Robbert J. de Winter1, MD, PhD; Azfar Zaman2, MD; Hironori Hara1,3, MD; Chao Gao3,4, MD; Masafumi Ono1,3, MD; Scot Garg5, MD, PhD; Pieter C. Smits6, MD, PhD; Pim A.L. Tonino7, MD, PhD; Sjoerd H. Hofma8, MD, PhD; Raul Moreno9, MD, PhD; Anirban Choudhury10, MD; Ivo Petrov11, MD; Angel Cequier12, MD; Antonio Colombo13,14, MD; Upendra Kaul15, MD, PhD; Yoshinobu Onuma3, MD, PhD; Patrick W. Serruys3,16, MD, PhD
1. Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands; 2. Newcastle Freeman Hospital, Newcastle University, and Newcastle upon Tyne Hospitals NHS Trust, Newcastle, United Kingdom; 3. Department of Cardiology, National University of Ireland Galway, Galway, Ireland; 4. Department of Cardiology, Radboud University, Nijmegen, the Netherlands; 5. Department of Cardiology, Royal Blackburn Hospital, Blackburn, United Kingdom; 6. Maasstad Ziekenhuis, Rotterdam, the Netherlands; 7. Department of Cardiology, Catharina Hospital, Eindhoven, the Netherlands; 8. Medical Centre Leeuwarden, Leeuwarden, the Netherlands; 9. Cardiology Department, La Paz University Hospital, Madrid, Spain; 10. Department of Cardiology, University Hospital of Wales, Cardiff, United Kingdom; 11. Acibadem City Clinic Cardiovascular Center, Sofia, Bulgaria; 12. Bellvitge University Hospital, University of Barcelona, IDIBELL, Barcelona, Spain; 13. Invasive Cardiology Unit, Humanitas Clinical and Research Center, IRCCS, Rozzano, Milan, Italy; 14. Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy; 15. Academics and Research, Batra Hospital and Medical Research Center, New Delhi, India; 16. NHLI, Imperial College London, London, United Kingdom
Background: In the TALENT study, the sirolimus-eluting ultrathin strut Supraflex stent was non-inferior to the XIENCE stent for a device-oriented composite endpoint (DoCE: defined as cardiac death, target-vessel myocardial infarction [TV-MI], or clinically indicated target lesion revascularisation [CI-TLR]) at 12 months.
Aims: This study investigated the 3-year outcomes of the TALENT trial and long-term impact of ultrathin drug-eluting stents (DES), compared to the XIENCE everolimus-eluting thin stent.
Methods: The TALENT trial is a prospective, multicentre, randomised all-comers trial comparing the Supraflex sirolimus-eluting stent with the XIENCE everolimus-eluting stent, with planned follow-up for 3 years.
Results: The TALENT trial enrolled 1,435 patients (Supraflex n=720, XIENCE n=715) with 3-year follow-up data available in 97.8% in the Supraflex group, and in 98.9% in the XIENCE group. At 3 years, DoCE occurred in 57 patients (8.1%) in the Supraflex group, and in 66 patients (9.4%) in the XIENCE group (p=0.406). There were no significant between-group differences in rates of cardiac death, TV-MI or CI-TLR. The rates of definite or probable stent thrombosis were low and similar between groups (1.1% vs 1.4%; p=0.640). In a meta-analysis of long-term follow-up (3-5 years), ultrathin strut DES tended to reduce DoCE (relative risk 0.89 [0.79-1.01]; p=0.068), compared to thicker strut DES. The risks for cardiac death and definite or probable stent thrombosis were similar between ultrathin strut DES and thicker strut DES.
Conclusions: At 3-year follow-up, the use of the Supraflex stent was at least as safe and efficacious as the XIENCE stent in an all-comers population. ClinicalTrials.gov: NCT02870140
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