与在隐静脉移植物中使用裸金属支架相比，使用药物洗脱支架缺乏临床长期益处。

Lack of clinical long-term benefit with the use of a drug eluting stent compared to use of a bare metal stent in saphenous vein grafts.

作者信息

Gioia Giuseppe, Benassi Alberto, Mohendra Raghar, Chowdhury Khaza, Masood Iqbal, Matthai William

出版信息

Catheter Cardiovasc Interv. 2008 Jul 1;72(1):13-20. doi: 10.1002/ccd.21599.

DOI:10.1002/ccd.21599

PMID:18561143

Abstract

BACKGROUND

Small randomized trials have shown short-term improved outcome with drug-eluting stents (DES) over bare metal stent (BMS) in saphenous vein graft (SVG) interventions by reducing in-stent restenosis and target vessel revascularization (TVR). It is not clear, however, if these benefits are maintained long term. The aim of this study is to compare the outcome in a larger cohort of patients undergoing SVG stent implantation with DES or BMS, at 2 years.

METHODS

From among 250 patients who underwent SVG stenting, 225 patients with available follow-up were selected from data bases at the three participating institutions. One-hundred-six patients had DES (sirolimus, paclitaxel or tacrolimus eluting stent) and 119 patients had any available BMS from April 2002 to December 2006. The primary endpoint was MACE rate, a combination of cardiac death, S-T elevation myocardial infarction (STEMI) and target lesion revascularization. Secondary end points were the individual components of the primary endpoint. Follow-up was obtained by mailed interviews or telephone calls and review of the hospital chart.

RESULTS

The DES and BMS groups had similar age (71 +/- 8 years vs. 70 +/- 7 years, P = 1.0), diabetes (45% vs. 36%, P = 0.3), history of MI (58% vs. 51%, P = 0.6), EF (44% vs. 47%, P = 0.2) and previous PCI (40% vs. 35%, P = 0.4). Reference vessel diameter (3.15 +/- 0.5 mm vs. 3.5 +/- 0.5 mm. P = 0.001) and stent size (3.3 +/- 0.4 mm vs. 3.9 +/- 0.5 mm, P = 0.001) were smaller in the DES group; however, the BMS were longer (24 +/- 10 mm vs. 21 +/- 6 mm, P = 0.05). At one year there was a trend (P = 0.1) for lower MACE rate in the DES group, but at two years there was no difference in MACE free survival between the DES and BMS groups (81 % vs. 82%, P = 0.9). The death rate was similar (6% each) with three patients having STEMI (two in the DES and one in the BMS). TVR was also similar (14% in each group).

CONCLUSION

In patients undergoing treatment of SVG disease with a stent, the marginal benefit of DES seen at 1 year was lost at 2-year follow-up.

摘要

背景

小型随机试验表明，在隐静脉搭桥术（SVG）干预中，药物洗脱支架（DES）较裸金属支架（BMS）可通过减少支架内再狭窄和靶血管重建（TVR）在短期内改善预后。然而，这些益处能否长期维持尚不清楚。本研究的目的是比较在更大队列的接受SVG支架植入术的患者中，使用DES或BMS在2年时的预后情况。

方法

在250例行SVG支架置入术的患者中，从三个参与机构的数据库中选取225例有可用随访资料的患者。2002年4月至2006年12月期间，106例患者使用DES（西罗莫司、紫杉醇或他克莫司洗脱支架），119例患者使用任何可用的BMS。主要终点是主要不良心血管事件（MACE）发生率，包括心源性死亡、ST段抬高型心肌梗死（STEMI）和靶病变血管重建的综合情况。次要终点是主要终点的各个组成部分。通过邮寄访谈、电话随访和查阅医院病历获得随访资料。

结果

DES组和BMS组在年龄（71±8岁 vs. 70±7岁，P = 1.0）、糖尿病（45% vs. 36%，P = 0.3）、心肌梗死病史（58% vs. 51%，P = 0.6）、射血分数（EF）（44% vs. 47%，P = 0.2）和既往经皮冠状动脉介入治疗（PCI）（40% vs. 35%，P = 0.4）方面相似。DES组的参考血管直径（3.15±0.5 mm vs. 3.5±0.5 mm，P = 0.001）和支架尺寸（3.3±0.4 mm vs. 3.9±0.5 mm，P = 0.001）较小；然而，BMS更长（24±10 mm vs. 21±6 mm，P = 0.05）。1年时，DES组的MACE发生率有降低趋势（P = 0.1），但2年时，DES组和BMS组的无MACE生存率无差异（81% vs. 82%，P = 0.9）。死亡率相似（均为6%），有3例患者发生STEMI（DES组2例，BMS组1例）。TVR也相似（每组均为14%）。