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TAXUS Liberté支架与Cypher Bx Velocity支架治疗初发原位冠状动脉狭窄及糖尿病患者中期血管造影结果的基于倾向评分匹配病变的比较

Propensity score-matched lesion-based comparison of mid-term angiographic outcomes of TAXUS Liberté with Cypher Bx Velocity stents for de novo native coronary stenosis and in patients with diabetes.

作者信息

Suzuki Teruhiko, Ishikawa Tetsuya, Nakano Yosuke, Hino Shouryoku, Mutoh Makoto

机构信息

Division of Cardiology, Saitama Cardiovascular Respiratory Center, Japan.

出版信息

Intern Med. 2014;53(12):1265-73. doi: 10.2169/internalmedicine.53.2027. Epub 2014 Jun 15.

DOI:10.2169/internalmedicine.53.2027
PMID:24930644
Abstract

OBJECTIVE

We sought to perform a propensity score-matched lesion-based comparison of mid-term angiographic outcomes of sirolimus- (SES, Cypher Bx Velocity) and paclitaxel- (PES, TAXUS Liberté, the 2nd-generation TAXUS) eluting stents to treat de novo coronary stenosis and, particularly, in patients with diabetes mellitus (DM) in a daily practice environment.

METHODS

The present study was a non-randomized, retrospective, lesion-based, single center study that included 1,287 de novo native coronary stenosis cases after successful SES or PES placement between February 2007 and April 2011. The primary endpoint was angiographic-based binary in-stent restenosis (% diameter stenosis >50 at secondary angiogram) within 550 days of placement. A propensity score-matched analysis was used to adjust the baselines.

RESULTS

Among 360 baseline-adjusted angiographic lesions followed up in each arm, the incidence of the primary endpoint in the PES group (11.7%, follow-up period: 350±76 days) was not significantly different from that in the SES group (10.3%, p=0.645, 354±81 days, p=0.912). PES was not associated with the primary endpoint by logistic regression analysis (odds ratio: 1.15, 95% confidence interval: 0.68-1.93, p=0.605). In the DM specific sub-analysis, the primary endpoint in the PES group (19.6%) was not significantly different from that in the SES group (12.8%, p=0.105) in 148 baseline-adjusted lesions in each arm.

CONCLUSION

The mid-term angiographic outcomes after TAXUS Liberté placement for all-comer de novo native coronary stenosis and in patients with DM were not significantly different from those of SES in a Japanese daily practice environment.

摘要

目的

我们试图在日常临床环境中,对雷帕霉素洗脱支架(SES,Cypher Bx Velocity)和紫杉醇洗脱支架(PES,TAXUS Liberté,第二代TAXUS)治疗初发冠状动脉狭窄,尤其是糖尿病(DM)患者的中期血管造影结果进行基于倾向评分匹配病变的比较。

方法

本研究是一项非随机、回顾性、基于病变的单中心研究,纳入了2007年2月至2011年4月期间成功植入SES或PES后1287例初发冠状动脉狭窄病例。主要终点是植入后550天内基于血管造影的支架内再狭窄二元指标(二次血管造影时直径狭窄百分比>50%)。采用倾向评分匹配分析来调整基线。

结果

每组随访360个经基线调整的血管造影病变,PES组主要终点发生率(11.7%,随访期:350±76天)与SES组(10.3%,p=0.645,354±81天,p=0.912)无显著差异。经逻辑回归分析,PES与主要终点无关(优势比:1.15,95%置信区间:0.68-1.93,p=0.605)。在糖尿病特异性亚组分析中,每组148个经基线调整的病变中,PES组主要终点(19.6%)与SES组(12.8%,p=0.105)无显著差异。

结论

在日本日常临床环境中,对于所有初发冠状动脉狭窄患者及糖尿病患者,植入TAXUS Liberté后的中期血管造影结果与SES无显著差异。

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