Department of Cardiology, Nagoya Heart Center, Nagoya, Japan.
J Interv Cardiol. 2020 Apr 20;2020:2869303. doi: 10.1155/2020/2869303. eCollection 2020.
Our aim was to evaluate the safety and efficacy of biodegradable polymer everolimus-eluting stents (BP-EES) compared with durable polymer everolimus-eluting stents (DP-EES) in midterm.
There are few data about midterm clinical outcomes of BP-EES compared with DP-EES.
Between January 2016 and December 2017, 395 consecutive patients were treated with BP-EES and 391 consecutive patients were treated with DP-EES in Nagoya Heart Center. The primary endpoint was a 3-year cumulative incidence of target lesion failure (TLF) defined as cardiac death, target vessel myocardial infarction (MI), and clinical indicated target lesion revascularization (TLR). Moreover, clinical indicated target vessel revascularization (TVR) and definite stent thrombosis (ST) were also evaluated as the secondary endpoints. After propensity score matching, 327 patients were selected in each group. At 3 years, the cumulative incidence of TLF was 4.5% in the BP-EES group versus 6.5% in DP-EES (adjusted HR 0.67 (95% CI 0.33-1.30), log-rank =0.23). Regarding the individual components of the TLF at 3 years, the cumulative incidence of target vessel MI was significantly lower in BP-EES than in DP-EES (0% versus 1.9%: adjusted HR 0.83 (95% CI 0.71-0.97), log-rank =0.01), but there was no difference between BP-EES and DP-EES in the incidence of cardiac death and clinically indicated TLR. The cumulative 3-year incidence of definite ST was significantly lower in BP-EES than in DP-EES (0% versus 1.6%, log-rank =0.02).
There were no significant differences of TLF between BP-EES and DP-EES within 3 years. In this study, BP-EES seems to prevent definite ST and be safer than DP-EES in midterm.
本研究旨在评估生物可降解聚合物依维莫司洗脱支架(BP-EES)与持久性聚合物依维莫司洗脱支架(DP-EES)在中期的安全性和疗效。
与 DP-EES 相比,关于 BP-EES 的中期临床结果数据较少。
2016 年 1 月至 2017 年 12 月,在名古屋心脏中心连续入组 395 例接受 BP-EES 治疗的患者和 391 例接受 DP-EES 治疗的患者。主要终点为 3 年累积的靶病变失败(TLF)发生率,定义为心源性死亡、靶血管心肌梗死(MI)和临床指导的靶病变血运重建(TLR)。此外,还评估了临床指导的靶血管血运重建(TVR)和明确的支架血栓形成(ST)作为次要终点。在倾向评分匹配后,每组各选择 327 例患者。在 3 年时,BP-EES 组的 TLF 累积发生率为 4.5%,DP-EES 组为 6.5%(校正 HR 0.67(95%CI 0.33-1.30),log-rank =0.23)。关于 3 年时 TLF 的各个组成部分,BP-EES 组靶血管 MI 的累积发生率明显低于 DP-EES 组(0%比 1.9%:校正 HR 0.83(95%CI 0.71-0.97),log-rank =0.01),但 BP-EES 组和 DP-EES 组在心脏死亡和临床指导的 TLR 发生率方面没有差异。BP-EES 组 3 年累积的明确 ST 发生率明显低于 DP-EES 组(0%比 1.6%,log-rank =0.02)。
在 3 年内,BP-EES 和 DP-EES 的 TLF 无显著差异。在这项研究中,BP-EES 在中期似乎可以预防明确的 ST,并且比 DP-EES 更安全。