国产西罗莫司药物洗脱支架治疗冠心病331例的疗效及安全性

Clinical application of domestic rapamycin-eluting stents in coronary heart disease patients

目的探讨国产西罗莫司药物洗脱支架治疗冠心病的安全性与有效性。方法对331例冠心病患者采用经股动脉途径冠状动脉造影及常规方法行国产药物洗脱支架置入术，记录住院期间主要不良心脏事件（MACE）发生情况，术后1年随访，6-9个月行冠状动脉造影复查。结果331例冠心病患者共置入支架597只，均成功置入病变处；1例心源性休克行急诊经皮冠状动脉介入治疗（PC I）支架置入后3 h死于泵衰竭，1例发生血管破裂转外科行急诊冠状动脉旁路移植术，3例术后出现非Q波型心肌梗死，住院期间MACE发生率为1.5%。301例患者随访12.3±3.2个月，2例死亡，2例支架内血栓形成，1例非致死性心肌梗死，16例再次心绞痛发作，5例再次靶病变血运重建术，总的MACE发生率为4.3%；110例患者6-9个月行冠状动脉造影复查，6例支架内再狭窄，再狭窄率5.5%。结论国产西罗莫司药物洗脱支架治疗冠心病患者安全、有效，有较好的近、中期疗效和较高的效益/价格比，尤其适用于经济欠发达地区，可使更多冠心病患者受益；但其远期效果有待进一步研究。

Objective To evaluate the efficiency and safety of domestic rapamycin-eluting stent （Firebire stent） in the treatment of coronary heart disease. Methods Coronary angiography and stenting were carried out through femoral artery approach in 331 patients with coronary heart disease. The incidences of in-hospital major adverse cardiac events were recorded all the patients were followed up for 1 year. The follow-up angiography was carried out at at 6-9 months after discharge. Results A total of 597 domestic rapamycine-eluting stents were implanted in 331 patients. One patient died of pump failure after primary PCI and another patient required emergency CABG because of coronary artery rupture. NSTEMI happened in 3 patients after PCI. The incidence of in-hospital MACE was 1.5%. Three hundred and one patients finished a mean follow-up of 12. 3 ± 3.2 months. During the follow up period, non-fatal myocardial infrarction was recorded in 1 case, recurrent angina in 16 cases and target lesion revascularization in 5 cases. The overall MACE rate was 4.3%. Follow-up angiography was completed in 110 patients and the restenosis rate was 5.5% （6/110）. Conclusion Domestic rapamycin-eluting stent （Firebird stent） was safe and effective in the treatment of coronary heart disease and may provide a higher cost-effectiveness due to its relatively low price. However, its long-term effect needs more studies to verify.