Suzuki Teruhiko, Ishikawa Tetsuya, Nakano Yosuke, Hino Shouryoku, Mutoh Makoto
Division of Cardiology, Saitama Cardiovascular Respiratory Center, Japan.
Intern Med. 2014;53(12):1265-73. doi: 10.2169/internalmedicine.53.2027. Epub 2014 Jun 15.
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.
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.
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.
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.
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。
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。
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。
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。