目的：比较药物洗脱支架（DES）治疗支架内再狭窄病变（ISR）与冠状动脉原发病变（De novo）患者的长期临床疗效。方法收集2008年10月至2011年11月在北京安贞医院因ISR接受DES置入治疗的患者作为试验组（ISR组），选择同期因冠状动脉原发病变（De novo）置入DES治疗的患者作为对照组（De novo组）。比较两组患者1年的主要不良心血管事件（MACE），包括全因死亡、心肌梗死（MI）和靶病变血运重建（TLR）。结果204例患者入选ISR组，494例患者入选De novo组。ISR组糖尿病患病率明显高于De novo组（36.6%比27.1%，P＜0.05），ISR组不稳定型心绞痛比例明显低于De novo组（26.0%比70.6%，P＜0.01），其余基线资料差异无统计学意义（P＞0.05）；两组在病变部位、病变类型、病变特点方面比较，差异均无统计学意义（P＞0.05），而ISR组支架直径明显小于De novo组，差异有统计学意义[（2.72±0.36）mm比（3.08±0.54）mm，P＜0.01）。ISR组MACE发生率明显高于De novo组（21.1%比14.2%，P＜0.05），其中，ISR组TLR明显高于De novo组（17.2%比10.7%，P＜0.05）。结论 DES治疗ISR患者安全有效，但与治疗冠状动脉原发病变比，TLR明显升高。%Objective Compare the efifcacy and safety of drug eluting stent (DES) for treatment of in stent restenosis (ISR) and coronary de novo lesions. Methods Patients treated with DES for ISR and de novo lesions in Beijing Anzhen Hospital between October 2008 and December 2011 were followed up for 1 year. All lesions were divided into ISR and de novo group. Major adverse cardiovascular events (MACE) including all-cause death, myocardial infarction (MI) and clinical target lesion revascularization (TLR) were the primary endpoints. Results The study population consisted of 204 patients in the ISR group and 494 patients in the de novo group. Baseline clinical and angiographic parameters were comparable between the two groups. The rate of diabetic was higher in the ISR group than that in the de novo group (36.6%to 27.1%, P < 0.05). The diameter of coronary artery was smaller in the ISR group than that in the de novo group (2.72±0.36 to 3.08±0.54, P<0.01). The rate of TLR in the ISR group was higher than that in the de novo group (10.7%to 17.2%, P<0.05;14.2%to 21.1%, P<0.05),contributing to higher MACE in ISR group. Conclusions DES implantation is safe and effective for treatment of ISR lesions, but the rate of TLR is higher compared to treatment of de novo lesions.
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