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目的与传统对称性、永久性涂层雷帕霉素洗脱支架(SES)比较,评价新型非对称、可降解涂层SES应用于行直接经皮冠状动脉介入治疗(PCI)急性ST段抬高型心肌梗死(STEMI)患者的安全性和有效性。方法连续收集2007年1月—2009年12月行直接PCI的STEMI患者,将单纯植入新型非对称、可降解涂层SES的171例患者纳入研究组,单纯植入传统对称性、永久性涂层SES的249例患者纳入对照组。在术后1年时对两组患者进行临床随访。结果研究组和对照组患者的主要研究终点(1年期靶病变失败)的发生率分别为5.8%和5.6%,两组间差异无统计学意义(P>0.05)。两组间全因死亡、心源性死亡、非致死性再次心肌梗死、靶血管血运重建和靶血管失败等各项次要研究终点指标的差异也均无统计学意义(P值均>0.05)。术后随访1年,研究组发生1例亚急性支架内血栓,对照组发生3例亚急性支架内血栓和1例晚期支架内血栓,两组间差异无统计学意义(P>0.05)。两组患者的1年期主要不良心脏事件(MACE)发生率的差异也无统计学意义(P>0.05)。结论新型非对称、可降解涂层SES在行直接PCISTEMI患者的中期有效性和安全性与传统SES相当,其远期效果有待进一步研究。
OBJECTIVE: To evaluate the efficacy and safety of novel asymmetric, biodegradable coating SES for acute percutaneous transluminal coronary angioplasty (PCI) with acute ST-segment elevation compared with traditional symmetrical and permanent coated rapamycin-eluting stent (SES) Safety and efficacy in patients with acute myocardial infarction (STEMI). Methods A total of 171 consecutive patients with STEMI who underwent direct PCI between January 2007 and December 2009 were enrolled in the study. 171 patients were enrolled in the study. The patients were implanted with traditional symmetry and permanent coating 249 patients with SES were included in the control group. One year after surgery, two groups of patients were followed up. Results The incidence of primary study endpoint (1-year target disease failure) in study group and control group was 5.8% and 5.6% respectively, with no significant difference between the two groups (P> 0.05). There was also no significant difference between the two groups in all the secondary endpoints of all-cause mortality, cardiogenic death, non-fatal myocardial infarction, target revascularization and target vessel failure (P> 0.05 ). One year after the operation, subacute stent thrombosis occurred in the study group and subacute stent thrombosis occurred in the control group. One case of late stent thrombosis occurred in the control group. There was no significant difference between the two groups (P> 0.05). There was also no significant difference in the incidence of major adverse cardiac event (MACE) between the two groups in one year (P> 0.05). Conclusions The new asymmetric, biodegradable coating SES is comparable to traditional SES in terms of mid-term efficacy and safety in direct PCISTEMI patients and its long-term efficacy needs further study.