Yin Yangguang, Zhang Yao, Zhao Xiaohui
Cardiovascular Disease Research Center, Xinqiao Hospital, Third Military Medical University, Chongqing, China.
The Evidence Based Medicine and Clinic Epidemiology Center, Third Military Medical University, Chongqing, China.
PLoS One. 2014 Jun 19;9(6):e99648. doi: 10.1371/journal.pone.0099648. eCollection 2014.
Biodegradable polymeric coatings have been proposed as a promising strategy to enhance biocompatibility and improve the delayed healing in the vessel. However, the efficacy and safety of biodegradable polymer drug-eluting stents (BP-DES) vs. bare metal stents (BMS) are unknown. The aim of this study was to perform a meta-analysis of randomized controlled trials (RCTs) comparing the outcomes of BP-DES vs. BMS.
PubMed, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) were searched for randomized clinical trials, until December 2013, that compared any of approved BP-DES and BMS. Efficacy endpoints were target-vessel revascularization (TVR), target-lesion revascularization (TLR) and in-stent late loss (ISLL). Safety endpoints were death, myocardial infarction (MI), definite stent thrombosis (DST). The meta-analysis included 7 RCTs with 2,409 patients. As compared with BMS, there was a significantly reduced TVR (OR [95% CI] = 0.37 [0.28-0.50]), ISLL (OR [95% CI] = -0.41 [-0.48-0.34]) and TLR (OR [95% CI] = 0.38 [0.27-0.52]) in BP-DES patients. However, there were no difference for safety outcomes between BP-DES and BMS.
BP-DES is more effective in reducing ISLL, TVR and TLR, as safe as standard BMS with regard to death, ST and MI. Further large RCTs with long-term follow-up are warranted to better define the relative merits of BP-DES.
可生物降解的聚合物涂层已被提议作为一种有前景的策略，以增强生物相容性并改善血管延迟愈合。然而，可生物降解聚合物药物洗脱支架（BP-DES）与裸金属支架（BMS）相比的疗效和安全性尚不清楚。本研究的目的是对比较BP-DES与BMS结果的随机对照试验（RCT）进行荟萃分析。
检索了PubMed、Embase和Cochrane对照试验中央注册库（CENTRAL），以查找截至2013年12月比较任何已批准的BP-DES和BMS的随机临床试验。疗效终点为靶血管重建（TVR）、靶病变重建（TLR）和支架内晚期管腔丢失（ISLL）。安全终点为死亡、心肌梗死（MI）、明确的支架血栓形成（DST）。荟萃分析纳入了7项RCT，共2409例患者。与BMS相比，BP-DES患者的TVR（比值比[95%置信区间]=0.37[0.28-0.50]）、ISLL（比值比[95%置信区间]=-0.41[-0.48-0.34]）和TLR（比值比[95%置信区间]=0.38[0.27-0.52]）显著降低。然而，BP-DES和BMS之间的安全结局没有差异。
BP-DES在降低ISLL、TVR和TLR方面更有效，在死亡、支架血栓形成和MI方面与标准BMS一样安全。有必要进行进一步的长期随访大型RCT，以更好地确定BP-DES的相对优势。
