新型非对称、可降解涂层雷帕霉素洗脱支架用于行直接经皮冠状动脉介入治疗的急性心肌梗死患者的疗效和安全性

Efficacy and safety of a novel non-symmetrical,biodegradable polymer-coated sirolimus-eluting stent in patients with acute myocardial infarction undergoing primary percutaneous coronary intervention

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 compare a novel non-symmetrical, biodegradable polymer-coated sirolimuseluting stent （NSBP-SES） with a traditional symmetrical, durable polymercoated sirolimus-eluting stent （SDP- SES） during percutaneous coronary intervention （PCI）, and to evaluate its efficacy and safety in patients with ST- segment elevation myocardial infarction （STEMI）. Methods From January 2007 to December 2009, NSBP-SES was implanted in 171 patients （experimental group） and SDP-SES in 249 patients （control group） during primary PCI for STEMI. All the patients were followed up for one year postoperatively, Results There was no significantdifference in the incidence rate of 12-month target lesion failure （TLF） between experimental group and control group （5.8% vs. 5.6%, P〉0.05） ; neither were the death, cardiac death, non-fatal re-infarction, target vessel revascularization, or target vessel failure （all P 〉 0. 05）. Subacute stent thrombosis occurred in 1 patient in experimental group and in 3 patients in control group. Late stent thrombosis occurred in another patient in control group. Conclusion There are no significant differences in efficacy and safe between NSBP-SES and SDP-SES durinq primary PCI for STEMI. Further investigation is warranted to validate the long-term clinical outcomes.（Shanghai Med J, 2012, 35： 44-47）