The BASIS trial conducted in China has demonstrated that submaximal balloon angioplasty for symptomatic intracranial atherosclerotic stenosis (ICAS) leads to improved outcomes compared to aggressive medical management alone.
The study, published in *JAMA*, revealed that the incidence of a composite outcome—comprising any stroke or death within 30 days, or any ischemic stroke or revascularization of the affected artery from 30 days to 12 months—was significantly lower with balloon angioplasty compared to medical management alone (4.4% vs. 13.5%; HR 0.32, 95% CI 0.16-0.63, P<0.001). Even when excluding the less severe endpoint of revascularization, balloon angioplasty still showed a benefit (3.6% vs. 9.1%; HR 0.39, 95% CI 0.18-0.85), according to Dr. Zhongrong Miao and colleagues from Beijing Tiantan Hospital.
In an accompanying editorial, Dr. Tanya Turan and Dr. Colin Derdeyn acknowledged that while the study has limitations, it provides important proof-of-concept evidence suggesting that endovascular treatments could effectively reduce stroke risk in ICAS. They noted that previous trials of percutaneous angioplasty and stenting faced challenges due to high rates of periprocedural complications, such as ischemic stroke and brain hemorrhage.
The BASIS trial involved 512 adults aged 35 to 80 from 31 centers across China, who had experienced an ischemic stroke or transient ischemic attack (TIA) within the past 90 days due to severe ICAS (70% to 99% stenosis) and were on at least one antithrombotic medication or standard risk factor management.
As reported by medpagetoday.com, the study’s balloon angioplasty group received a procedure using a dedicated intracranial balloon under general anesthesia, with the balloon inflated to 50% to 70% of the proximal artery diameter. While the procedure showed reduced rates of ischemic stroke in the qualifying artery territory and fewer revascularizations over 12 months, it was associated with some early complications: 3.2% of patients in the balloon angioplasty group experienced any stroke or death within 30 days, compared to 1.6% in the medical management group. Additionally, procedural complications, including arterial dissection and symptomatic intracranial hemorrhage, were noted.
The editorialists also pointed out potential biases in the study design, such as the exclusion of patients with ischemic stroke within the first two weeks post-event to reduce periprocedural risks and the uneven enrollment across participating centers. They highlighted that the lower event rates at the main center, which had a higher volume of cases, suggest that the experience of neurointerventionists and clinical sites might influence the outcomes.
They called for further research comparing angioplasty with medical therapy in diverse populations, emphasizing the need for additional studies before considering angioplasty as a widespread alternative treatment for ICAS.