国产Firebird支架的远期安全性和有效性研究

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.

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

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.