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目的探讨直接国产雷帕霉素洗脱支架与裸支架治疗AuI临床疗效的差异．方法将173例连续行直接PCI的AMI患者随机分为雷帕霉素洗脱支架组(87例)和裸支架组(86例),分析住院期间和6个月的支架内血栓,主要心血管事件(包括再次心肌梗死、缺血性靶血管重建和死亡)发生率及6个月再狭窄率。结果两组患者在术后血管通畅、CPK峰值、心功能和住院期间心脏事件方面的差异均无统计意义(P值均>0．05)。两组各有2例支架内血栓(2．4％比2．3％,P>0．05)。6个月时,国产雷帕霉素洗脱支架组的支架内再狭窄率(4．5％比40％,P<0.01)、节段内再狭窄率(6．8％比44．9％,P<0．01)和主要心脏事件发生率(8．0％比22．4％,P<0．05)均显著低于裸支架组。国产雷帕霉素洗脱支架组主要心脏事件的减少主要由因为缺血性靶血管重建减少所致(3．4％比11．6％,P<0．05)结论与裸支架相比,国产雷帕霉素洗脱支架治疗AMI患者并未增加支架内血栓的发生,并且能显著降低6个月的再狭窄率和主要心脏事件发生率。
Objective To investigate the clinical efficacy of direct domestic rapamycin eluting stent and bare stent in the treatment of AuI. Methods 173 consecutive AMI patients undergoing direct PCI were randomly divided into rapamycin eluting stent group (n = 87) and bare metal stent group (n = 86). The stent thrombosis during the hospitalization and 6 months were analyzed. The main cardiovascular Incidence (including recurrent myocardial infarction, ischemic target revascularization and death) and incidence of 6-month restenosis. Results There was no significant difference in postoperative vascular smoothness, peak CPK, cardiac function and cardiac events during hospitalization (P> 0.05). There were 2 cases of stent thrombosis in each group (2.4% vs 2.3%, P> 0.05). At 6 months, the rate of in-stent restenosis (4.5% vs. 40%, P <0.01), intra-articular restenosis (6.8% vs. 44.9% , P <0.01) and the incidence of major cardiac events (8.0% vs. 22.4%, P <0.05) were significantly lower than those in the bare-metal stent group. The decrease in major cardiac events in the domestic rapamycin-eluting stent group was mainly due to a decrease in ischemic target vessel remodeling (3.4% versus 11.6%, P <0.05). Conclusions Compared with bare-metal stents, The domestic rapamycin-eluting stent treatment of AMI patients did not increase the incidence of stent thrombosis, and can significantly reduce the 6-month restenosis rate and the incidence of major cardiac events.