使用Absorb生物可吸收血管支架治疗的糖尿病患者的临床结局：欧洲多中心GHOST-EU注册研究的亚组分析

Clinical outcomes of patients with diabetes mellitus treated with Absorb bioresorbable vascular scaffolds: a subanalysis of the European Multicentre GHOST-EU Registry.

作者信息

Capranzano Piera, Capodanno Davide, Brugaletta Salvatore, Latib Azeem, Mehilli Julinda, Nef Holger, Gori Tommaso, Lesiak Maciej, Geraci Salvatore, Pyxaras Stelios, Mattesini Alessio, Münzel Thomas, Araszkiewicz Aleksander, Caramanno Giuseppe, Naber Christoph, Di Mario Carlo, Sabatè Manel, Colombo Antonio, Wiebe Jens, Tamburino Corrado

机构信息

Cardiovascular department, Ferrarotto Hospital, University of Catania, Catania, Italy.

Department of Cardiology, Clinic Cardiovascular Institute, Hospital Clinic, Biomedical Investigation Institute, IDIBAPS, University of Barcelona, Spain.

出版信息

Catheter Cardiovasc Interv. 2018 Feb 15;91(3):444-453. doi: 10.1002/ccd.27388. Epub 2017 Oct 25.

DOI:10.1002/ccd.27388

PMID:29068130

Abstract

BACKGROUND

Data on the clinical performance of bioresorbable scaffolds in patients with diabetes mellitus (DM) are still limited. The present study reported 1-year clinical outcomes associated with the use of everolimus-eluting bioresorbable vascular scaffolds (Absorb BVS; Abbott Vascular, Santa Clara, CA) in DM patients.

METHODS AND RESULTS

This was a subanalysis from the GHOST-EU (Gauging coronary Healing with biOresorbable Scaffolding plaTforms in Europe) multicenter retrospective registry including patients treated with Absorb BVS between November 2011 and September 2014. In this study, a comparative analysis stratified according to DM was performed. The primary endpoint was target lesion failure (TLF), defined as the combination of cardiac death, target-vessel myocardial infarction (MI) and clinically-driven target-lesion revascularization (TLR). A total of 1,477 patients were treated with 2,224 Absorb BVS; 381 (25.8%) and 1,096 (74.2%) patients were with and without DM, respectively. The 1-year rate of TLF was higher among patients with DM (7.8%) than those without DM (4.3%); the increase in TLF was driven by TLR (6.5% vs. 3.3%, P = 0.009); no significant differences in cardiac death (1.1% vs. 0.9%, P = 0.68) and target-vessel MI (3.1% vs. 2.2%, P = 0.38) were observed, respectively. Definite/probable scaffold thrombosis rate tended to be higher among patients with DM than those without DM (3.0% vs. 1.7%, P = 0.14, respectively).

CONCLUSIONS

Absorb BVS use in patients with DM was associated with increased 1-year TLF and scaffold thrombosis compared with non-diabetes patients.

摘要

背景

关于生物可吸收支架在糖尿病（DM）患者中的临床性能数据仍然有限。本研究报告了在DM患者中使用依维莫司洗脱生物可吸收血管支架（Absorb BVS；雅培血管，加利福尼亚州圣克拉拉）的1年临床结局。

方法与结果

这是一项来自GHOST-EU（欧洲生物可吸收支架平台评估冠状动脉愈合情况）多中心回顾性注册研究的亚分析，纳入了2011年11月至2014年9月期间接受Absorb BVS治疗的患者。在本研究中，进行了根据DM分层的比较分析。主要终点是靶病变失败（TLF），定义为心源性死亡、靶血管心肌梗死（MI）和临床驱动的靶病变血运重建（TLR）的组合。共有1477例患者接受了2224个Absorb BVS治疗；分别有381例（25.8%）和1096例（74.2%）患者患有和未患有DM。DM患者的1年TLF发生率高于非DM患者（7.8%对4.3%）；TLF的增加是由TLR驱动的（6.5%对3.3%，P = 0.009）；在心源性死亡（1.1%对0.9%，P = 0.68）和靶血管MI（3.1%对2.2%，P = 0.38）方面未观察到显著差异。DM患者的明确/可能支架血栓形成率倾向于高于非DM患者（分别为3.0%对1.7%，P = 0.14）。