Author + information
- Received April 3, 2019
- Revision received May 1, 2019
- Accepted May 1, 2019
- Published online September 2, 2019.
- Bo Xu, MDa,
- Yuichi Saito, MDb,
- Andreas Baumbach, MDb,c,
- Henning Kelbæk, MDd,
- Niels van Royen, MDe,
- Ming Zheng, MDf,
- Marie-Angèle Morel, BScg,
- Paul Knaapen, MDe,
- Ton Slagboom, MDh,
- Thomas W. Johnson, MDi,
- Georgios Vlachojannis, MDj,
- Karin E. Arkenbout, MDk,
- Lene Holmvang, MDl,
- Luc Janssens, MDm,
- Andrzej Ochala, MDn,
- Salvatore Brugaletta, MDo,
- Christoph K. Naber, MDp,
- Richard Anderson, MDq,
- Harald Rittger, MDr,
- Sergio Berti, MDs,
- Emanuele Barbato, MDt,u,
- Gabor G. Toth, MDv,
- Luc Maillard, MDw,
- Christian Valina, MDx,
- Paweł Buszman, MDy,
- Holge Thiele, MDz,
- Volker Schächinger, MDaa,
- Alexandra Lansky, MDb,c,∗ (, )
- William Wijns, MDbb,
- on behalf of the TARGET AC Investigators
- aFu Wai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China
- bYale University School of Medicine, New Haven, Connecticut
- cBarts Heart Centre, London and Queen Mary University of London, London, United Kingdom
- dDepartment of Cardiology, Roskilde University Hospital, Roskilde, Denmark
- eDepartment of Cardiology, VU University Medical Centre, Amsterdam, the Netherlands
- fShanghai MicroPort Medical (Group) Co., Ltd., Shanghai, China
- gCardialysis, Rotterdam, the Netherlands
- hAmsterdam Department of Interventional Cardiolody, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands
- iBristol Heart Institute, University Hospitals Bristol NHS Foundation Trust, Bristol, United Kingdom
- jDivision Heart and Lungs, University Medical Center Utrecht, Utrecht, the Netherlands
- kDepartment of Cardiology, Tergooi Ziekenhuis, Blaricum, the Netherlands
- lDepartment of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
- mHeart Centre, Imelda Ziekenhuis, Bonheiden, Belgium
- nDepartment of Invasive Cardiology, Silesian Medical University, Katowice, Poland
- oCardiovascular Institute, Hospital Clinic, Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain
- pContilia Heart and Vascular Centre, Elisabeth-Krankenhaus, Essen, Germany
- qDepartment of Cardiology, University Hospital of Wales, Heath Park, Cardiff, United Kingdom
- rMedizinische Klinik I, Klinikum Fürth, University of Erlangen, Fürth, Germany
- sUOC Cardiologia Diagnostica ed Interventistica, Fondazione C.N.R. Reg. Toscana G. Monasterio, Ospedale del Cuore, Massa, Italy
- tCardiovascular Research Centre Aalst, OLV Hospital, Aalst, Belgium
- uDepartment of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy
- vDepartment of Cardiology, Medical University of Graz, Graz, Austria
- wService de Cardiologie, Clinique Axium, Aix-en-Provence, France
- xKlinik für Kardiologie und Angiologie II, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany
- yAmerican Heart of Poland, Katowice, Poland
- zHerzzentrum Leipzig, Leipzig, Germany
- aaMedizinische Klinik I, Herz-Thorax Zentrum, Klinikum Fulda, Fulda, Germany
- bbThe Lambe Institute for Translational Medicine and Curam, National University of Ireland, Galway, and Saolta University Healthcare Group, University College Hospital Galway, Galway, Ireland
- ↵∗Address for correspondence:
Dr. Alexandra Lansky, Yale University School of Medicine, 135 College Street, Suite 101, New Haven, Connecticut 06510.
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.
This research was funded by Shanghai Microport Medical. Dr. Baumbach has received speaking fees from Microport. Dr. Zheng is an employee of Microport. Dr. van Royen has received an honorarium from Microport. Dr. Naber has received speaker fees from Microport. Dr. Lansky has received a research grant and speaker fees from Microport. Dr. Wijns has received a research grant and speaker fees from Microport. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received April 3, 2019.
- Revision received May 1, 2019.
- Accepted May 1, 2019.
- 2019 American College of Cardiology Foundation
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