Abstract
Background and Purpose: Drug-eluting stents generally have superior performance to bare metal stents in the treatment of vertebral artery stenosis (VAS). This prospective, multicenter, and single-arm clinical trial was initiated to assess in-stent restenosis (ISR) and midterm outcome after rapamycin-eluting stent placement in patients with symptomatic extracranial VAS.Methods: The subjects underwent angiographic follow-up at 6 months and final clinical follow-up at 12 months. The primary efficacy endpoint was ISR at 6 months. Secondary endpoints included technical success, target lesion-related transient ischemic attack (TIA), stroke, or death, and all-cause TIA, stroke, or death during the 12-month follow-up period.Results: A total of 104 stents were implanted in the 101 patients and 83 patients (82.2%) completed angiographic follow-up at 6 months. The technical success rate was 86.1% (87/101); mean in-stent stenosis rate was 25.1 ± 17.1% and ISR rate was 5.9% (95% CI: 0.8–10.9%). All the patients with ISR were completely asymptomatic and no stent fractures were observed during angiographic follow-up. At the 12-month clinical follow-up, target lesion-related TIA, stroke, or death had occurred in two (2.0%) patients and all-cause TIA, stroke, or death had occurred in six (6.1%) patients.Conclusion: The placement of rapamycin-eluting stents in patients with symptomatic extracranial VAS yields favorable ISR results and showed a trend of favorable safety outcomes including low rates of perioperative complications and late stroke. However, further study is needed to establish the long-term clinical benefits of this stent in the treatment of VA disease.
Highlights
Despite the promising results achieved with endovascular stenting, high rates of in-stent restenosis (ISR) ranging from 11.1 to 66.7% have been reported [5, 8,9,10], which is mainly caused by neointimal hyperplasia
We investigated the applicability of rapamycin-eluting stents to the treatment of symptomatic extracranial vertebral artery stenosis (VAS)
Between July 7, 2014, and November 26, 2015, a total of 101 patients were enrolled in the trial and 104 stents [102 drug-eluting stents (DESs) and 2 bare metal stent (BMS) (Apollo, MicroPort Scientific, Shanghai, China)]
Summary
Posterior circulation strokes are associated with high morbidity and mortality rates and account for approximately 20% of all the ischemic strokes, with up to 20% of cases involving vertebral artery stenosis (VAS) [1]. Despite the promising results achieved with endovascular stenting, high rates of in-stent restenosis (ISR) ranging from 11.1 to 66.7% have been reported [5, 8,9,10], which is mainly caused by neointimal hyperplasia. To overcome this problem, drug-eluting stents (DESs) were developed for the treatment of severe coronary artery stenosis. DESs have shown promising results in the treatment of cerebrovascular stenosis Most of these studies were case reports or case series and there are limited comparative data on the efficacy of rapamycin- and paclitaxeleluting stents in the treatment of VAS. This prospective, multicenter, and single-arm clinical trial was initiated to assess in-stent restenosis (ISR) and midterm outcome after rapamycin-eluting stent placement in patients with symptomatic extracranial VAS
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