Alexandra  J. Lansky; Bo Xu; Andreas Baumbach; Henning Kelbæk; Niels van Royen; Ming Zheng; Paul Knaapen; Ton Slagboom; Thomas Johnson; Georgios  J. Vlachojannis; Karin  E. Arkenbout; Lene Holmvang; Luc Janssens; Salvatore Brugaletta; Christoph  K. Naber; Thomas Schmitz; Richard Anderson; Harald Rittger; Sergio Berti; Emanuele Barbato; Gabor  G. Toth; Luc Maillard; Christian  M. Valina; Paweł  E. Buszman; Holger Thiele; Volker Schächinger; William Wijns

doi:10.4244/EIJ-D-23-00409

The Official Journal of EuroPCR and the European Association of Percutaneous Cardiovascular Interventions (EAPCI)

The reference multimedia journal in interventional cardiology

Clinical research

DOI: 10.4244/EIJ-D-23-00409

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

Alexandra J. Lansky¹, MD; Bo Xu², MBBS; Andreas Baumbach³, MD; Henning Kelbæk⁴, MD; Niels van Royen⁵, MD; Ming Zheng⁶, MD; Paul Knaapen⁵, MD; Ton Slagboom⁷, MD; Thomas W Johnson⁸, MD; Georgios J. Vlachojannis⁹, MD, PhD; Karin E. Arkenbout¹⁰, MD; Lene Holmvang¹¹, MD; Luc Janssens¹², MD; Salvatore Brugaletta¹³, MD; Christoph K. Naber¹⁴, MD, PhD; Thomas Schmitz¹⁴, MD; Richard Anderson¹⁵, MD; Harald Rittger¹⁶, MD; Sergio Berti¹⁷, MD; Emanuele Barbato¹⁸, MD; Gabor G. Toth¹⁹, MD; Luc Maillard²⁰, MD; Christian M. Valina²¹, MD; Paweł E. Buszman²²^,²³, MD, PhD; Holger Thiele²⁴, MD; Volker Schächinger²⁵, MD; William Wijns²⁶, MD, DPhil

1. Yale Cardiovascular Research Group, Yale School of Medicine, New Haven, CT, USA; 2. Fuwai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; 3. Barts Heart Centre and Queen Mary University of London, London, United Kingdom; 4. Department of Cardiology, Zealand University Hospital, Roskilde, Denmark; 5. Department of Cardiology, VU University Medical Centre, Amsterdam, the Netherlands; 6. Shanghai MicroPort Medical (Group) Co., Ltd. Shanghai, China; 7. Department of Interventional Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands; 8. Bristol Heart Institute, University of Bristol, and University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, United Kingdom; 9. Department of Cardiology, Maasstad Ziekenhuis, Rotterdam, the Netherlands; 10. Department of Cardiology, Tergooi MC, Blaricum, the Netherlands; 11. Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; 12. Heart Centre, Imeldaziekenhuis, Bonheiden, Belgium; 13. Cardiovascular Institute, Hospital Clínic de Barcelona, and Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain; 14. Contilia Heart and Vascular Center, Elisabeth Krankenhaus Essen, Essen, Germany; 15. Cardiology Department, University Hospital of Wales, Cardiff, United Kingdom; 16. Medizinische Klinik I, Klinikum Fürth, Fürth, Germany; 17. UOC Cardiologia Diagnostica e Interventistica, Ospedale del Cuore, Fondazione C.N.R. Regione Toscana G. Monasterio, Massa, Italy; 18. Department of Clinical and Molecular Medicine, Faculty of Medicine and Psychology, Sapienza University of Rome, Rome, Italy; 19. Department of Cardiology, Medical University of Graz, Graz, Austria; 20. Service de Cardiologie, Clinique Axium, Aix-en-Provence, France; 21. Klinik für Kardiologie und Angiologie II, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany; 22. American Heart of Poland, Katowice, Poland; 23. Department of Epidemiology and Biostatistics, Medical School of Silesia, Katowice, Poland; 24. Heart Center Leipzig at University of Leipzig, Leipzig, Germany; 25. Medizinische Klinik I, Herz-Thorax Zentrum, Klinikum Fulda, Fulda, Germany; 26. The Lambe Institute for Translational Medicine and CURAM, University of Galway, and Saolta University Health Care Group, University Hospital Galway, Galway, Ireland

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.

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