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使用保险理赔数据库进行的全国性回顾性队列研究:不同雷帕霉素类药物洗脱支架治疗低风险冠状动脉疾病患者的临床结局

Clinical outcomes in low risk coronary artery disease patients treated with different limus-based drug-eluting stents--a nationwide retrospective cohort study using insurance claims database.

作者信息

Lai Chao-Lun, Wu Ching-Fen, Kuo Raymond Nien-Chen, Yang Yen-Yun, Chen Ming-Fong, Chan K Arnold, Lai Mei-Shu

机构信息

Department of Internal Medicine and Center for Critical Care Medicine, National Taiwan University Hospital Hsin-Chu Branch, Hsin-Chu, Taiwan; Department of Internal Medicine, College of Medicine, National Taiwan University, Taipei, Taiwan; Institute of Epidemiology and Preventive Medicine, College of Public Health, National Taiwan University, Taipei, Taiwan.

Department of Internal Medicine, Mennonite Christian Hospital, Hualien, Taiwan.

出版信息

PLoS One. 2015 Apr 7;10(4):e0122860. doi: 10.1371/journal.pone.0122860. eCollection 2015.

Abstract

The clinical outcomes of different limus-based drug-eluting stents (DES) in a real-world setting have not been well defined. The aim of this study was to investigate the clinical outcomes of three different limus-based DES, namely sirolimus-eluting stent (SES), Endeavor zotarolimus-eluting stent (E-ZES) and everolimus-eluting stent (EES), using a national insurance claims database. We identified all patients who received implantation of single SES, E-ZES or EES between January 1, 2007 and December 31, 2009 from the National Health Insurance claims database, Taiwan. Follow-up was through December 31, 2011 for all selected clinical outcomes. The primary end-point was all-cause mortality. Secondary end-points included acute coronary events, heart failure needing hospitalization, and cerebrovascular disease. Cox regression model adjusting for baseline characteristics was used to compare the relative risks of different outcomes among the three different limus-based DES. Totally, 6584 patients were evaluated (n=2142 for SES, n=3445 for E-ZES, and n=997 for EES). After adjusting for baseline characteristics, we found no statistically significant difference in the risk of all-cause mortality in three DES groups (adjusted hazard ratio [HR]: 1.14, 95% confidence interval [CI]: 0.94-1.38, p=0.20 in E-ZES group compared with SES group; adjusted HR: 0.77, 95% CI: 0.54-1.10, p=0.15 in EES group compared with SES group). Similarly, we found no difference in the three stent groups in risks of acute coronary events, heart failure needing hospitalization, and cerebrovascular disease. In conclusion, we observed no difference in all-cause mortality, acute coronary events, heart failure needing hospitalization, and cerebrovascular disease in patients treated with SES, E-ZES, and EES in a real-world population-based setting in Taiwan.

摘要

在真实临床环境中,不同雷帕霉素洗脱支架(DES)的临床疗效尚未明确界定。本研究旨在利用全国保险理赔数据库,探究三种不同的雷帕霉素洗脱支架,即西罗莫司洗脱支架(SES)、安进佐他莫司洗脱支架(E-ZES)和依维莫司洗脱支架(EES)的临床疗效。我们从台湾全民健康保险理赔数据库中,识别出2007年1月1日至2009年12月31日期间接受单支SES、E-ZES或EES植入的所有患者。对所有选定的临床结局随访至2011年12月31日。主要终点为全因死亡率。次要终点包括急性冠脉事件、需住院治疗的心力衰竭和脑血管疾病。采用调整基线特征的Cox回归模型,比较三种不同雷帕霉素洗脱支架不同结局的相对风险。总共评估了6584例患者(SES组2142例,E-ZES组3445例,EES组997例)。在调整基线特征后,我们发现三个DES组在全因死亡率风险方面无统计学显著差异(与SES组相比,E-ZES组调整后风险比[HR]:1.14,95%置信区间[CI]:0.94 - 1.38,p = 0.20;与SES组相比,EES组调整后HR:0.77,95% CI:0.54 - 1.10,p = 0.15)。同样,我们发现三个支架组在急性冠脉事件、需住院治疗的心力衰竭和脑血管疾病风险方面无差异。总之,在台湾基于人群的真实临床环境中,接受SES、E-ZES和EES治疗的患者在全因死亡率、急性冠脉事件、需住院治疗的心力衰竭和脑血管疾病方面未观察到差异。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6e7b/4388589/cb681dc39586/pone.0122860.g001.jpg

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