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第二代永久性和可生物降解聚合物涂层药物洗脱支架迟发性支架贴壁不良的发生率——一项使用光学相干断层扫描的前瞻性随机对照研究

Incidence of late-acquired stent malapposition of drug eluting stents with second generation permanent and biodegradable polymer coatings-A prospective, randomized comparison using optical coherence tomography.

作者信息

Roth Christian, Gangl Clemens, Dalos Daniel, Delle-Karth Georg, Neunteufl Thomas, Berger Rudolf

机构信息

Department of Internal Medicine II, Cardiology, Medical University of Vienna, Vienna, Austria.

Department of Internal Medicine IV, Cardiology, Hospital of Hietzing, Vienna, Austria.

出版信息

J Interv Cardiol. 2018 Dec;31(6):780-791. doi: 10.1111/joic.12572. Epub 2018 Nov 27.

DOI:10.1111/joic.12572
PMID:30479028
Abstract

OBJECTIVES AND BACKGROUND

Polymer coatings of drug-eluting stents (DES) may induce allergic reactions and inflammation, resulting in late-acquired stent malapposition (LASM) with the risk of stent thrombosis. This study evaluated, if biodegradable polymer (BP) reduces the incidence of LASM compared to permanent polymer (PP) after treatment with newer generation DES.

METHODS AND RESULTS

Fifty patients with 59 lesions were randomized (2:1) to elective treatment with second generation PP-DES (n = 32, 39 stents), either Everolimus-eluting or Zotarolimus-eluting stents, or with BP-DES (Biolimus-eluting stents [BES]; n = 18, 20 stents) and underwent optical coherence tomography directly after implantation and after 1 year. After implantation acute stent malappositions (ASM) were documented in 30 stents (51%) distributed to 22 stents treated with PP-DES (56%) and 8 with BP-DES (40%; n.s.). After 1 year, late stent malappositions (LSM) were detected in 14 stents (24 %); ASM persisted (APSM) in 9 stents after one year (7 PP-DES-18%, 2 BES-10%), whereas ASM resolved in 21 stents. In addition, LASM was documented in nine stents including five stents without and four stents with additional APSM. All LASM were located in PP-DES (n = 9; 23%), none in BP-DES (P = 0.022). Compared to the reference lumen area, in-stent lumen area of stents without LASM was smaller due to neointimal hyperplasia (P = 0.021), whereas in-stent lumen area at maximum LASM of stents with LASM was larger due to positive remodeling (P = 0.002).

CONCLUSIONS

In conclusion the use of BP-DES reduced the occurrence of LASM due to positive remodeling compared to second generation PP-DES.

摘要

目的与背景

药物洗脱支架(DES)的聚合物涂层可能引发过敏反应和炎症,导致晚期获得性支架贴壁不良(LASM),并伴有支架血栓形成的风险。本研究评估了与使用新一代DES治疗后使用永久性聚合物(PP)相比,可生物降解聚合物(BP)是否能降低LASM的发生率。

方法与结果

50例患有59处病变的患者被随机分组(2:1),接受第二代PP-DES(n = 32,39枚支架)的择期治疗,第二代PP-DES为依维莫司洗脱支架或佐他莫司洗脱支架,或接受BP-DES(生物素洗脱支架[BES];n = 18,20枚支架)治疗,并在植入后及1年后接受光学相干断层扫描。植入后,在30枚支架(51%)中记录到急性支架贴壁不良(ASM),其中22枚接受PP-DES治疗的支架(56%)和8枚接受BP-DES治疗的支架(40%)出现ASM(无统计学差异)。1年后,在14枚支架(24%)中检测到晚期支架贴壁不良(LSM);1年后,9枚支架(7枚PP-DES - 18%,2枚BES - 10%)中的ASM持续存在(APSM),而21枚支架中的ASM消失。此外,在9枚支架中记录到LASM,其中5枚无额外APSM,4枚有额外APSM。所有LASM均位于PP-DES组(n = 9;23%),BP-DES组无LASM(P = 0.022)。与参考管腔面积相比,无LASM的支架的支架内管腔面积因新生内膜增生而较小(P = 0.021),而有LASM的支架在最大LASM时的支架内管腔面积因正向重塑而较大(P = 0.002)。

结论

总之,与第二代PP-DES相比,使用BP-DES由于正向重塑减少了LASM的发生。

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