药物洗脱支架与金属裸支架对非糖尿病患者冠状动脉局限病变的8个月疗效

The Long-Term Efficacy of Drug-Eluting Stent Versus Bare Metal Stent in Coronary Local Lesions Patients of Non-Diabetes

目的:评估非糖尿病冠心病患者,药物洗脱支架与金属裸支架对于治疗冠状动脉局限病变的8个月疗效。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直径≥3.0 mm,长度≤15 mm)的非糖尿病患者入选本研究,148例患者分为约物洗脱支架组(n=81)和金属裸支架组(n=67),两组的基本临床特征和冠状动脉造影结果无显著差异。术前、术后和8个月随访时进行定量冠状动脉造影分析,并在住院期间,30天和8个月时观察不良心脏事件的发生。结果:支架置入成功率均为100%。住院期间靶病变重复血管重建率,在药物洗脱支架组和金属裸支架组无显著性差异(1.2%和0%,P=0.36)。在术后30天时两组均无支架内血栓形成。8个月随访时,定量冠状动脉造影分析显示,支架内最小管腔直径:药物洗脱支架组明显大于金属裸支架组,有极显著性差异(P<0.01);支架内远期管腔丢失、病变内远期管腔丢失、支架内狭窄直径、病变内狭窄直径:药物洗脱支架组明最低于金属裸支架组有显著性差异(P<0.05～0.001)。两组支架内再狭窄率(8.64% vs 17.91%,P=0.09)和病变节段再狭窄率(11.11% vs 17.91%,P=0.24)均无显著性差异,但支架内再狭窄率比数比为0.8985(95%的可信区间0.7887;1.0237)。结论:药物洗脱支架对于治疗非糖尿病、自身冠状动脉局限病变患者安全有效,两组支架内再狭窄率虽无显著性差异,但药物洗脱支架有降低再狭窄率的趋势。

Objective：To assess the long-term efficacy of drug-eluting stent versus bare metal stent for treatment of de novo native coronary local lesions in patients with non-diabetes. Methods ：Patients with de novo lesions in native coronary arteries （reference vessel diameter ≥ 3.0mm, lesion length ≤ 15mm） were eligible for the study. 148 patients were assigned treatment with a drug-eluting stent （ n = 81 ） or bare metal stent（ n = 67 ）. Angiograms were analyzed by quantitative coronary angiography （QCA） pre- and post-procedure as well as at 8-month follow-ut. Patients were followed for adverse cardiac events during hospital stay, at 30 days and 8 months. Results： Baseline characteristics were similar in both groups. Device success was 81 （ 100% ） in drug-eluting stent （DES） group and 67 （ 100% ） in the bare metal stent （BMS） group. There was one target lesion revascularization （TLR） during hospital stay in DES group. At 30 days, no stent thromboses were observed in either group. During clinical follow-up TLR and late stent thromboses were not different between the two groups（ 11.11% vs 17. 91% ,P =0. 24,1.2% vs 0% ,P =0. 36）. QCA at 8 months follow-up revealed a significantly larger minimal lumen diameter （2. 66 ± 0. 70mm vs 2. 28 ± 0. 74mm,P 〈 0. 001 ） and lower late loss （0. 36 ± 0. 69mm vs 0. 88 ± 0. 72mm ,P 〈 0. 0001 ）in lesions treated with DES group compared with BMS group. Binary in- stent and in segment restenosis rates of DES group were relatively lower compared with BMS （ 8. 64% vs 17.91% ,P = 0.09,OR =0.8985 and 11.11% vs 17.91% ,P=0. 24）. Conclusion ： Revascularization with DES is safe and effective in non-diabetic patients. Mthough the difference of binary restenosis rates was not significant between two groups ,there is a tendency for DES to lower restenosis rate.