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)....

Forgot your password?

No account yet?
Sign up for free!

Create my pcr account

Join us for free and access thousands of articles from EuroIntervention, as well as presentations, videos, cases from PCRonline.com