Danzi Gian Battista, Piccolo Raffaele, Galasso Gennaro, Piscione Federico
Division of Cardiology, Ospedale "Santa Corona"
Circ J. 2014;78(8):1858-66. doi: 10.1253/circj.cj-13-1558. Epub 2014 Jun 3.
Permanent polymer coatings on drug-eluting stents (DES) surface have been identified as triggers of adverse events following percutaneous coronary intervention (PCI). However, efficacy and safety data for the Nobori biolimus-eluting stent (BES), a biodegradable polymer DES, are limited, so the aim of this study was to evaluate clinical outcomes associated with the Nobori BES compared with permanent polymer DES in patients undergoing PCI.
Randomized trials comparing Nobori BES vs. other DES were included in the meta-analysis. The 12-month clinical endpoints were: target lesion revascularization (TLR), all-cause mortality, myocardial infarction (MI) and stent thrombosis (ST). Seven trials totaling 12,090 PCI patients met the inclusion criteria. Nobori BES vs. other DES had a comparable risk of TLR (odds ratio [OR] 0.94; 95% confidence interval [CI], 0.66-1.34; P=0.74), mortality (OR 1.00; 95% CI, 0.78-1.28; P=0.98), MI (OR 1.10; 95% CI, 0.87-1.40; P=0.42) and definite/probable ST (OR 1.01; 95% CI, 0.45-2.25; P=0.99). Despite Nobori BES showing similar clinical results to sirolimus-, everolimus- and zotarolimus-eluting stents, it was superior to paclitaxel-eluting stents in reducing the risk of TLR (OR 0.31; 95% CI, 0.10-0.90; P=0.03)CONCLUSIONS:Nobori BES use is associated with a similar safety and efficacy as permanent polymer DES at 1-year follow-up, albeit it is superior to paclitaxel-eluting stents in terms of TLR. Long-term follow-up data are needed in order to establish whether polymer degradation related to Nobori BES implantation improves clinical outcomes.
药物洗脱支架（DES）表面的永久性聚合物涂层已被确认为经皮冠状动脉介入治疗（PCI）后不良事件的触发因素。然而，可生物降解聚合物DES——Nobori生物雷帕霉素洗脱支架（BES）的疗效和安全性数据有限，因此本研究的目的是评估与Nobori BES相比，接受PCI的患者使用永久性聚合物DES的临床结局。
比较Nobori BES与其他DES的随机试验被纳入荟萃分析。12个月的临床终点为：靶病变血运重建（TLR）、全因死亡率、心肌梗死（MI）和支架血栓形成（ST）。共有7项试验、总计12090例接受PCI的患者符合纳入标准。Nobori BES与其他DES相比，TLR风险相当（优势比[OR]0.94；95%置信区间[CI]，0.66 - 1.34；P = 0.74），死亡率（OR 1.00；95% CI，0.78 - 1.28；P = 0.98），MI（OR 1.10；95% CI，0.87 - 1.40；P = 0.42）以及明确/可能的ST（OR 1.01；95% CI，0.45 - 2.25；P = 0.99）。尽管Nobori BES显示出与西罗莫司、依维莫司和佐他莫司洗脱支架相似的临床结果，但在降低TLR风险方面优于紫杉醇洗脱支架（OR 0.31；95% CI，0.10 - 0.90；P = ０.03）。
在1年随访中，使用Nobori BES与永久性聚合物DES具有相似的安全性和疗效，尽管在TLR方面优于紫杉醇洗脱支架。需要长期随访数据以确定与Nobori BES植入相关的聚合物降解是否能改善临床结局。
