and arterial dissection occurred in 14.5% of patients.

"In patients with sICAS, combining balloon angioplasty with aggressive medical management significantly reduced the risk of a composite outcome—including any stroke or death within 30 days, or an ischemic stroke or revascularization of the qualifying artery from 30 days to 12 months—compared to aggressive medical management alone," the researchers concluded.

Reference:

Sun X, Deng Y, Zhang Y, et al. Balloon Angioplasty vs Medical Management for Intracranial Artery Stenosis: The BASIS Randomized Clinical Trial. JAMA. Published online September 05, 2024. doi:10.1001/jama.2024.12829