Edifoligide and long-term outcomes after coronary artery bypass grafting: PRoject of Ex-vivo Vein graft ENgineering via Transfection IV (PREVENT IV) 5-year results
Edifoligide and long-term outcomes after coronary artery bypass grafting: PRoject of Ex-vivo Vein graft ENgineering via Transfection IV (PREVENT IV) 5-year results
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DOI：
10.1016/j.ahj.2012.05.019
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发表时间：
2012-09-01
影响因子：
4.8
通讯作者：
Alexander, John H.
中科院分区：
文献类型：
--
作者：
Lopes, Renato D.;Williams, Judson B.;Alexander, John H.
Edifoligide是一种E2F转录因子诱骗剂，它不能预防冠状动脉旁路移植术（CABG）患者1年内的静脉移植衰竭或不良临床结果。我们比较了用二叶酸内酯和安慰剂治疗的预防IV组患者的5年临床结果，以确定长期临床结果的预测因子。方法对3014例行冠脉搭桥且至少2例计划静脉移植的患者进行研究。生成Kaplan-Meier曲线来比较二叶酸内酯和安慰剂的长期效果。构建Cox比例风险模型以确定与cabg术后5年预后相关的因素。主要结局指标为5年内死亡、心肌梗死（MI）、重复血运重建术和再住院。结果完成5年随访2865例（95.1%）。5年时，随机分配到二叶酸酯组和安慰剂组的患者死亡率（分别为11.7%和10.7%）、心肌梗死（2.3%和3.2%）、血运重建术（14.1%和13.9%）和再住院（61.6%和62.5%）相似。死亡、心肌梗死或血运重建的复合结局在二叶酸酯组和安慰剂组中发生的频率相似（分别为26.3%和25.5%；风险比为1.03 [95% CI 0.89-1.18], P = .721）。5年时与死亡、心肌梗死或血运重建相关的因素包括外周和/或脑血管疾病、体外循环时间、肺病、糖尿病和充血性心力衰竭。结论：多达四分之一的CABG患者在手术5年内会发生重大心脏事件或重复血运重建术。Edifoligide不影响CABG后的预后；然而，常见的可识别基线和程序性危险因素与冠脉搭桥术后的长期预后相关。[J] .中国医学杂志；2012;33 (4):379- 376 .]
Background Edifoligide, an E2F transcription factor decoy, does not prevent vein graft failure or adverse clinical outcomes at 1 year in patients undergoing coronary artery bypass grafting (CABG). We compared the 5-year clinical outcomes of patients in PREVENT IV treated with edifoligide and placebo to identify predictors of long-term clinical outcomes.Methods A total of 3,014 patients undergoing CABG with at least 2 planned vein grafts were enrolled. Kaplan-Meier curves were generated to compare the long-term effects of edifoligide and placebo. A Cox proportional hazards model was constructed to identify factors associated with 5-year post-CABG outcomes. The main outcome measures were death, myocardial infarction (MI), repeat revascularization, and rehospitalization through 5 years.Results Five-year follow-up was complete in 2,865 patients (95.1%). At 5 years, patients randomized to edifoligide and placebo had similar rates of death (11.7% and 10.7%, respectively), MI (2.3% and 3.2%), revascularization (14.1% and 13.9%), and rehospitalization (61.6% and 62.5%). The composite outcome of death, MI, or revascularization occurred at similar frequency in patients assigned to edifoligide and placebo (26.3% and 25.5%, respectively; hazard ratio 1.03 [95% CI 0.89-1.18], P = .721). Factors associated with death, MI, or revascularization at 5 years included peripheral and/or cerebrovascular disease, time on cardiopulmonary bypass, lung disease, diabetes mellitus, and congestive heart failure.Conclusions Up to a quarter of patients undergoing CABG will have a major cardiac event or repeat revascularization procedure within 5 years of surgery. Edifoligide does not affect outcomes after CABG; however, common identifiable baseline and procedural risk factors are associated with long-term outcomes after CABG. (Am Heart J 2012;164:379-386.e1.)