However, investigators noted that balloon angioplasty might increase the short-term risk for periprocedural complications.
The findings suggest that balloon angioplasty plus aggressive medical management may be an effective treatment for sICAS, although the risk of stroke or death within 30 days of balloon angioplasty should be considered in clinical practice.
As many as 15.1% patients with sICAS experience recurrent stroke within a year despite aggressive medical management.
The randomized, open-label, blinded-endpoint BASIS trial included 501 patients with primary or recurrent sICAS (median age, 58 years; 69% men) at 31 stroke centers in China. Most patients (84.4%) had ischemic stroke, while 15.6% had transient ischemic attack.
articipants received aggressive medical management alone or combined with balloon angioplasty. The mean time from the ischemic event to randomization was about 33 days.
Aggressive medical management included 100-mg aspirin daily for the entire follow-up period and clopidogrel 75 mg daily for the first 90 days after enrollment. (Clopidogrel could be replaced with ticagrelor or cilostazol for patients with clopidogrel resistance.)
Vascular risk factor management included blood pressure goal at or below 140 mm Hg/90 mm Hg, target low-density lipoprotein cholesterol level (< 70 mg/dL), diabetes management (A1c < 7.0%), and lifestyle modification, including smoking cessation and physical activity.
The study recommended patients in the balloon angioplasty group undergo submaximal balloon angioplasty, defined as a balloon inflation diameter 50%-70% of the proximal artery diameter, with a dedicated intracranial balloon without stent implantation.
The primary study outcome was a composite of any stroke or death within 30 days of enrollment and any ischemic stroke in the territory of the qualifying artery or revascularization of the qualifying artery from 30 days through 12 months after enrollment.
The balloon angioplasty group reported a significantly lower rate of composite stroke or death within 30 days than the aggressive medical management group (4.4% vs 13.5%; hazard ratio [HR], 0.32; P < .001).
Looking at any stroke or all-cause death within 30 days of enrollment, investigators found a 3.2% vs 1.6% rate in the balloon angioplasty group vs aggressive medical management group (HR, 2.05; 95% CI, 0.62-6.81). Rates of any ischemic stroke in the qualifying artery territory from 30 days to 1 year were 0.4% with balloon angioplasty vs 7.5% with aggressive medical management, and revascularization of the qualifying artery occurred in 1.2% and 8.3%, respectively.
The authors acknowledged the risk for periprocedural composite primary outcome events was initially higher in the balloon angioplasty group, but the difference was not statistically significant.
The event rates later crossed at the 30-day point of the Kaplan-Meier curves.
Results for secondary outcomes showed the rates of any stroke or all-cause death within 30 days after enrollment were 3.2% and 1.6% in the balloon angioplasty and aggressive medical management groups, respectively (HR, 2.05; 95% CI, 0.62-6.81; P = .24).
Rates of other secondary outcomes were also lower in the balloon angioplasty group, including any stroke in the territory of the qualifying artery or all-cause death within 1 year, qualifying artery revascularization within 1 year, and combined vascular events (stroke, myocardial infarction, and vascular death) within 1 year.
Moreover, balloon angioplasty was associated with a shift in the distribution of 90-day and 1-year modified Rankin scale scores toward better outcomes than aggressive medical management alone.
A post hoc analysis showed that even after removing the revascularization component from the composite endpoint, the balloon angioplasty group still had significantly lower rates of the primary outcome than the aggressive medical management group (3.6% vs 9.1%; HR, 0.39; 95% CI, 0.18-0.85).
Rates of symptomatic intracranial hemorrhage (ICH) were 1.2% and 0.4% and those of asymptomatic ICH were 1.2% and 0% in the balloon angioplasty and aggressive medical management groups, respectively. Disabling stroke was lower in the balloon angioplasty group than in the aggressive medical management group (2.4% vs 7.1%).
In the balloon angioplasty group, procedural complications occurred in 17.4% patients and arterial dissection occurred in 14.5% patients.
The study didn't address the longer-term effect of balloon angioplasty revascularization and restenosis of the qualifying artery. Another limitation was that more than half of patients were from the lead center, although a post hoc analysis adjusting for center effect showed results were similar to the main analysis.
The study also didn't assess drug-coated balloons or drug-eluting stents for sICAS, and as it involved only Chinese patients, the findings may not be generalizable to other ethnic populations.
RU
EN