医学
经皮冠状动脉介入治疗
传统PCI
靶病变
临床终点
支架
心肌梗塞
内科学
西罗莫司
依维莫司
狼牙棒
心脏病学
外科
随机对照试验
作者
Alexandra J. Lansky,Bo Xu,Andreas Baumbach,Henning Kelbæk,Niels van Royen,Ming Zheng,Paul Knaapen,Ton Slagboom,Tom Johnson,Georgios J. Vlachojannis,Karin Arkenbout,Lene Holmvang,Luc Janssens,Salvatore Brugaletta,Christoph Naber,Thomas Schmitz,Richard Anderson,Harald Rittger,Sérgio Berti,Emanuele Barbato,Gábor G. Tóth,Luc Maillard,Christian Valina,Paweł Buszman,Holger Thiele,Volker Schächinger,William Wijns
出处
期刊:Eurointervention
[Europa Digital and Publishing]
日期:2023-12-01
卷期号:19 (10): e844-e855
被引量:2
标识
DOI:10.4244/eij-d-23-00409
摘要
In the prospective, multicentre, randomised TARGET All Comers study, percutaneous coronary intervention (PCI) with the FIREHAWK biodegradable-polymer sirolimus-eluting stent (BP-SES) was non-inferior to the durable-polymer everolimus-eluting stent (DP-EES) for the primary endpoint of target lesion failure (TLF) at 12 months.We aimed to report the final study outcomes at 5 years.Patients referred for PCI were randomised to receive either a BP-SES or DP-EES in a 1:1 ratio in 10 European countries. Randomisation was stratified by centre and ST-elevation myocardial infarction (STEMI) presentation, and clinical follow-up extended to 5 years. The primary endpoint was TLF (composite of cardiac death, target vessel myocardial infarction [MI], or ischaemia-driven target lesion revascularisation). Secondary endpoints included patient-oriented composite events (POCE; composite of all-cause death, all MI, or any revascularisation and its components).From December 2015 to October 2016, 1,653 patients were randomly assigned to the BP-SES or DP-EES groups, of which 93.8% completed 5-year clinical follow-up or were deceased. At 5 years, TLF occurred in 17.1% of the BP-SES group and in 16.3% of the DP-EES group (p=0.68). POCE occurred in 34.0% of the BP-SES group and 32.7% of the DP-EES group (p=0.58). Revascularisation was the most common POCE, occurring in 19.3% of patients receiving BP-SES and 19.2% receiving DP-EES, of which less than one-third was ischaemia-driven target lesion-related. In the landmark analysis, there were no differences in the rates of TLF and POCE between groups from 1 to 5 years, and these results were consistent across all subgroups.In an all-comers population requiring stent implantation for myocardial ischaemia, the BP-SES was non-inferior to the DP-EES for the primary endpoint of TLF at 12 months, and results were sustained at 5 years, confirming the long-term safety and efficacy of the FIREHAWK BP-SES.