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Self-expanding stent with embolic protection strategy performs well in atherosclerotic vertebral artery ostial stenosis
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Besides demonstrating safety and feasibility, self-expanding stents with embolic protection devices reduced thromboembolic events among patients with symptomatic atherosclerotic vertebral artery ostial stenosis compared with balloon-expandable stents without an embolic protection device.
The prospective, randomized trial included 127 patients (mean age, 67.3 ± 10.2 years; 74% men) with symptomatic atherosclerotic vertebral artery ostial stenosis enrolled from July 2011 to March 2013. Patients were randomly assigned to treatment with self-expanding stents (Precise RX [Cordis] or RX Acculink [Abbott Vascular]) with embolic protection devices (Spider FX [Medtronic/Covidien]; n = 61) or balloon-expandable stents (Palmaz Blue [Cordis] or Resolute RX [Medtronic]; n = 66) without embolic protection devices.
The primary outcome measure was in-stent restenosis (ISR) greater than 50% via duplex ultrasound. Researchers also evaluated technical success, clinical success, complications within 30 days and signal intensity abnormalities on diffusion-weighted imaging (DWI) after stenting.
At 24 hours after the procedure, DWI indicated a higher rate of hyperintense lesions in the balloon-expandable stent arm (18.6% vs. 3.3%; P < .01)
Results at 30 days indicated a technical success rate of 95.5% in the self-expanding stent/embolic protection device arm vs. 100% in the balloon-expandable stent arm (P = .072). The two arms also had a comparable clinical success rate at 18 months (self-expanding stent/embolic protection device, 93.9% vs. balloon-expandable stent, 85.7%; P = .115).
Additional data revealed higher rates of ISR (22.9% vs. 3.1%; P < .01) and target vessel revascularization (10% vs. 0%; P < .01) in the balloon-expandable stent arm.
“Our study provides a unique insight into [vertebral artery ostial stenosis] treatment given the relatively large sample size,” the researchers wrote, adding that the data suggest that self-expanding stents with embolic protection devices are technically feasible and safe, and lower the rate of restenosis vs. balloon-expandable stents alone. “We encourage further multicenter prospective trials to validate our findings.” – by Brian Ellis
Disclosure: The researchers report no relevant financial disclosures.
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