Kim Yong Hoon, Her Ae-Young, Rha Seung-Woon, Choi Byoung Geol, Choi Se Yeon, Byun Jae Kyeong, Baek Ju Yeol, Choi Woong Gil, Kang Tae Soo, Ahn Ji Hoon, Park Sang-Ho, Mashaly Ahmed, Na Jin Oh, Choi Cheol Ung, Lim Hong Euy, Kim Eung Ju, Park Chang Gyu, Seo Hong Seog, Oh Dong Joo
Division of Cardiology, Department of Internal Medicine, Kangwon National University School of Medicine, Chuncheon, South Korea.
Cardiovascular Center, Korea University, Guro Hospital, Seoul, South Korea.
J Geriatr Cardiol. 2018 Aug;15(8):523-533. doi: 10.11909/j.issn.1671-5411.2018.08.006.
There were limited data comparing the major clinical outcomes between first-generation (1G)-drug eluting stents (DES) and second-generation (2G)-DES in patients with acute myocardial infarction (AMI) after percutaneous coronary intervention (PCI) during very long follow-up periods. We thought to investigate the comparative efficacy and safety of 2G-DES compared with 1G-DES in AMI patients during 5-year follow-up periods.
A total of 1016 eligible AMI patients who underwent PCI with 1G-DES [paclitaxel-, sirolimus-, 1G-zotarolimus-eluting stent (endeavor or endeavor sprint), = 554] or 2G-DES [2G-zotarolimus (endeavor resolute)- or everolimus-eluting stent, = 462] were enrolled. The primary endpoint was the occurrence of major adverse cardiac events (MACE) defined as total death, non-fatal myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), non-target vessel revascularization (Non-TVR) and the secondary endpoint was stent thrombosis (ST) at 5 years.
Two propensity score-matched (PSM) groups (232 pairs, = 464, C-statistic = 0.802) were generated. During the 5-year follow-up period, the cumulative incidence of TLR [hazard ratio (HR): 3.133; 95% confidence interval (CI): 1.539-6.376; = 0.002], TVR (HR: 3.144; 95% CI: 1.596-6.192; = 0.001) and total revascularization rate (HR: 1.874; 95% CI: 1.086-3.140; = 0.023) were significantly higher in 1G-DES compared with 2G-DES after PSM. However, the incidence of total death, non-fatal MI and ST were similar between the two groups.
In this single-center and all-comers registry, 2G-DES's superiorities for TLR, TVR and total revascularization in AMI patients suggested during 5-year clinical follow-up periods.
在很长的随访期内,关于第一代(1G)药物洗脱支架(DES)与第二代(2G)DES用于急性心肌梗死(AMI)患者经皮冠状动脉介入治疗(PCI)后的主要临床结局对比的数据有限。我们旨在研究2G-DES与1G-DES在AMI患者5年随访期内的疗效和安全性差异。
共纳入1016例符合条件的接受PCI治疗的AMI患者,其中554例植入1G-DES[紫杉醇、西罗莫司、1G-佐他莫司洗脱支架(安珂或安珂快速型)],462例植入2G-DES[2G-佐他莫司(安珂坚定型)或依维莫司洗脱支架]。主要终点为主要不良心脏事件(MACE)的发生,定义为全因死亡、非致死性心肌梗死(MI)、靶病变血运重建(TLR)、靶血管血运重建(TVR)、非靶血管血运重建(非TVR);次要终点为5年时的支架血栓形成(ST)。
生成了两个倾向评分匹配(PSM)组(232对,共464例,C统计量 = 0.802)。在5年随访期内,PSM后1G-DES组的TLR[风险比(HR):3.133;95%置信区间(CI):1.539 - 6.376;P = 0.002]、TVR(HR:3.144;95% CI:1.596 - 6.192;P = 0.001)和总血运重建率(HR:1.874;95% CI:1.086 - 3.140;P = 0.023)显著高于2G-DES组。然而,两组间的全因死亡、非致死性MI和ST发生率相似。
在这个单中心、纳入所有患者的注册研究中,5年临床随访期显示2G-DES在AMI患者的TLR、TVR和总血运重建方面具有优势。