Comparison of Drug-Coated Balloons to Bare Metal Stents in the Treatment of Symptomatic Vertebral Artery-Origin Stenosis: A Prospective Randomized Trial

Abstract

We sought to compare the angiographic and clinical outcomes of drug-coated balloon (DCB) with distal embolic protection devices (EPDs) versus bare metal stent (BMS) without EPD in the treatment of symptomatic vertebral artery origin stenosis (VAOS). Between January 2017 and December 2018, a prospective randomized trial was conducted involving 95 patients with symptomatic VAOS randomly assigned to treatment with DCB+ EPD (n= 49) or BMS without EPD (n= 46). Target vessel restenosis (RS) >50% detected by computed tomography angiography was the primary endpoint. Technical success, clinical success, and signal intensity abnormalities on diffusion-weighted imaging within 3 days after operation were compared. The 30-day technical success rate was 93.9% for DCB group versus 95.7% for the BMS group (P= 0.094). Diffusion-weighted imaging within 3 days postoperative showed asymptomatic embolization in 2 (4.1%) patients in the DCB group and 9 (19.6%) patients in the BMS group (P= 0.004). At a mean 16-month follow-up, the clinical success rate was 89.8% for the DCB group versus 91.3% (42/46) for the BMS group (P= 0.125). The RS was seen in 5/49 (10.2%) in the DCB group and 6/46 (13.0%) in the BMS group (P= 0.082). Target vessel revascularization was performed in 4 (8.7%) BMS group versus 3 (6.1%) in the DCB group (P= 0.091). DCB with EPD in the treatment of symptomatic VAOS is technically feasible and safe and significantly reduced thromboembolic events on imaging when compared with BMS without EPD. There was no significant difference between the 2 groups in the rate of RS during 12 months after surgery.