| dc.identifier.citation | @article{10.4244/EIJ-D-23-00409,
title = {Targeted therapy with a localised abluminal groove, low-dose sirolimus-eluting, biodegradable-polymer coronary stent – five-year results of the TARGET All Comers randomised clinical trial},
author = {Lansky, Alexandra J. and Xu, Bo and Baumbach, Andreas and Kelbæk, Henning and van Royen, Niels and Zheng, Ming and Knaapen, Paul and Slagboom, Ton and Johnson, Thomas W. and Vlachojannis, Georgios J. and Arkenbout, Karin E. and Holmvang, Lene and Janssens, Luc and Brugaletta, Salvatore and Naber, Christoph K. and Schmitz, Thomas and Anderson, Richard and Rittger, Harald and Berti, Sergio and Barbato, Emanuele and Toth, Gabor G. and Maillard, Luc and Valina, Christian M. and Buszman, Paweł E. and Thiele, Holger and Schächinger, Volker and Wijns, William },
year = {2023},
journal = {EuroIntervention},
volume = {19},
number = {10},
pages = {e844-e855},
doi = {10.4244/EIJ-D-23-00409},
url = {https://doi.org/10.4244/EIJ-D-23-00409},
} | |
| dc.description.abstract | BACKGROUND: 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. AIMS: We aimed to report the final study outcomes at 5 years. METHODS: 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). RESULTS: 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. CONCLUSIONS: 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. | en_US |
