A recent study published in JAMA Network suggests that balloon angioplasty combined with aggressive medical management may offer a superior treatment option for patients with severe symptomatic intracranial atherosclerotic stenosis (sICAS) compared to aggressive medical management alone. The randomized, open-label, blinded end point clinical trial, conducted across 31 centers in China, enrolled 501 patients aged 35 to 80 years with sICAS, defined as recent transient ischemic attack or ischemic stroke attributed to a 70% to 99% atherosclerotic stenosis of a major intracranial artery.
The trial compared submaximal balloon angioplasty plus aggressive medical management (n=249) to aggressive medical management alone (n=252). Aggressive medical management included dual antiplatelet therapy for the first 90 days and risk factor control. The primary outcome was a composite of any stroke or death within 30 days after enrollment or balloon angioplasty, or any ischemic stroke in the qualifying artery territory or revascularization of the qualifying artery after 30 days through 12 months after enrollment.
The results demonstrated a statistically significant reduction in the primary outcome in the balloon angioplasty group (4.4%) compared to the medical management group (13.5%) (hazard ratio, 0.32 [95% CI, 0.16-0.63]; P<.001). Specifically, the rates of any stroke or all-cause death within 30 days were 3.2% and 1.6% in the balloon angioplasty and medical management groups, respectively. Furthermore, beyond 30 days through 1 year, 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.
However, the study also reported a higher rate of symptomatic intracranial hemorrhage in the balloon angioplasty group (1.2%) compared to the medical management group (0.4%). Additionally, procedural complications occurred in 17.4% of patients in the balloon angioplasty group, with arterial dissection occurring in 14.5% of patients.
These findings suggest that while balloon angioplasty plus aggressive medical management may be an effective treatment for sICAS, the risk of stroke or death within 30 days of balloon angioplasty should be carefully considered in clinical practice. This study is notable as previous randomized clinical trials had not demonstrated the superiority of endovascular stenting over aggressive medical management for sICAS. Balloon angioplasty had not been previously investigated in a randomized clinical trial setting for this condition. The trial was registered at ClinicalTrials.gov (NCT03703635).
