椎动脉开口部位专用支架发生再狭窄的原因初探
A preliminary study on causes of in-stent restenosis after vertebral artery ostium stenting
魏东升 1陈莹 2李冬婷 2唐锋 3李雷3
作者信息
- 1. 通辽市医院 介入血管外科,内蒙古 通辽 028000
- 2. 深圳信立泰医疗器械股份有限公司,广东 深圳 518118
- 3. 清华大学第一附属医院 血管外科,北京 100016
- 折叠
摘要
目的 探索椎动脉开口部位专用支架(Maurora支架)发生支架内再狭窄的原因,为临床规范化标准化治疗椎动脉开口狭窄提供临床证据.方法 收集 2021 年使用Maurora支架后的不良事件监测报告,对符合纳入标准经过 1 年随访的 644 例病例(661 处病变)进行回顾性分析.结果 共使用 665 枚支架,植入成功率为 99.7%(663/665).支架植入术后症状复发率为 7.6%(49/644),再狭窄率为 5.6%(37/661),其中症状性再狭窄率为 2.0%(13/661);支架断裂率为 6.3%(42/665),其中 2 例支架断裂导致再狭窄.慢性病风险因素、支架选择及残余狭窄、病变情况如狭窄情况、呼吸打折、扭曲成角及病变钙化在再狭窄原因中的权重较大.术后残余狭窄>10%患者在支架再狭窄组中显著增加(P= 0.020).再狭窄与支架直径(95%CI=0.54～5.22,P=0.372)和长度(95%CI=0.89～1.16,P=0.872)均无相关性.支架长度与支架断裂呈正线性相关(P=0.002).分组分析显示,病变情况结合选型操作与慢性病危险因素相比,更可能导致症状性再狭窄(P=0.020).结论 Maurora支架上市后临床效果不劣于上市前研究,症状复发及再狭窄发生率低于既往非专用支架时期临床经验.
Abstract
Objective To explorer the predictors of in-stent restenosis following Maurora vertebral artery ostium stent implant,and to provide clinical evidence for standardized clinical treatment of vertebral artery ostial stenosis.Methods Adverse event surveillance reports after using the Maurora stent in 2021 were collected.The clinical data of 644 cases(661 lesions)who met the inclusion criteria and followed-up for 1 year were analyzed retrospectively.Results A total of 665 stents were used,and the implantation success rate was 99.7%(663/665).The symptom recurrence rate after stent implantation was 7.6%(49/644),and the restenosis rate was 5.6%(37/661),with a symptomatic restenosis rate of 2.0%(13/661).Stent rupture rate was 6.3%(42/665,with two instances of stent fracture leading to symptom.Chronic disease risk factors,stent selection,residual stenosis,as well as pathological conditions such as stenosis,respiratory tortuosity,tortuosity,and calcification of lesions,played significant roles in the etiology of restenosis.Patients with postoperative residual stenosis>10%were significantly increased in the stent restenosis group(P=0.020).There was no correlation between restenosis and stent diameter(95%CI=0.54-5.22,P=0.372)or length(95%CI=0.89-1.16,P=0.872).There was a positive linear correlation between stent length and stent fracture(P=0.002).Group analysis showed that lesion conditions combined with selection procedures were more likely to cause symptomatic restenosis than chronic disease risk factors(P=0.020).Conclusion The clinical effect of Maurora stent for the vertebral artery opening is not inferior to that of pre-market studies,and the incidence of symptom recurrence and restenosis is lower than the previous clinical experience in the non-dedicated stent period.
关键词
椎动脉/药物洗脱支架/支架内再狭窄Key words
Vertebral artery/Drug-eluting stent/In-stent restenosis引用本文复制引用
基金项目
北京市卫生健康委卫生科技成果和适宜技术推广项目(BHTPP2022093)
北京华信医院领航基金(2022-LH-07)
出版年
2024
NETL
NSTL
维普
万方数据