The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)
Optical coherence tomography substudy of a prospective multicentre randomised post-market trial to assess the safety and effectiveness of the Firehawk cobalt-chromium coronary stent (rapamycin target-eluting) system for the treatment of atherosclerotic lesions: TARGET All Comers
EuroIntervention 2018;14:1121-1128 published online June 2018. DOI: 10.4244/EIJ-D-18-00226
Andreas Baumbach1,2, MD; Alexandra J. Lansky1,2*, MD; Yoshinobu Onuma3, MD; Taku Asano3, MD; Thomas Johnson4, MD; Richard Anderson5, MD; Ferdinand Kiemeneij6, MD, PhD; Ming Zheng7, MD; Niels van Royen8, MD; Ton Slagboom9, MD; Georg Vlachojannis10, MD; Bo Xu11, MD; Patrick W. Serruys3, MD; William Wijns12, MD
1. Barts Heart Centre, University College London and Queen Mary University of London, London, United Kingdom; 2. Yale University School of Medicine, New Haven, CT, USA; 3. Cardialysis, Rotterdam, the Netherlands; 4. University Hospitals Bristol, Bristol, United Kingdom; 5. Cardiff and Vale University Health Board, Heath Park, Cardiff, Wales, United Kingdom; 6. VU University Medical Center, Amsterdam, the Netherlands; 7. MicroPort, Shanghai, China; 8. Radboud University Medical Centre Nijmegen, Nijmegen, the Netherlands; 9. Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands; 10. Maasstad Ziekenhuis, Rotterdam, the Netherlands; 11. Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China; 12. Lambe Institute for Translational Medicine, Curam, and Saolta University Healthcare Group, National University of Ireland Galway, Galway, Ireland
Aims: Durable polymer drug-eluting stents (DP-DES) may contribute to persistent inflammation, delayed endothelial healing and subsequent late DES thrombosis. The aim of this optical coherence tomography (OCT) substudy was to compare healing and neointimal coverage of a novel bioabsorbable polymer sirolimus-eluting stent (Firehawk®) (BP-DES) versus the DP-DES (XIENCE) at 90 days in an all-comers patient population.
Methods and results: The TARGET All Comers study is a prospective multicentre randomised post-market trial of 1,656 patients randomised 1:1 to Firehawk or XIENCE at 21 centres in 10 European countries. The TARGET OCT substudy enrolled 36 consecutive patients with 52 lesions at six centres proficient in OCT. Follow-up OCT was performed at three months or prior to revascularisation when occurring before the three-month window. The substudy was designed for non-inferiority of the primary endpoint of neointimal thickness. At follow-up, the mean neointimal thickness by OCT (52 lesions: Firehawk, n=24; XIENCE, n=28), was not significantly different between groups (Firehawk 75.5 μm vs. XIENCE V 82.3 μm) meeting the primary endpoint of non-inferiority (pnoninferiority<0.001). The percentage of stent strut coverage was high in both groups (strut level: 99.9±0.3% vs. 100±0.1%, p=0.26), and the proportion of malapposed struts (1.0±1.6% vs. 1.2±2.0%, p=0.51) was low in both groups.
Conclusions: Based on OCT, the Firehawk BP-DES has a similar healing response three months after implantation compared to the DP-DES, with near complete strut coverage, moderate neointima formation and minimal strut malapposition.
Join us for free and access thousands of articles from EuroIntervention, as well as presentations, videos, cases from PCRonline.com
clinical researchoptical coherence tomography
Coronary interventionsInterventions for valvular diseaseInterventions for heart failureInterventions for strokeStents and scaffoldsOther coronary interventionsOther valvular and structural interventionsAcute heart failureChronic heart failureCarotid stenting