Dipartimento Cardiovascolare, Policlinico Sant' Orsola, Bologna, Italy.
Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy.
J Am Coll Cardiol. 2014 Feb 4;63(4):299-307. doi: 10.1016/j.jacc.2013.09.061. Epub 2013 Nov 6.
This study sought to investigate the relative safety and efficacy of bioabsorbable polymer (BP)-based biolimus-eluting stents (BES) versus durable-polymer (DP)-drug-eluting stents (DES) and bare-metal stents (BMS) by means of a network meta-analysis.
Studies have suggested that BP-BES might reduce the risk of stent thrombosis (ST) and late adverse outcomes compared with first-generation DES. However, the relative safety and efficacy of BP-BES versus newer-generation DES coated with more biocompatible DP have not been investigated in depth.
Randomized controlled trials comparing BP-BES versus currently U.S.-approved DES or BMS were searched through MEDLINE, EMBASE, and Cochrane databases. Information on study design, inclusion and exclusion criteria, sample characteristics, and clinical outcomes was extracted.
Data from 89 trials including 85,490 patients were analyzed. At 1-year follow-up, BP-BES were associated with lower rates of cardiac death/myocardial infarction (MI), MI, and target vessel revascularization (TVR) than BMS and lower rates of TVR than fast-release zotarolimus-eluting stents. The BP-BES had similar rates of cardiac death/MI, MI, and TVR compared with other second-generation DP-DES but higher rates of 1-year ST than cobalt-chromium everolimus-eluting stents (CoCr-EES). The BP-BES were associated with improved late outcomes compared with BMS and paclitaxel-eluting stents, considering the latest follow-up data available, with nonsignificantly different outcomes compared with other DP-DES although higher rates of definite ST compared with CoCr-EES.
In this large-scale network meta-analysis, BP-BES were associated with superior clinical outcomes compared with BMS and first-generation DES and similar rates of cardiac death/MI, MI, and TVR compared with second-generation DP-DES but higher rates of definite ST than CoCr-EES.
本研究通过网状meta 分析旨在探讨生物可吸收聚合物（BP）载药支架（BES）与持久性聚合物（DP）药物洗脱支架（DES）和裸金属支架（BMS）相比的相对安全性和疗效。
研究表明，BP-BES 可能降低支架血栓形成（ST）和晚期不良结局的风险，与第一代 DES 相比。然而，BP-BES 与采用更生物相容性 DP 涂层的新一代 DES 相比的相对安全性和疗效尚未深入研究。
通过 MEDLINE、EMBASE 和 Cochrane 数据库检索比较 BP-BES 与目前美国批准的 DES 或 BMS 的随机对照试验。提取研究设计、纳入和排除标准、样本特征和临床结局信息。
纳入 89 项试验共 85490 例患者的数据进行分析。在 1 年随访时，BP-BES 与 BMS 相比，心脏死亡/心肌梗死（MI）、MI 和靶血管血运重建（TVR）的发生率较低，与快速洗脱佐他莫司洗脱支架相比，TVR 的发生率较低。BP-BES 与其他第二代 DP-DES 的心脏死亡/MI、MI 和 TVR 发生率相似，但 1 年 ST 的发生率高于钴铬依维莫司洗脱支架（CoCr-EES）。BP-BES 与 BMS 和紫杉醇洗脱支架相比，具有改善的晚期结局，考虑到最新的随访数据，与其他 DP-DES 相比，结果无显著差异，尽管与 CoCr-EES 相比，确定 ST 的发生率较高。
在这项大规模的网状 meta 分析中，BP-BES 与 BMS 和第一代 DES 相比具有更好的临床结局，与第二代 DP-DES 相比，心脏死亡/MI、MI 和 TVR 的发生率相似，但与 CoCr-EES 相比，确定 ST 的发生率较高。
