A comparison of bare-metal and drug-eluting stents for off-label indications
A comparison of bare-metal and drug-eluting stents for off-label indications
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DOI：
10.1056/nejmoa0706258
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发表时间：
2008-01-24
影响因子：
158.5
通讯作者：
Kip, Kevin E.
中科院分区：
文献类型：
--
作者：
Marroquin, Oscar C.;Selzer, Faith;Kip, Kevin E.
背景：最近的报告表明，药物洗脱支架的标签外使用与不良事件的发生率增加有关。裸金属支架的使用是否会产生不同的结果是unknown.Methods：我们分析了6551例患者在国家心脏，肺，血液研究所动态注册根据他们是否接受药物洗脱支架或裸金属支架治疗，是否使用标准或标签外。随访患者1年，观察心血管事件和死亡的发生情况。标签外使用定义为用于再狭窄病变、旁路移植术中的病变、左主干冠状动脉疾病或开口、分叉或完全闭塞病变，以及用于参考血管直径小于2.5 mm或大于3.75 mm或病变长度大于30 mm的患者。54.7%的裸金属支架患者和48.7%的药物洗脱支架患者发生标签外使用。与裸金属支架患者相比，药物洗脱支架患者糖尿病、高血压、肾脏疾病、既往经皮冠状动脉介入治疗和冠状动脉旁路移植术以及多支冠状动脉疾病的患病率更高。然而，介入治疗后一年，与裸金属支架组相比，药物洗脱支架组患者的死亡或心肌梗死校正风险无显著差异，而药物洗脱支架组患者的再次血运重建风险显著降低。在标签外适应症患者中，使用药物-洗脱支架与死亡或心肌梗死风险增加无关，但与重复血运重建率降低相关1年时，与裸金属支架相比。这些发现支持药物洗脱支架用于标签外适应症。
Background: Recent reports suggest that off-label use of drug-eluting stents is associated with an increased incidence of adverse events. Whether the use of bare-metal stents would yield different results is unknown.Methods: We analyzed data from 6551 patients in the National Heart, Lung, and Blood Institute Dynamic Registry according to whether they were treated with drug-eluting stents or bare-metal stents and whether use was standard or off-label. Patients were followed for 1 year for the occurrence of cardiovascular events and death. Off-label use was defined as use in restenotic lesions, lesions in a bypass graft, left main coronary artery disease, or ostial, bifurcated, or totally occluded lesions, as well as use in patients with a reference-vessel diameter of less than 2.5 mm or greater than 3.75 mm or a lesion length of more than 30 mm.Results: Off-label use occurred in 54.7% of all patients with bare-metal stents and 48.7% of patients with drug-eluting stents. As compared with patients with bare-metal stents, patients with drug-eluting stents had a higher prevalence of diabetes, hypertension, renal disease, previous percutaneous coronary intervention and coronary-artery bypass grafting, and multivessel coronary artery disease. One year after intervention, however, there were no significant differences in the adjusted risk of death or myocardial infarction in patients with drug-eluting stents as compared with those with bare-metal stents, whereas the risk of repeat revascularization was significantly lower among patients with drug-eluting stents.Conclusions: Among patients with off-label indications, the use of drug-eluting stents was not associated with an increased risk of death or myocardial infarction but was associated with a lower rate of repeat revascularization at 1 year, as compared with bare-metal stents. These findings support the use of drug-eluting stents for off-label indications.