药物洗脱支架治疗完全闭塞病变的疗效观察

The Long-Term Efficacy of Drug-Eluting Stent for the Treatment of Chronic Total Occlusion

目的:评估在冠心病患者,不同药物洗脱支架对于治疗冠状动脉完全闭塞病变的远期疗效。方法:122例完全闭塞病变[冠状动脉溶栓治疗临床试验(TIMI)0级血流,且闭塞时间>3个月]并成功置入Firebird支架(Firebird组,n=58)、Cypher支架(Cypher组,n=40)和Taxus支架(Taxus组,n=24)的患者入选本研究。术后12个月随访时进行定量冠状动脉造影分析,并观察住院期间,30天和12个月时不良心脏事件的发生和靶病变重复血管重建。结果:3组的基本临床特征和基础冠状动脉造影结果相似,支架置入成功率均为100。术后支架内最小管腔直径,3组间差异无统计学意义(P>0.05)。住院期间3组均无靶病变重复血管重建和死亡发生。在30天时,3组均无支架内血栓形成。12个月随访期间,严重不良心脏事件发生率和靶病变重复血管重建率,在Firebird组为5.2和3.4;Cy-pher组为10.0和5.0,其中死亡1例(2.5);Taxus组为12.5和12.5,均无显著性差异(P>0.05)。12个月定量冠状动脉造影分析显示:支架内最小管腔直径和管腔狭窄直经,在Firebird组和Cypher组无显著差异(P>0.05),但Taxus组与Firebird组和Cypher组比较均有显著差异(P<0.05)。同时支架内远期管腔丢失Firebird组和Cypher组也明显低于Taxus组(P<0.05)。Firebird组、Cypher组和Taxus组支架内再狭窄率分别为5.17,10.0和20.83,其中Taxus组2例发生支架内再闭塞(8.3),均无显著性差异。结论:在慢性完全闭塞病变患者,使用药物洗脱支架安全有效,且急性并发症发生率低。经雷帕霉素药物支架治疗患者再狭窄率及再闭塞率较低。

Objective：To assess the long-term treatment efficacy of drug-eluting stent Sirolimus （SES）, Paclitaxel （PES）and Firebird （Home-made Sirolimus,FB）on patients with chronic total occlusion（CTO）. Methods ：122 patients with CTO（58 FB,40 SES,24 PES）in native coronary arteries（defined as TIMI flow grade 0 and the occlusion time was more than 3 months）were included in the study and were perfot^med analysis after successful recanalization of CTO. Angiograms were analyzed by quantitative coronary angiography（QCA） post-procedure and at a 12-month follow-up. Patients were observed for major adverse cardiac events （MACE）and target lesions revascularization（TLR） during hospitalization, at the 30 days and 12 months follow-up. Results：Baseline characteristics were similar among 3 groups. The ratio of procedural success was 100% in 3 groups. There was no significant difference in MLD among 3 groups（ P 〉 0.05 ）. There were no target lesion revascularization（TLR） and death during hospitalization in 3 groups. At the 30 days, no stent thromboses were observed in 3 groups. During 12-months clinical follow-up,MACE and TLR were not different in 3 groups （ FB 5.2% and 3.4% ; SES 10. 0% and 5.0% ; PES 12. 50% and 12.5% ）. QCA at 12 months follow-up revealed a significantly larger minimal lumen diameter （2.18 ±0. 38 mm vs 1.82 ± 0. 81 ram;2. 24 ±0. 55 mm vs 1.82 ±0. 81 mm,P 〈0.05）in lesions treated with FB and SES compared to PES. Similarly,lumen late loss was significantly higher in the PES group compared with FB and SES groups（0. 62 ±0. 76 mm vs 0. 16 ±0. 22 ram;0.62 ±0. 76 mm vs 0. 24 ± 0. 51 mm;P 〈 0. 05）. Binary in stent restenosis rate were not significant difference （5. 17%, 10. 0%, 20. 83% ,P 〉0.05）. Conclusion：The use of drug-eluting stents in patients with CTO was safe and effective with few acute complication. Patients treated with SES and FB showed lower rate of restenosis.