药物洗脱支架在冠心病介入治疗中的有效性与安全性研究

Effectiveness and safety of drug-eluting stents in percutaneous coronary intervention of patients with coronary artery disease

目的评价药物洗脱支架在冠心病介入治疗中的有效性和安全性。方法回顾性分析复旦大学附属华山医院心内科2003年11月～2006年12月应用药物洗脱支架的346例冠心病患者，收集15～52个月的临床资料，评价经皮冠脉介入治疗（PCI）术后临床症状的改善情况；主要心脏不良事件（MACE）。MACE包括心源性死亡、非致命性心肌梗死和靶血管重建（TVR）；其中72例复查冠脉造影，对其支架内再狭窄、支架内血栓形成、靶血管动脉瘤的发生率进行统计分析。结果346例冠心病患者共成功植入药物洗脱支架674枚，PCI术后207例患者临床症状完全缓解，109例患者的临床症状明显改善，临床症状缓解率达91．3％。DES植入术后住院期间MACE发生率为0．9％（3／346），院外随访期间MACE发生率为3．7％（11／346）。冠状动脉造影复查发现晚期支架内血栓形成发生率为0．8％（1／132）；靶血管动脉瘤形成0．8％（1／132）；支架内再狭窄发生率为4．5％（6／132），其中4例再次于靶病变处植入DES。PCI术后应用双联抗血小板药物过程中的出血并发症37例，白细胞减少2例。结论药物洗脱支架在冠心病介入治疗中应用是安全、有效的，MACE、支架内再狭窄和支架内血栓形成的发生率很低。

Objective Safety of drug-eluting stents has aroused much attention due to increased intra-stent thrombosis, myocardial infarction and death in clinical practices. The goals of our study were to determine the effectiveness and safety of drug-eluting stents in patients with coronary artery disease （CAD） who underwent percutaneous coronary intervention. Methods A total of 346 CAD patients who underwent drug-eluting stents were retrospectively analyzed in the department of cardiology of Huashan hospital from November 2003 to December 2006. Overall clinical data （15-52 months） were generally obtained to assess the clinical effectiveness and major adverse cardiac events （MACE） including cardiac death, non-fatal myocardial infarction and target vessel revascularization （TVR）. Clinical follow-up in-stent restenosis （ISR）, late intra-stent thrombosis and stent aneurysm of the target vessel were analyzed by coronary angiography again in 72 patients. Results Of the 346 CAD who were successfully treated with 674 drug-eluting stents by means of percutaneous coronary intervention, the symptoms were relieved in 207 patients, and improved in 109 patients, with an overall effective rate of 91.3%. The overall MACE rate during hospitalization was 0.9% （3/346）, and 3.7% （11/346） during the long-term follow-up period. Late intra-stent thrombosis （1/132） and stent aneurysm of the target vessel （ 1/132 ） were analyzed by coronary angiography again in 72 patients. The re-stenosis rate of DES was 4.5% （6/132）, of which four DES were implanted in the target vessel according to standard procedure. Hemorrhagic complications （37/346） and leukocytopenia （2/346） were observed during prolonged dual antiplatelet therapy. Condusion Drug-eluting stents are relatively safe and effective in CAD patients. The incidence of MACE and ISR is low.