Department of Cardiology, Cardiovascular Institute and Fu Wai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100037, China.
Chin Med J (Engl). 2010 Apr 5;123(7):810-5.
Recent studies have shown that drug eluting stent (DES) implantation improved clinical outcome concerning efficacy compared with bare-metal stent (BMS) implantation, and sirolimus-eluting stent (SES) seemed superior to paclitaxel-eluting stent (PES) in improving the outcomes. Firebird SES is the most widely used SES in China. Long-term comparison of safety and efficacy between Firebird SES and Taxus PES in Chinese population is still not available. The aim of this research was to compare the safety and efficacy at 24 months after the successful implantation of Firebird SES and TAXUS PES in Chinese population.
From April 2004 to October 2006, 3110 consecutive patients who underwent successful DES (Firebird SES 2274; Taxus PES 836) implantation were prospectively enrolled into this study. All enrolled patients were divided into two groups based on stent type. By outpatient clinic visit and telephone interview, we obtained 24-month clinical outcome including death, myocardial infarction (MI), thrombosis, target lesion revascularization (TLR), target vessel revascularization (TVR), and major adverse cardiac events (MACE, the composite of death, MI, and TVR). We used Cox's proportional-hazards models to assess relative risks of all the outcome measures before and after propensity match.
Unadjusted clinical outcomes indicated that the patients treated with Firebird SES were associated with lower risk of TLR (HR 0.38, 95%CI 0.26 - 0.54), TVR (HR 0.51, 95%CI 0.38 - 0.68) and MACE (HR 0.53, 95%CI 0.41 - 0.68). The results after propensity match were consistent with that before matching, lower risk of TLR (HR 0.33, 95%CI 0.19 - 0.58), TVR (HR 0.41, 95%CI 0.26 - 0.64), MACE (HR 0.48, 95%CI 0.33 - 0.68) in Firebird group.
Compared with Taxus PES, the use of domestic Firebird SES may decrease the risk of TLR, TVR and MACE in daily practice.
最近的研究表明，与金属裸支架（BMS）植入相比，药物洗脱支架（DES）植入在疗效方面改善了临床结局，而西罗莫司洗脱支架（SES）似乎优于紫杉醇洗脱支架（PES）改善结果。火鸟 SES 是中国应用最广泛的 SES。在中国人群中，火鸟 SES 和 Taxus PES 的长期安全性和疗效比较尚不清楚。本研究旨在比较中国人群中火鸟 SES 和 Taxus PES 成功植入后 24 个月的安全性和疗效。
2004 年 4 月至 2006 年 10 月，前瞻性纳入 3110 例成功植入 DES（火鸟 SES 2274 例；Taxus PES 836 例）的连续患者。所有入选患者均根据支架类型分为两组。通过门诊就诊和电话访谈，我们获得了 24 个月的临床结局，包括死亡、心肌梗死（MI）、血栓形成、靶病变血运重建（TLR）、靶血管血运重建（TVR）和主要不良心脏事件（MACE，死亡、MI 和 TVR 的复合终点）。我们使用 Cox 比例风险模型评估倾向性匹配前后所有结局指标的相对风险。
未经调整的临床结局表明，接受火鸟 SES 治疗的患者 TLR（风险比[HR]0.38，95%可信区间[CI]0.26-0.54）、TVR（HR 0.51，95%CI 0.38-0.68）和 MACE（HR 0.53，95%CI 0.41-0.68）的风险较低。倾向性匹配后的结果与匹配前一致，火鸟组 TLR（HR 0.33，95%CI 0.19-0.58）、TVR（HR 0.41，95%CI 0.26-0.64）、MACE（HR 0.48，95%CI 0.33-0.68）的风险较低。
与 Taxus PES 相比，国产火鸟 SES 的使用可能会降低日常实践中 TLR、TVR 和 MACE 的风险。
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