Imperial College London, London, United Kingdom.
EuroIntervention. 2019 Jun 12;15(3):e244-e252. doi: 10.4244/EIJ-D-18-00980.
The purpose of the study was to investigate whether the favourable outcomes of state-of-the-art PCI in the SYNTAX II trial, demonstrated at one year, were maintained at two-year follow-up.
The SYNTAX II study was a multicentre, single-arm study that investigated the impact of a contemporary PCI strategy on clinical outcomes in 454 patients with de novo three-vessel coronary artery disease, without left main disease. Clinical outcomes in SYNTAX II were compared to the predefined PCI (SYNTAX-I PCI) and coronary artery bypass graft (SYNTAX-I CABG) cohorts from the landmark SYNTAX trial (SYNTAX-I), selected on the basis of equipoise for long-term (four-year) mortality utilising the SYNTAX score II. At two years, major adverse cardiac and cerebrovascular events (MACCE: a composite of all-cause death, any stroke, myocardial infarction, or revascularisation) in SYNTAX II were significantly lower compared to SYNTAX-I PCI (13.2% vs. 21.9%, p=0.001). Furthermore, similar two-year outcomes for MACCE were evident between SYNTAX II PCI and SYNTAX-I CABG (13.2% vs. 15.1%, p=0.42).
At two years, clinical outcomes with the SYNTAX II strategy remained superior to the predefined SYNTAX-I PCI cohort, and similar to the predefined SYNTAX-I CABG cohort.
本研究旨在探讨在 SYNTAX II 试验中,先进的 PCI 治疗在一年时表现出的良好结果是否在两年随访时得以维持。
SYNTAX II 研究是一项多中心、单臂研究,调查了在 454 例无左主干病变的新发三血管冠状动脉疾病患者中,采用当代 PCI 策略对临床结局的影响。SYNTAX II 研究中的临床结局与预先设定的 PCI(SYNTAX-I PCI)和冠状动脉旁路移植术(SYNTAX-I CABG)队列进行了比较,后者是基于 SYNTAX 评分 II 对长期(四年)死亡率的均衡选择,来自里程碑式的 SYNTAX 试验(SYNTAX-I)。两年时,SYNTAX II 中的主要不良心脑血管事件(MACCE:全因死亡、任何卒中、心肌梗死或血运重建的复合终点)明显低于 SYNTAX-I PCI(13.2%比 21.9%,p=0.001)。此外,SYNTAX II PCI 与 SYNTAX-I CABG 之间的 MACCE 两年结局也相似(13.2%比 15.1%,p=0.42)。
两年时,SYNTAX II 策略的临床结局仍优于预先设定的 SYNTAX-I PCI 队列,且与预先设定的 SYNTAX-I CABG 队列相似。