Sanatorio Otamendi, Cardiac Unit, Capital federal, Buenos Aires, Argentina.
Catheter Cardiovasc Interv. 2011 Feb 15;77(3):335-42. doi: 10.1002/ccd.22769. Epub 2010 Nov 30.
The aim of this study was the comparison of a new double-coated paclitaxel-eluting coronary stent with bare-metal stent (BMS) in patients undergoing percutaneous coronary intervention.
Stent coating with biodegradable polymers as a platform for elution of drugs has the potential for complete elution of drugs and for decreasing the risk of late complications.
Multicenter randomized trial comparing a paclitaxel-eluting stent (PES) coated with a biodegradable polymer and glycocalyx with the equivalent BMS. We randomly assigned 422 patients with de novo coronary lesions to PES (211 patients) or to BMS (211 patients). Primary end point was target vessel failure (TVF) defined as cardiac death, myocardial infarction, and target vessel revascularization. Clinical secondary end points were target vessel revascularization, target lesion revascularization, stent thrombosis (ST), and major adverse cardiovascular events (MACE). Angiographic secondary end points were late loss and binary restenosis.
At 1 year of follow-up, TVF rate was 9.5% in the PES group and 17.1% in the BMS group (P=0.02), and MACE rate was 10% in PES and 19% in BMS arm (P=0.009). All other secondary end points were reached but ST. ST rate was low and similar in both study arms.
The study shows that patients treated with PES with dual coating technology had significantly lower incidence of TVF and MACE than those treated with BMS design; however, longer follow-up should be necessary to assess true advantages of this technology compared with the previous one.
本研究旨在比较新型双层涂层紫杉醇洗脱冠状动脉支架与裸金属支架（BMS）在经皮冠状动脉介入治疗患者中的疗效。
以可生物降解聚合物为药物洗脱平台的支架具有完全洗脱药物和降低晚期并发症风险的潜力。
多中心随机试验比较了一种涂有生物可降解聚合物和糖萼的紫杉醇洗脱支架（PES）与等效的 BMS。我们将 422 例初发冠状动脉病变患者随机分为 PES 组（211 例）或 BMS 组（211 例）。主要终点是靶血管失败（TVF），定义为心脏死亡、心肌梗死和靶血管血运重建。临床次要终点是靶血管血运重建、靶病变血运重建、支架血栓形成（ST）和主要不良心血管事件（MACE）。血管造影次要终点是晚期丢失和双相再狭窄。
在 1 年的随访中，PES 组的 TVF 发生率为 9.5%，BMS 组为 17.1%（P=0.02），PES 组的 MACE 发生率为 10%，BMS 组为 19%（P=0.009）。所有其他次要终点均达到，但 ST 除外。ST 发生率较低且在两组间相似。
该研究表明，接受双层涂层技术 PES 治疗的患者与接受 BMS 设计治疗的患者相比，TVF 和 MACE 的发生率显著降低；然而，需要更长时间的随访来评估与前一代技术相比，这种技术的真正优势。
