Tarantini Giuseppe, Barioli Alberto, Facchin Michela, Frigo Anna C, Napodano Massimo, Buja Paolo, D'Amico Gianpiero, Iliceto Sabino, Isabella Giambattista
Department of Cardiac, Thoracic and Vascular Sciences, University of Padua Medical School, Via Giustiniani 2, Padua, Italy.
Coron Artery Dis. 2013 Aug;24(5):440-8. doi: 10.1097/MCA.0b013e328362b2ab.
Drug-eluting stents are more effective in reducing restenosis than bare-metal stents. Paclitaxel-eluting stents (PES) and sirolimus-eluting stents (SES) are the most widely used first-generation drug-eluting stents, but long-term comparative data on these are scant. The aim of the present report is to investigate the 6-year clinical outcomes of PES versus SES in a matched cohort of single-center registry patients.
Data were obtained from the observational, monocentric registry of 632 consecutive patients who underwent percutaneous coronary intervention between September 2002 and September 2005 with PES or SES. We assessed the composite and separate occurrence of the major adverse cardiac events (MACE), including death, nonfatal myocardial infarction, and target lesion revascularization (TLR).
After a propensity 1 : 1 matching analysis, baseline clinical, procedural, and angiographic characteristics were well balanced between the two groups. Throughout the 6 years of follow-up, there were no significant differences between PES and SES in terms of MACE (P=0.52), all-cause death (P=0.24), myocardial infarction (P=0.25), stent thrombosis (P=0.38), and TLR (P=0.68). The sensitivity analysis on the total unmatched population confirmed this result, the stent type not being predictive of MACE (PES vs. SES group, hazard ratio 0.97, 95% confidence interval 0.66-1.41, P=0.87) or TLR (PES vs. the SES group, hazard ratio 1.35, 95% confidence interval 0.69-2.64, P=0.38).
In this 'real-life' registry, PES and SES showed a comparable safety and efficacy profile throughout the 6 years of follow-up. The increase in the rate of TLR was slow and comparable between the two groups, even though the 'late catch-up' phenomenon showed a different temporal pattern between PES and SES.
药物洗脱支架在减少再狭窄方面比裸金属支架更有效。紫杉醇洗脱支架（PES）和西罗莫司洗脱支架（SES）是应用最广泛的第一代药物洗脱支架，但关于它们的长期对比数据很少。本报告的目的是在单中心注册患者的匹配队列中研究PES与SES的6年临床结局。
数据来自于2002年9月至2005年9月间连续632例接受经皮冠状动脉介入治疗并植入PES或SES的患者的单中心观察性注册研究。我们评估了主要不良心脏事件（MACE）的复合及单独发生情况，包括死亡、非致命性心肌梗死和靶病变血运重建（TLR）。
经过倾向评分1:1匹配分析后，两组间的基线临床、手术及血管造影特征达到良好平衡。在整个6年的随访期间，PES和SES在MACE（P = 0.52）、全因死亡（P = 0.24）、心肌梗死（P = 0.25）、支架血栓形成（P = 0.38）和TLR（P = 0.68）方面均无显著差异。对未匹配总体人群的敏感性分析证实了这一结果，支架类型并非MACE（PES组与SES组，风险比0.97，95%置信区间0.66 - 1.41，P = 0.87）或TLR（PES组与SES组，风险比1.35，95%置信区间0.69 - 2.64，P = 0.38）的预测因素。
在这个“真实世界”的注册研究中，PES和SES在6年随访期间显示出相当的安全性和有效性。TLR发生率的上升较为缓慢，两组间相当，尽管“晚期追赶”现象在PES和SES之间呈现出不同的时间模式。
