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随机 BIO-RESORT 试验中三种高度不同的当代冠状动脉药物洗脱支架治疗所有患者的两年临床结果。

Two-year clinical outcome of all-comers treated with three highly dissimilar contemporary coronary drug-eluting stents in the randomised BIO-RESORT trial.

机构信息

Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.

出版信息

EuroIntervention. 2018 Oct 20;14(8):915-923. doi: 10.4244/EIJ-D-18-00336.

Abstract

AIMS

The aim of the study was to evaluate the two-year clinical outcome of all-comer trial participants who were treated with two very different thin-strut biodegradable polymer versus thin-strut durable polymer drug-eluting stents (DES). Prolonged clinical outcome after discontinuation of dual antiplatelet therapy is of particular interest, given the highly dissimilar polymer types, amount, distribution, and degradation speed of both biodegradable polymer DES.

METHODS AND RESULTS

The BIO-RESORT trial (NCT01674803) randomly assigned 3,514 patients to treatment with biodegradable polymer SYNERGY everolimus-eluting stents (EES) or Orsiro sirolimus-eluting stents (SES), or durable polymer Resolute Integrity zotarolimus-eluting stents (ZES). At two-year follow-up (available in 98.8%), the rate of the primary composite endpoint target vessel failure (TVF) was 8.3% in ZES versus 6.8% in EES (p=0.19) and 6.6% in SES (p=0.12). Landmark analyses at one year revealed differences between SES and ZES in the rates of target lesion revascularisation and target lesion failure (0.6% vs. 1.5%, p=0.04, and 1.1% vs. 2.4%, p=0.02, respectively) as well as other composite secondary endpoints that reached statistical significance.

CONCLUSIONS

At two-year follow-up, there was no significant between-DES difference in the rates of the primary endpoint. Landmark analyses provided a signal that the use of SES versus ZES might reduce the risk of repeat revascularisation after one-year follow-up.

摘要

目的

本研究旨在评估接受两种不同的薄壁生物可降解聚合物与薄壁持久聚合物药物洗脱支架(DES)治疗的所有患者的两年临床结果。鉴于两种生物可降解聚合物 DES 的聚合物类型、数量、分布和降解速度非常不同,停止双联抗血小板治疗后的长期临床结果尤其值得关注。

方法和结果

BIO-RESORT 试验(NCT01674803)将 3514 名患者随机分为生物可降解聚合物 SYNERGY 依维莫司洗脱支架(EES)或 Orsiro 西罗莫司洗脱支架(SES)或持久聚合物 Resolute Integrity 佐他莫司洗脱支架(ZES)治疗组。在两年随访(可获得 98.8%的数据)时,ZES 组的主要复合终点靶血管失败(TVF)率为 8.3%,EES 组为 6.8%(p=0.19),SES 组为 6.6%(p=0.12)。一年时的里程碑分析显示 SES 组与 ZES 组之间在靶病变血运重建和靶病变失败的发生率上存在差异(0.6%比 1.5%,p=0.04 和 1.1%比 2.4%,p=0.02),其他复合次要终点也达到了统计学意义。

结论

在两年随访时,DES 之间主要终点的发生率没有显著差异。里程碑分析提供了一个信号,即与 ZES 相比,SES 的使用可能会降低一年后再次血运重建的风险。

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