The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)

Coronary interventions

A prospective multicentre randomised all-comers trial to assess the safety and effectiveness of the thin-strut sirolimus-eluting coronary stent SUPRAFLEX: rationale and design of the Thin Strut Sirolimus-eluting Stent in All Comers Population vs Everolimus-eluting Stent (TALENT) trial

EuroIntervention 2019;15:e362-e369. DOI: 10.4244/EIJ-D-18-00499

1. Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; 2. Department of Internal Medicine, Cardiology Division, University of Campinas (UNICAMP), Campinas, Brazil; 3. Division of Cardiovascular Medicine, Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Hatyai, Songkhla, Thailand; 4. Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands; 5. Dean Academics and Research, Batra Hospital and Medical Research Center, New Delhi, India; 6. Freeman Hospital. Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, United Kingdom; 7. Cardialysis Clinical Trials Management and Core Laboratories, Rotterdam, the Netherlands; 8. Imperial College London, London, United Kingdom, United Kingdom

Aims: The aim of this study is to compare the SUPRAFLEX sirolimus-eluting stent (SES) with the XIENCE everolimus-eluting stent (EES) with respect to target lesion failure (TLF) at 12 months in a non-inferiority trial in a “real-world” patient population.

Methods and results: This is a prospective, randomised, 1:1 balanced, controlled, single-blind, multicentre study comparing clinical outcomes at 12 months between SUPRAFLEX and XIENCE in an “all-comers” patient population, comprising a total of 1,430 enrolled subjects with symptomatic coronary artery disease who qualify for percutaneous coronary interventions at 23 centres in Europe. The primary endpoint is a non-inferiority comparison of the device-oriented composite endpoint target lesion failure (cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularisation) of the SUPRAFLEX group to the XIENCE group at 12 months post procedure. Secondary endpoints include the patient-oriented composite endpoint, target vessel failure, mortality, myocardial infarction, revascularisation and stent thrombosis rates (ARC classification).

Conclusions: The TALENT trial aims to assess the safety and effectiveness of the thin-strut SUPRAFLEX compared to the current standard of care (XIENCE EES) in patients with atherosclerotic lesions. This will provide valuable information on the impact of this thin-strut device in an all-comers population.

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