Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
SHR Neuro Krebs Kardio Lipid Stoffw Microb
Lansky, AJ; Xu, B; Baumbach, A; Kelbaek, H; van Royen, N; Zheng, M; Knaapen, P; Slagboom, T; Johnson, TW; Vlachojannis, GJ; Arkenbout, KE; Holmvang, L; Janssens, L; Brugaletta, S; Naber, CK; Schmitz, T; Anderson, R; Rittger, H; Berti, S; Barbato, E; Toth, GG; Maillard, L; Valina, CM; Buszman, PE; Thiele, H; Schaechinger, V; Wijns, W.
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
EUROINTERVENTION. 2023; 19(10): E844-+.
Doi: 10.4244/EIJ-D-23-00409
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- Co-Autor*innen der Med Uni Graz
- Toth-Gayor Gabor
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- Abstract:
- Background: In the prospective, multicentre, randomised TARGET All Comers study, percutaneous coro-nary 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 (com-posite of cardiac death, target vessel myocardial infarction [MI], or ischaemia-driven target lesion revascu-larisation). 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 dif-ferences 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.
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