TY - JOUR
T1 - 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
AU - Lansky, Alexandra J
AU - Xu, Bo
AU - Baumbach, Andreas
AU - Kelbæk, Henning
AU - van Royen, Niels
AU - Zheng, Ming
AU - Knaapen, Paul
AU - Slagboom, Ton
AU - Johnson, Thomas W
AU - Vlachojannis, Georgios J
AU - Arkenbout, Karin E
AU - Holmvang, Lene
AU - Janssens, Luc
AU - Brugaletta, Salvatore
AU - Naber, Christoph K
AU - Schmitz, Thomas
AU - Anderson, Richard
AU - Rittger, Harald
AU - Berti, Sergio
AU - Barbato, Emanuele
AU - Toth, Gabor G
AU - Maillard, Luc
AU - Valina, Christian M
AU - Buszman, Paweł E
AU - Thiele, Holger
AU - Schächinger, Volker
AU - Wijns, William
PY - 2023/12/4
Y1 - 2023/12/4
N2 - 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.
AB - 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.
KW - Absorbable Implants
KW - Drug-Eluting Stents/adverse effects
KW - Everolimus
KW - Humans
KW - Myocardial Infarction/etiology
KW - Percutaneous Coronary Intervention/adverse effects
KW - Polymers
KW - Prospective Studies
KW - Sirolimus
KW - Treatment Outcome
UR - https://eurointervention.pcronline.com/article/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
UR - https://www.scopus.com/pages/publications/85178666250
U2 - 10.4244/EIJ-D-23-00409
DO - 10.4244/EIJ-D-23-00409
M3 - Journal article
C2 - 37860860
SN - 1774-024X
VL - 19
SP - e844-e855
JO - EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
JF - EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
IS - 10
ER -