Shishehbor Mehdi H, Hawi Riem, Singh Inder M, Tuzcu E Murat, Bhatt Deepak L, Ellis Stephen G, Kapadia Samir R
Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, OH 44114, USA.
Am Heart J. 2009 Oct;158(4):637-43. doi: 10.1016/j.ahj.2009.08.003.
Current data show conflicting results regarding safety and efficacy of drug-eluting stents (DES) versus bare-metal stents (BMS) for treating saphenous vein grafts (SVG). Our objective was to compare DES with BMS for SVG intervention.
Patients undergoing stenting with DES or BMS to SVG from January 2000 to June 2007 were included. To eliminate any unobserved bias regarding stent selection, the BMS cohort was divided into pre- and post-2003 when DES became available. Adjusted Cox analysis compared DES with pre- and post-2003 BMS patients. The primary end point was a composite of all-cause mortality, myocardial infarction, or target lesion revascularization.
Of the total 566 patients, 217 (38%) received DES, 110 (20%) received BMS post-2003, and 239 (42%) received BMS pre-2003. Median follow-up was 2.9 years (interquartile range 1.4-4.9 years). There was a trend toward lower primary end point with DES compared to post-2003 BMS (91 events, adjusted hazard ratio 0.61, 95% CI 0.35-1.07, P = .08). However, despite 179 events, DES use was not associated with lower primary end point compared with pre-2003 BMS (adjusted hazard ratio 0.61, 95% CI 0.28-1.35, P = .23).
Although DES showed a trend toward a lower primary end point when compared with BMS post-2003, this association was no longer present when DES was compared to pre-2003 BMS. These results are consistent with the preponderance of available data and indicate that unobserved bias in observational registries may explain the reported benefit of DES over BMS for treating SVG.
目前的数据显示,在药物洗脱支架(DES)与裸金属支架(BMS)治疗大隐静脉旁路移植血管(SVG)的安全性和有效性方面,结果相互矛盾。我们的目的是比较DES与BMS用于SVG介入治疗的效果。
纳入2000年1月至2007年6月期间接受DES或BMS置入术治疗SVG的患者。为消除支架选择方面任何未观察到的偏倚,将BMS队列分为2003年前和2003年后两组,2003年后DES开始应用。采用校正Cox分析比较DES与2003年前和2003年后的BMS患者。主要终点是全因死亡率、心肌梗死或靶病变血运重建的复合终点。
在总共566例患者中,217例(38%)接受DES,110例(20%)在2003年后接受BMS,239例(42%)在2003年前接受BMS。中位随访时间为2.9年(四分位间距1.4 - 4.9年)。与2003年后的BMS相比,DES组主要终点有降低趋势(91例事件,校正风险比0.61,95%可信区间0.35 - 1.07,P = 0.08)。然而,尽管有179例事件,与2003年前的BMS相比,使用DES与较低的主要终点无相关性(校正风险比0.61,95%可信区间0.28 - 1.35,P = 0.23)。
尽管与2003年后的BMS相比,DES显示出主要终点有降低趋势,但与2003年前的BMS相比时,这种相关性不再存在。这些结果与现有数据的优势一致,表明观察性注册研究中未观察到的偏倚可能解释了报告中DES治疗SVG优于BMS的益处。