Department of Cardiovascular Medicine, St. Luke's International Hospital, St. Luke's International University, Tokyo, Japan.
Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
EuroIntervention. 2022 Mar 18;17(16):1318-1329. doi: 10.4244/EIJ-D-21-00192.
With the improvements of percutaneous coronary intervention (PCI) technology and post-PCI patient management, several registry studies reported temporal trends in post-PCI clinical outcomes. However, their results are inconclusive, potentially reflecting region-specific trends, based on site-reported events without external validity.
This study aimed to investigate temporal trends in post-PCI clinical outcomes in all-comers randomised controlled trials (RCTs) involving coronary stents.
We performed a systematic review identifying RCTs comparing a clinical outcome as a primary endpoint among different coronary stents with an all-comers design and independent clinical event adjudication, extracting the study start year, patient baseline characteristics, and one- and five-year clinical outcomes. Temporal trends in clinical outcomes (cardiac death, myocardial infarction [MI], target lesion revascularisation [TLR], stent thrombosis [ST]) were assessed using random-effects meta-regression analyses, estimating the relationship between clinical outcomes and study start year.
Overall, 25 all-comers trials (51 device arms, 66,327 patients) conducted between 2003 and 2018 fulfilled the eligibility criteria. Random-effects meta-regression analysis revealed significant decreasing trends in one- and five-year cardiac death, one-year TLR, and five-year ST incidences (relative risk per 10-year increase: 0.69 [0.51-0.92], 0.66 [0.44-0.98], 0.60 [0.41-0.88], and 0.18 [0.07-0.44], respectively). There was no significant trend in myocardial infarction incidences.
This is the first attempt to clarify and quantify the temporal trends of post-PCI outcome incidence. The 15-year improvements in PCI therapy and post-therapeutic patient management are associated with reduced incidences of cardiac death and PCI-related adverse events.
随着经皮冠状动脉介入治疗(PCI)技术和 PCI 后患者管理的进步,几项注册研究报告了 PCI 后临床结局的时间趋势。然而,他们的结果并不一致,可能反映了基于站点报告事件而没有外部有效性的特定地区的趋势。
本研究旨在调查所有接受者随机对照试验(RCT)中 PCI 后临床结局的时间趋势,这些试验涉及冠状动脉支架。
我们进行了一项系统评价,确定了 RCT,这些 RCT 比较了不同冠状动脉支架的临床结局作为主要终点,这些 RCT 采用了所有接受者设计和独立的临床事件评估,提取了研究开始年份、患者基线特征以及一年和五年的临床结局。使用随机效应荟萃回归分析评估临床结局(心脏死亡、心肌梗死[MI]、靶病变血运重建[TLR]、支架血栓形成[ST])的时间趋势,估计临床结局与研究开始年份之间的关系。
共有 25 项所有接受者试验(51 个器械臂,66327 名患者)于 2003 年至 2018 年期间进行,符合入选标准。随机效应荟萃回归分析显示,一年和五年心脏死亡、一年 TLR 和五年 ST 发生率呈显著下降趋势(每 10 年增加的相对风险:0.69 [0.51-0.92]、0.66 [0.44-0.98]、0.60 [0.41-0.88]和 0.18 [0.07-0.44])。心肌梗死发生率无显著趋势。
这是首次尝试澄清和量化 PCI 后结局发生率的时间趋势。15 年来 PCI 治疗和治疗后患者管理的改善与心脏死亡和 PCI 相关不良事件发生率的降低有关。