Department of Cardiology, Medical Center Leeuwarden, PO Box 888, 8901 BR, Leeuwarden, the Netherlands,
Neth Heart J. 2014 Apr;22(4):167-73. doi: 10.1007/s12471-014-0525-0.
Everolimus-eluting stents (EES) were superior to sirolimus-eluting stents (SES) in a dedicated myocardial infarction trial, a finding that was not observed in trials with low percentages of ST-elevation myocardial infarction (STEMI). Therefore, this study sought to investigate the influence of clinical presentation on outcome after EES and SES implantation.
A pooled population of 1602 randomised patients was formed from XAMI (acute MI trial) and APPENDIX-AMI (all-comer trial). Primary outcome was cardiac mortality, MI and target vessel revascularisation at 2 years. Secondary endpoints included definite/probable stent thrombosis (ST). Adjustment was done using Cox regression.
In total, 902 EES and 700 SES patients were included, of which 44 % STEMI patients (EES 455; SES 257) and 56 % without STEMI (EES 447; SES 443). In the pooled population, EES and SES showed similar outcomes during follow-up. Moreover, no differences in the endpoints were observed after stratification according to presentation. Although a trend toward reduced early definite/probable ST was observed in EES compared with SES in STEMI patients, long-term ST rates were low and comparable.
EES and SES showed a similar outcome during 2-year follow-up, regardless of clinical presentation. Long-term safety was excellent for both devices, despite wide inclusion criteria and a large sub-population of STEMI patients.
依维莫司洗脱支架(EES)在心梗专病试验中优于西罗莫司洗脱支架(SES),而在 ST 段抬高型心肌梗死(STEMI)比例较低的试验中未观察到这一结果。因此,本研究旨在探讨临床发病情况对 EES 和 SES 植入术后结局的影响。
将 XAMI(急性 MI 试验)和 APPENDIX-AMI(所有患者试验)中的 1602 名随机患者合并为一个汇总人群。主要终点为 2 年时的心脏死亡率、心肌梗死和靶血管血运重建。次要终点包括明确/可能的支架血栓形成(ST)。采用 Cox 回归进行调整。
共纳入 902 名 EES 和 700 名 SES 患者,其中 44%为 STEMI 患者(EES 455 例,SES 257 例),56%无 STEMI(EES 447 例,SES 443 例)。在汇总人群中,EES 和 SES 在随访期间的结果相似。此外,根据临床表现进行分层后,终点事件也没有差异。尽管 STEMI 患者中 EES 组早期明确/可能 ST 的发生率较 SES 组有降低趋势,但长期 ST 发生率较低且相当。
无论临床发病情况如何,EES 和 SES 在 2 年随访期间的结果相似。尽管纳入标准广泛,STEMI 患者亚组较大,但两种器械的长期安全性均良好。