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目的比较急性ST段抬高心肌梗死(STEMI)应用Firebird支架和金属裸支架的安全性和有效性。方法入选2005年1月至12月的STEMI患者,随机置入Firebird或金属裸支架(BMS),进行临床和造影随访研究。本研究一级终点是6个月的靶病变晚期管腔丢失(ILL),次级终点包括6个月的支架内血栓形成率和主要心脏不良事件(MACE)。结果1年中,共入选156例患者,Firebird组101例(平均57.78岁),BMS组55例(平均59.69岁)。Firebird组和BMS组的6个月造影随访率分别是66.3%和63.7%。6个月随访期中,Firebird组的MACE发生率显著低于BMS组(5.0% vs 30.9%,P<0.01)。这种降低与靶血管重建率(TVR)明显下降有关(3% vs 27.3%,P<0.01)。两组的死亡率差异无统计学意义(2.0% vs 3.6%,P>0.05)。两组各有1例亚急性血栓形成。Firebird组的平均ILL(0.18 mm)明显低于BMS组(0.72 mm)。结论STEMI患者应用Firebird支架可以大为降低6个月的TVR率和MACE率;相比BMS,其急性/亚急性支架内血栓发生率没有增加的趋势。
Objective To compare the safety and efficacy of Firebird stent and bare metal stent in acute ST-segment elevation myocardial infarction (STEMI). Methods STEMI patients enrolled in January-December 2005 were randomized to either Firebird or bare metal stent (BMS) for clinical and radiographic follow-up studies. The primary end point of this study was late-stage target luminal loss (ILL) at 6 months. The secondary end point included a 6-month rate of stent thrombosis and major adverse cardiac events (MACE). Results One year, a total of 156 patients were enrolled. There were 101 Firebird patients (mean 57.78 years) and 55 patients (average 59.69 years) in the BMS group. The 6-month follow-up rates for the Firebird and BMS groups were 66.3% and 63.7%, respectively. In the 6-month follow-up period, the incidence of MACE in Firebird group was significantly lower than that in BMS group (5.0% vs 30.9%, P <0.01). This decrease was associated with a significant reduction in target vessel remodeling (TVR) (3% vs 27.3%, P <0.01). There was no significant difference in mortality between the two groups (2.0% vs 3.6%, P> 0.05). There was 1 subacute thrombosis in each group. The mean ILL (0.18 mm) for the Firebird group was significantly lower than for the BMS group (0.72 mm). Conclusion The application of Firebird stent in STEMI patients can greatly reduce the TVR rate and MACE rate in 6 months. There is no increase in the incidence of acute / subacute stent thrombosis compared with BMS.