国产Firebird支架的远期安全性和有效性研究  

Study of long-term safety and efficacy of domestic Firebird rapamyein-eluting stent

作　　者：叶显华[1] 王宁夫[1] 郭士遵[1] 周亮[1] 徐坚[1] 童国新[1] 杨建敏[1] 

机构地区：[1]杭州市第一人民医院心内科,310006

出　　处：《中华老年医学杂志》2010年第11期920-923,共4页Chinese Journal of Geriatrics

基　　金：杭州市社会发展科技攻关计划（20070733804）

摘　　要：目的 观察国产Firebird西罗莫司涂层支架治疗冠心病的远期安全性和治疗效果.方法 465例接受介入治疗的冠心病患者,由患者自主选择应用国产Firebird支架或进口Cypher支架,随访观察可能的不良事件和治疗效果,随访时间不少于24个月. 结果 Firebird组321例,随访观察（45.3±11.1）个月,其中166例（51.7%）复查冠状动脉造影,Cypher组144例,随访观察（46.1±12.1）个月,其中82例（56.3%）复查冠状动脉造影.随访结束时,两组间全因死亡（7.8%和7.6%）（x2=1.32,P=0.250）、心源性死亡（5.9%和5.6%）（x2=0.02,P=0.877）、急性心肌梗死（2.8%和3.4%）（x2=0.15,P=0.697）、因心血管事件再入院率（29.6%和31.9%）（x2=0.26,P=0.610）、急性和亚急性血栓事件（0.9%和1.3%）（x2=0.19,P=0.661）、晚期血栓事件（L 2%和1.3%）（x2=0.02,P=0.900）、靶病变再次血运重建术（3.4%和4.2%）（x2=0.15,P=0.694）差异均无统计学意义. 结论 国产Firebird西罗莫司涂层支架与进口Cypher西罗莫司涂层支架有相同或近似的远期安全性和有效性.Objective To evaluate the long-term safety and efficacy of domestic Firebird rapamycin-eluting stent in treatment of patients with coronary artery disease （CAD）. Methods The 465 patients with CAD received percutaneous interventional therapy with domestic Firebird or imported Cypher rapamycin-eluting stent based on patients＇ will and they were followed up for more than 24 months. Results The 321 cases in Firebird group were followed up for （45.3 ±11.1）months, with 166 cases （51.7%） received reexamination by coronary angiography. The 144 patients in Cypher group were followed up for （46.1 ± 12. 1） months, with 82 patients （56.3%） received reexamination by coronary angiography. At the termination of follow-up, there were no significant differences in all-cause death （7.8% vs. 7.6 %, x2 = 1.32, P = 0. 250）, cardiac death （5.9% vs.5.6%, x2 =0. 02, P=0. 877）, acute myocardial infarction （2.8% vs. 3.4%, x2 =0. 15, P=0. 697）,cardiovascular-cause rehospitalization （29.6% vs. 31.9 %, x2 =0.26, P=0. 610）, acute and subacute thrombosis events （0.9% vs. 1.3%, x2 =0.19, P=0.661）, late thrombotic events （1.2% vs.1.3%, x2 =0. 02, P=0. 900） and target lesion revascularization （3.4% vs. 4.2%, x2 =0. 15, P=0. 694） between two groups. Conclusions Domestic Firebird rapamycin-eluting stent has the same or similar long-term safety and efficacy with imported Cypher rapamycin-eluting stent.

关 键 词：冠状动脉疾病 支架 安全 设备 治疗效果 随访研究 

分 类 号：R686[医药卫生—骨科学]