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.
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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