2-Year Clinical Outcomes of an Abluminal Groove-Filled Biodegradable-Polymer Sirolimus-Eluting Stent Compared With a Durable-Polymer Everolimus-Eluting Stent
Bo Xu, Yuichi Saito, Andreas Baumbach, Henning Kelbæk, Niels van Royen, Ming Zheng, Marie-Angèle Morel, Paul Knaapen, Ton Slagboom, Thomas W Johnson, Georgios Vlachojannis, Karin E Arkenbout, Lene Holmvang, Luc Janssens, Andrzej Ochala, Salvatore Brugaletta, Christoph K Naber, Richard Anderson, Harald Rittger, Sergio Berti, Emanuele Barbato, Gabor G Toth, Luc Maillard, Christian Valina, Paweł Buszman, Holge Thiele, Volker Schächinger, Alexandra Lansky, William Wijns, TARGET AC Investigators, Bo Xu, Yuichi Saito, Andreas Baumbach, Henning Kelbæk, Niels van Royen, Ming Zheng, Marie-Angèle Morel, Paul Knaapen, Ton Slagboom, Thomas W Johnson, Georgios Vlachojannis, Karin E Arkenbout, Lene Holmvang, Luc Janssens, Andrzej Ochala, Salvatore Brugaletta, Christoph K Naber, Richard Anderson, Harald Rittger, Sergio Berti, Emanuele Barbato, Gabor G Toth, Luc Maillard, Christian Valina, Paweł Buszman, Holge Thiele, Volker Schächinger, Alexandra Lansky, William Wijns, TARGET AC Investigators
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.
Trial registration: ClinicalTrials.gov NCT02520180.
Keywords: Firehawk; clinical outcome; drug-eluting stent; everolimus-eluting stent.
Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed