雷帕霉素洗脱支架与金属裸支架治疗症状性颅内动脉粥样硬化性狭窄的效果比较

doi:10.3969/j.issn.1673-5765.2022.05.015

摘要/Abstract

摘要：

目的观察研究雷帕霉素洗脱支架（rapamycin-eluting stent，RES）与金属裸支架（bare-metal stent， BMS）治疗症状性颅内动脉粥样硬化性狭窄（symptomatic intracranial atherosclerotic stenosis，ICAS）的临床疗效。

方法回顾性收集2015年7月-2019年12月青岛大学附属医院连续收治的行球囊扩张支架置入术治疗症状性ICAS患者的临床资料。根据术中所选支架类型分为RES治疗组和BMS治疗组，比较2组的基线资料、技术成功（血管残余狭窄＜30%）率、术后7 d内并发症（包括血管破裂、夹层、支架内血栓、卒中、TIA、脑出血、蛛网膜下腔出血等）发生率、1年支架内再狭窄（狭窄率＞50%）率的差异。

结果共纳入116例患者，平均年龄60.4±8.2岁，男性75例（64.7%），其中RES治疗组46例，BMS治疗组70例。2组的基线资料、技术成功率、术后7 d并发症发生率差异无统计学意义；RES治疗组的1年支架内再狭窄率为0，低于BMS治疗组的20.0%，差异具有统计学意义（P＝0.012）。

结论 RES在治疗症状性ICAS患者方面具有与现有的BMS相同的安全性，且较BMS有更低的1年支架内再狭窄率。

文章导读： 目前DES用于脑血管狭窄的研究较少，本研究通过对比RES和BMS治疗ICAS的有效性和安全性，发现RES术后1年支架内再狭窄率显著低于BMS，手术成功率和安全性与BMS相似，为RES在脑血管病介入治疗中的临床应用提供了一定依据。

关键词: 雷帕霉素药物洗脱支架; 颅内动脉粥样硬化性狭窄; 缺血性卒中; 支架内再狭窄

Abstract: Objective To observe the clinical efficacy and safety of rapamycin-eluting stent (RES) and baremetal stent (BMS) in treatment of symptomatic intracranial atherosclerotic stenosis (ICAS). Methods This retrospective study enrolled the patients with symptomatic ICAS who were treated with balloon expandable stents in the Affiliated Hospital of Qingdao University from July 2015 to December 2019. The patients were divided into RES group and BMS group. The baseline data, technical success (residual stenosis<30%) rate, complications (including vascular rupture, arterial dissection, in-stent thrombosis, stroke, transient ischemic attack, cerebral hemorrhage, subarachnoid hemorrhage, etc.) rate within 7 days and 1-year in-stent restenosis (stenois>50%) rate were compared between the two groups. Results A total of 116 patients were enrolled in this study, with a mean age of 60.4±8.2 years and 75 males (64.7%), 46 cases in RES group and 70 cases in BMS group. There were no statistical differences in the baseline data, technical success rate and complications rate within 7 days between the two groups. The incidence of 1-year in-stent restenosis in RES group was lower than that in BMS group (0 vs . 20.0%, P =0.012). Conclusions RES has the same safety as the existing BMS in treatment of symptomatic ICAS, and it has a lower 1-year in-stent restenosis rate than BMS.

Key words: Rapamycin-eluting stent; Intracranial atherosclerotic stenosis; Ischemic stroke; Instent restenosis

凌一童, 孙玉杰, 李广文, 刘彤晖, 李野, 张勇. 雷帕霉素洗脱支架与金属裸支架治疗症状性颅内动脉粥样硬化性狭窄的效果比较[J]. 中国卒中杂志, 2022, 17(05): 529-534.

LING Yitong, SUN Yujie, LI Guangwen, LIU Tonghui, LI Ye, ZHANG Yong. Comparison of Rapamycin-Eluting Stent with Bare-Metal Stent in Patients with Symptomatic IntracranialAtherosclerotic Stenosis[J]. Chinese Journal of Stroke, 2022, 17(05): 529-534.

参考文献

[1] JUNG J M，KANG D W，YU K H，et al. Predictors of recurrent stroke in patients with symptomatic intracranial arterial stenosis[J]. Stroke，2012，43（10）：2785-2787.
[2] WANG Y，MENG R，LIU G，et al. Intracranial atherosclerotic disease[J/OL]. Neurobiol Dis，2019，124：118-132[2021-12-16]. https://doi.org/10.1016/j.nbd.2018.11.008.
[3] HAFEEZ A，LIU L，DING Y C. Ongoing progress and new developments in the clinical approach to stroke and cerebrovascular disease：new paradigms：a novel outlook into stroke[J/OL]. Neurol Res，2016，38（6）：477[2021-10-16]. https://doi.org/10.1080/01616412.2016.1192264.
[4] WANG Y J，ZHAO X Q，LIU L P，et al. Prevalence and outcomes of symptomatic intracranial large artery stenoses and occlusions in China：the Chinese intracranial atherosclerosis（CICAS）study[J]. Stroke，2014，45（3）：663-669.

[5] A K E TA S，WAJ IMA D，KISHI M，e tal . Endovascular therapy for the steal phenomenon due to the innominate artery severe stenosis and bilateral internal carotid artery severe stenosis[J/OL]. World Neurosurg，2017，105：1040-1041[2021-12-16].https://doi.org/10.1016/j.wneu.2017.06.154.

[6] BANGALORE S，KUMAR S，FUSARO M，et al. Short- and long-term outcomes with drug-eluting and bare-metal coronary stents：a mixed-treatment comparison analysis of 117 762 patient-years of follow-up from randomized trials[J]. Circulation，2012，125（23）：2873-2891.
[7] SECEMSKY E A，KUNDI H，WEINBERG I，et al. Drug-eluting stent implantation and long-term survival following peripheral artery revascularization[J]. J Am Coll Cardiol，2019，73（20）：2636-2638.
[8] CHIMOWITZ M I，LYNN M J，HOWLETT-SMITH H，et al. Comparison of warfarin and aspirin for symptomatic intracranial arterial stenosis[J]. N Engl J Med，2005，352（13）：1305-1316.
[9] J IN M，FU X，WEI Y Z，et al. Higher risk of recur rent ischemic events in patients with intracranial in-stent restenosis[J]. Stroke，2013，44（11）：2990-2994.
[10] 余莹，娄亚柯，崔荣荣，等. 颅内动脉支架内再狭窄
的研究进展[J]. 中国卒中杂志，2021，16（6）：619-624.
[11] KANG K J，ZHANG Y，SHUAI J，et al. Balloonmounted stenting for ICAS in a multicenter registry study in China：a comparison with the WEAVE/WOVEN trial[J]. J Neurointerv Surg，2021，13（10）：894-899.
[12] JIA B X，ZHANG X L，MA N，et al. Comparison of drug-eluting stent with bare-metal stent in patients with symptomatic high-grade intracranial atherosclerotic stenosis：a randomized clinical trial[J]. JAMA Neurol，2022，79（2）：176-184.
[13] ZHANG Y J，CHEN F，MURAMATSU T，et al. Nine-month angiographic and two-year clinical follow-up of polymer-free sirolimus-eluting stent versus durable-polymer sirolimus-eluting stent for coronary artery disease：the Nano randomized trial[J]. Chin Med J（Engl），2014，127（11）：2153-2158.
[14] QURESHI A I，KIRMANI J F，HUSSEIN H M，et al. Early and intermediate-term outcomes with drugeluting stents in high-risk patients with symptomatic intracranial stenosis[J]. Neurosurgery，2006，59（5）：1044-1051.
[15] LU H T，ZHENG P，ZHANG W C. Long-term outcome of drug-eluting stenting for stenoses of the intracranial vertebrobasilar artery and vertebral ostium[J]. J Neurointerv Surg，2013，5（5）：435-439.

[16] KURRE W，AGUILAR-PÉREZ，M，FISCHER S，et al. Solving the issue of restenosis after stenting of intracranial stenoses：experience with two thinstrut drug-eluting stents（DES）-taxus element and resolute integrity[J]. Cardiovasc Intervent Radiol，2015，38（3）：583-591.
[17] LEVY E I，HANEL R A，TIO F O，et al. Safety and pharmacokinetics of sirolimus-eluting stents in the canine cerebral vasculature：180 day assessment[J]. Neurosurgery，2006，59（4）：925-933，933-934.
[18] KIM J，BAN S P，KIM Y D，et al. Long-term outcomes of drug-eluting stent implantation in patients with symptomatic extra- and intracranial atherosclerotic stenoses[J]. J Cerebrovasc Endovasc Neurosurg，2020，22（4）：216-224.
[19] HASSAN A E，MOHAMMADEN M H，RABAH R R，et al. Init ial exper ience wit h the nextgeneration resolute onyx zotarolimus-eluting stent in symptomatic intracranial atherosclerotic disease[J/OL]. Front Neurol，2020，11：570100[2021-12-16]. https://doi.org/10.3389/fneur.2020.570100.
[20] BARNARD Z R，ALEXANDER M J. Update in the treatment of intracranial atherosclerotic disease[J]. Stroke Vasc Neurol，2020，5（1）：59-64.
[21] YE G F，YIN X L，YANG X M，et al. Efficacy and safety of drug-eluting stent for the intracranial atherosclerot ic disease：a systemat ic review and meta-analysis[J/OL]. J Clin Neurosci，2019，59：112-118[2021-12-16]. https://doi.org/10.1016/j.jocn.2018.10.118.