2-Year Clinical Outcomes of an Abluminal Groove-Filled Biodegradable-Polymer Sirolimus-Eluting Stent Compared With a Durable-Polymer Everolimus-Eluting Stent.

Autor: Xu B; Fu Wai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China., Saito Y; Yale University School of Medicine, New Haven, Connecticut., Baumbach A; Yale University School of Medicine, New Haven, Connecticut; Barts Heart Centre, London and Queen Mary University of London, London, United Kingdom., Kelbæk H; Department of Cardiology, Roskilde University Hospital, Roskilde, Denmark., van Royen N; Department of Cardiology, VU University Medical Centre, Amsterdam, the Netherlands., Zheng M; Shanghai MicroPort Medical (Group) Co., Ltd., Shanghai, China., Morel MA; Cardialysis, Rotterdam, the Netherlands., Knaapen P; Department of Cardiology, VU University Medical Centre, Amsterdam, the Netherlands., Slagboom T; Amsterdam Department of Interventional Cardiolody, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands., Johnson TW; Bristol Heart Institute, University Hospitals Bristol NHS Foundation Trust, Bristol, United Kingdom., Vlachojannis G; Division Heart and Lungs, University Medical Center Utrecht, Utrecht, the Netherlands., Arkenbout KE; Department of Cardiology, Tergooi Ziekenhuis, Blaricum, the Netherlands., Holmvang L; Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark., Janssens L; Heart Centre, Imelda Ziekenhuis, Bonheiden, Belgium., Ochala A; Department of Invasive Cardiology, Silesian Medical University, Katowice, Poland., Brugaletta S; Cardiovascular Institute, Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain., Naber CK; Contilia Heart and Vascular Centre, Elisabeth-Krankenhaus, Essen, Germany., Anderson R; Department of Cardiology, University Hospital of Wales, Heath Park, Cardiff, United Kingdom., Rittger H; Medizinische Klinik I, Klinikum Fürth, University of Erlangen, Fürth, Germany., Berti S; UOC Cardiologia Diagnostica ed Interventistica, Fondazione C.N.R. Reg. Toscana G. Monasterio, Ospedale del Cuore, Massa, Italy., Barbato E; Cardiovascular Research Centre Aalst, OLV Hospital, Aalst, Belgium; Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy., Toth GG; Department of Cardiology, Medical University of Graz, Graz, Austria., Maillard L; Service de Cardiologie, Clinique Axium, Aix-en-Provence, France., Valina C; Klinik für Kardiologie und Angiologie II, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany., Buszman P; American Heart of Poland, Katowice, Poland., Thiele H; Herzzentrum Leipzig, Leipzig, Germany., Schächinger V; Medizinische Klinik I, Herz-Thorax Zentrum, Klinikum Fulda, Fulda, Germany., Lansky A; 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., Wijns W; The Lambe Institute for Translational Medicine and Curam, National University of Ireland, Galway, and Saolta University Healthcare Group, University College Hospital Galway, Galway, Ireland.
Jazyk: angličtina
Zdroj: JACC. Cardiovascular interventions [JACC Cardiovasc Interv] 2019 Sep 09; Vol. 12 (17), pp. 1679-1687. Date of Electronic Publication: 2019 May 22.
DOI: 10.1016/j.jcin.2019.05.001
Abstrakt: 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.
(Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE