Bo Xu1, Yuichi Saito2, Andreas Baumbach3, Henning Kelbæk4, Niels van Royen5, Ming Zheng6, Marie-Angèle Morel7, Paul Knaapen5, Ton Slagboom8, Thomas W Johnson9, Georgios Vlachojannis10, Karin E Arkenbout11, Lene Holmvang12, Luc Janssens13, Andrzej Ochala14, Salvatore Brugaletta15, Christoph K Naber16, Richard Anderson17, Harald Rittger18, Sergio Berti19, Emanuele Barbato20, Gabor G Toth21, Luc Maillard22, Christian Valina23, Paweł Buszman24, Holge Thiele25, Volker Schächinger26, Alexandra Lansky27, William Wijns28. 1. Fu Wai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China. 2. Yale University School of Medicine, New Haven, Connecticut. 3. Yale University School of Medicine, New Haven, Connecticut; Barts Heart Centre, London and Queen Mary University of London, London, United Kingdom. 4. Department of Cardiology, Roskilde 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. Cardialysis, Rotterdam, the Netherlands. 8. Amsterdam Department of Interventional Cardiolody, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands. 9. Bristol Heart Institute, University Hospitals Bristol NHS Foundation Trust, Bristol, United Kingdom. 10. Division Heart and Lungs, University Medical Center Utrecht, Utrecht, the Netherlands. 11. Department of Cardiology, Tergooi Ziekenhuis, Blaricum, the Netherlands. 12. Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. 13. Heart Centre, Imelda Ziekenhuis, Bonheiden, Belgium. 14. Department of Invasive Cardiology, Silesian Medical University, Katowice, Poland. 15. Cardiovascular Institute, Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain. 16. Contilia Heart and Vascular Centre, Elisabeth-Krankenhaus, Essen, Germany. 17. Department of Cardiology, University Hospital of Wales, Heath Park, Cardiff, United Kingdom. 18. Medizinische Klinik I, Klinikum Fürth, University of Erlangen, Fürth, Germany. 19. UOC Cardiologia Diagnostica ed Interventistica, Fondazione C.N.R. Reg. Toscana G. Monasterio, Ospedale del Cuore, Massa, Italy. 20. Cardiovascular Research Centre Aalst, OLV Hospital, Aalst, Belgium; Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy. 21. Department of Cardiology, Medical University of Graz, Graz, Austria. 22. Service de Cardiologie, Clinique Axium, Aix-en-Provence, France. 23. Klinik für Kardiologie und Angiologie II, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany. 24. American Heart of Poland, Katowice, Poland. 25. Herzzentrum Leipzig, Leipzig, Germany. 26. Medizinische Klinik I, Herz-Thorax Zentrum, Klinikum Fulda, Fulda, Germany. 27. Yale University School of Medicine, New Haven, Connecticut; Barts Heart Centre, London and Queen Mary University of London, London, United Kingdom. Electronic address: alexandra.lansky@yale.edu. 28. The Lambe Institute for Translational Medicine and Curam, National University of Ireland, Galway, and Saolta University Healthcare Group, University College Hospital Galway, Galway, Ireland.
Abstract
OBJECTIVES: The aim of this study was to assess the 2-year clinical outcomes of the Firehawk stent (Shanghai MicroPort Medical Group, Shanghai, China), a novel abluminal groove-filled biodegradable-polymer sirolimus-eluting coronary stent, compared with XIENCE (Abbott Vascular, Santa Clara, California), a durable-polymer everolimus-eluting coronary stent. BACKGROUND: The long-term outcomes of the Firehawk stent have not been evaluated beyond 1 year in a randomized all-comers clinical trial. METHODS: The TARGET All Comers study is a prospective, multicenter, all-comers, randomized, noninferiority trial conducted in Europe. A total of 1,653 patients were randomly assigned to undergo implantation of either the Firehawk or the XIENCE stent. The primary endpoint was target lesion failure, a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization. RESULTS: At 2-year follow-up, the incidence of target lesion failure was 8.7% in the Firehawk group versus 8.6% in the XIENCE group (p = 0.92). The event rates of individual components of the primary endpoint were comparable for the 2 groups. Landmark analyses between 1- and 2-year follow-up revealed no statistically significant difference of TLF for the Firehawk versus the XIENCE stent. Beyond 1 year, very late definite or probable stent thrombosis occurred in 3 patients (0.4%) in the Firehawk group and in 7 patients (0.9%) in the XIENCE group (p = 0.34). CONCLUSIONS: The 2-year follow-up of the TARGET All Comers study confirms comparable safety and efficacy profiles of the Firehawk and XIENCE stents.
RCT Entities:
OBJECTIVES: The aim of this study was to assess the 2-year clinical outcomes of the Firehawk stent (Shanghai MicroPort Medical Group, Shanghai, China), a novel abluminal groove-filled biodegradable-polymer sirolimus-eluting coronary stent, compared with XIENCE (Abbott Vascular, Santa Clara, California), a durable-polymer everolimus-eluting coronary stent. BACKGROUND: The long-term outcomes of the Firehawk stent have not been evaluated beyond 1 year in a randomized all-comers clinical trial. METHODS: The TARGET All Comers study is a prospective, multicenter, all-comers, randomized, noninferiority trial conducted in Europe. A total of 1,653 patients were randomly assigned to undergo implantation of either the Firehawk or the XIENCE stent. The primary endpoint was target lesion failure, a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization. RESULTS: At 2-year follow-up, the incidence of target lesion failure was 8.7% in the Firehawk group versus 8.6% in the XIENCE group (p = 0.92). The event rates of individual components of the primary endpoint were comparable for the 2 groups. Landmark analyses between 1- and 2-year follow-up revealed no statistically significant difference of TLF for the Firehawk versus the XIENCE stent. Beyond 1 year, very late definite or probable stent thrombosis occurred in 3 patients (0.4%) in the Firehawk group and in 7 patients (0.9%) in the XIENCE group (p = 0.34). CONCLUSIONS: The 2-year follow-up of the TARGET All Comers study confirms comparable safety and efficacy profiles of the Firehawk and XIENCE stents.