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目的:评估药物洗脱支架与金属裸支架对于治疗冠状动脉临界病变的远期疗效。方法:自身冠状动脉首次介入治疗病变(在线定量冠状动脉造影分析50%≤管腔狭窄直径≤70%)的患者入选本研究,共计151例患者分为药物洗脱支架组(n=102)和金属裸支架组(n=49),两组的基本临床特征和冠状动脉造影结果差异无统计学意义。术前、术后和随访6～12个月时进行定量冠状动脉造影分析,并在住院期间、30天和6～12个月时观察严重不良心脏事件的发生。结果:151例患者支架置入成功率均为100%。住院期间严重不良心脏事件发生率,在药物洗脱支架组和金属裸支架组差异无统计学意义(0%和2.0%,P=0.15)。在随访30天时,两组均无死亡和支架内血栓形成。6～12个月随访期间,药物洗脱支架组和金属裸支架组比较①严重不良心脏事件发生率(3.9%vs8.1%,P=0.97),②靶病变重复血管重建率(2.9%vs6.1%,P=0.39),③急性心肌梗死发生率(1.96%vs2.04%,P=0.95),差异均无统计学意义。12个月时药物洗脱支架组和金属裸支架组比较,支架内血栓发生率和病死率差异也无统计学意义(1.96%vs0%,P=0.34;0%vs4.08%,P>0.05)。定量冠状动脉造影分析显示:远期管腔丢失药物洗脱支架组明显低于金属裸支架组[(0.23±0.73)mmvs(0.95±0.94)mm,P=0.01],两组比较差异有统计学意义;而支架内再狭窄率两组比较差异无统计学意义(12.9%vs25.0%,P=0.34)。结论:药物洗脱支架和金属裸支架对于治疗自身冠状动脉临界病变安全有效,两组远期严重不良心脏事件发生率差异无统计学意义。
OBJECTIVE: To evaluate the long-term efficacy of drug-eluting stents and bare metal stents in the treatment of critical coronary artery disease. METHODS: Patients undergoing PCI for the first time in their study (50% of patients undergoing coronary angiography ≤70% of stenosis) were enrolled in this study. A total of 151 patients were enrolled in the DES (n = 102) and In the bare metal stent group (n = 49), there was no significant difference between the two groups in the basic clinical features and the results of coronary angiography. Coronary angiography was performed preoperatively, postoperatively, and at 6-12 months of follow-up, and serious adverse cardiac events were observed during hospitalization, 30 days, and 6-12 months. Results: The success rate of stent implantation in 151 patients was 100%. The incidence of serious adverse cardiac events during hospitalization was not statistically different between the drug-eluting stent group and the bare-metal stent group (0% and 2.0%, P = 0.15). At 30 days of follow-up, there was no death or stent thrombosis in both groups. The incidences of serious adverse cardiac events (3.9% vs 8.1%, P = 0.97), ②the rate of target vessel recanalization (2.9% vs6 .1%, P = 0.39), ③ the incidence of acute myocardial infarction (1.96% vs 2.04%, P = 0.95), the difference was not statistically significant. At 12 months, there was no significant difference in the incidence of stent thrombosis or mortality between the drug-eluting stent group and the bare metal stent group (P <0.34; 0% vs 4.08%, P> 0.05 ). Quantitative coronary angiography showed that the long-term lumen loss in the drug-eluting stent group was significantly lower than that in the bare metal stent group (0.23 ± 0.73 mmres vs 0.95 ± 0.94 mm, P = 0.01), and the differences between the two groups were statistically significant However, there was no significant difference between the two groups in restenosis rate (12.9% vs 25.0%, P = 0.34). Conclusions: The drug-eluting stent and bare metal stent are safe and effective in treating the critical coronary artery disease of their own. There was no significant difference in the incidence of serious adverse cardiac events between the two groups.