University of Michigan Medical Center, Ann Arbor, Michigan, USA.
PLoS One. 2010 Jun 10;5(6):e11040. doi: 10.1371/journal.pone.0011040.
Saphenous vein grafts develop an aggressive atherosclerotic process and the efficacy of drug eluting stents (DES) in treating saphenous vein graft (SVG) lesions has not been convincingly demonstrated. The aim of this study was to review and analyze the current literature for controlled studies comparing DES versus bare metal stents (BMS) for treatment of SVG stenoses.
METHODOLOGY/PRINCIPAL FINDINGS: We searched several scientific databases and conference proceedings up to March 15, 2010 for controlled studies comparing target vessel revascularization (TVR) between DES and BMS. Summary odds ratios (OR) for the primary endpoint TVR and secondary endpoints infarction, stent thrombosis and death were calculated using random-effect models. A total of 29 studies (3 randomized controlled trials RCT) involving 7549 (202 in RCT) patients were included. The need for target vessel revascularization in the DES group tended to be lower compared to BMS for the 3 RCT (OR 0.50 [0.24-1.00]; p = 0.051) and for observational studies (0.62 [0.49-0.79]; p<0.001). There was no significant difference in the risk for myocardial infarction in the RCT (OR 1.25 [0.22-6.99]; p = 0.250) but a lower risk for DES based on the observational studies 0.68 [0.49-0.95]; p = 0.023. The risk for stent thrombosis was found to be non-different in the RCT (OR 0.78 [0.03-21.73], p = 0.885) while it was in favor of DES in the observational studies (0.58 [0.38 - 0.84]; p<0.001). The mortality was not significantly different between DES and BMS in the RCT's (OR 2.22 [0.17 - 29.50]; p = 0.546) while the observation studies showed a decreased mortality in the DES group (0.69 [0.55-0.85]; p<0.001).
DES may decrease TVR rate in treatment of SVG stenoses. No differences in reinfarction rate, stent thrombosis or mortality was found between the DES and BMS groups in the RCT's while the observational data showed lower risk for myocardial infarction, stent thrombosis and death in the DES group. This may be a result of patient selection bias in the observational studies or represent a true finding that was not the detected in the RCT analysis due to limited statistical power.
大隐静脉移植物会发生侵袭性动脉粥样硬化过程，药物洗脱支架（DES）治疗大隐静脉移植物（SVG）病变的疗效尚未得到令人信服的证实。本研究旨在回顾和分析目前比较 DES 与裸金属支架（BMS）治疗 SVG 狭窄的对照研究文献。
方法/主要发现：我们检索了截至 2010 年 3 月 15 日的多个科学数据库和会议记录，以寻找比较 DES 与 BMS 治疗 SVG 狭窄的靶血管血运重建（TVR）的对照研究。使用随机效应模型计算主要终点 TVR 和次要终点心肌梗死、支架血栓形成和死亡的汇总优势比（OR）。共纳入 29 项研究（3 项随机对照试验 RCT），涉及 7549 例（202 例在 RCT 中）患者。与 BMS 相比，DES 组的靶血管血运重建需求在 3 项 RCT 中呈下降趋势（OR 0.50 [0.24-1.00]；p = 0.051）和观察性研究（0.62 [0.49-0.79]；p<0.001）。在 RCT 中，心肌梗死的风险无显著差异（OR 1.25 [0.22-6.99]；p = 0.250），但基于观察性研究，DES 风险较低（0.68 [0.49-0.95]；p = 0.023）。在 RCT 中，支架血栓形成的风险无差异（OR 0.78 [0.03-21.73]，p = 0.885），而在观察性研究中，DES 更有利（0.58 [0.38-0.84]；p<0.001）。在 RCT 中，DES 与 BMS 之间的死亡率无显著差异（OR 2.22 [0.17-29.50]；p = 0.546），而观察性研究显示 DES 组死亡率降低（0.69 [0.55-0.85]；p<0.001）。
DES 可能降低 SVG 狭窄治疗的 TVR 发生率。在 RCT 中，DES 与 BMS 之间再梗死率、支架血栓形成率或死亡率无差异，而观察性数据显示 DES 组心肌梗死、支架血栓形成和死亡率较低。这可能是由于观察性研究中的患者选择偏倚，也可能代表由于统计效力有限而在 RCT 分析中未检测到的真实发现。
