The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)
A randomized controlled trial to compare the safety and efficacy of sirolimus-eluting biodegradable polymer ultra-thin stent (SUPRAFLEX Cruz) and everolimus-eluting biodegradable polymer stent (SYNERGY) in treatment for three-vessel coronary artery disease: design of the Multivessel TALENT trial
Hironori Hara1,2; Chao Gao2,3; Norihiro Kogame1; Masafumi Ono1,2; Hideyuki Kawashima1,2; Rutao Wang2,3; Marie-angele Morel2; Neil O'Leary4; Faisal Sharif2; Helge Möllmann5; Johan H. C. Reiber6; Manel Sabaté7; Azfar Zaman8; William Wijns9; Yoshinobu Onuma2; Patrick W Serruys2,10;
1. Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands 2. Department of cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland 3. Department of Cardiology, Radbound University, Nijmegen, The Netherlands 4. Health Research Board Clinical Research Facility, Department of Medicine, NUIG, Galway, Ireland 5. Department of Cardiology, St. Johannes Hospital, Dortmund, Germany 6. Division of Image Processing, Department of Radiology, Leiden University Medical Center, Leiden, The Netherlands 7. Department of Cardiology, Clinic Hospital, Barcelona, Spain 8. Department of Cardiology, Freeman Hospital and Faculty of Medical Sciences, Newcastle University, Newcastle-upon-Tyne, UK 9. Lambe Institute for Translational Research, School of Medicine, NUIG, Galway, Ireland 10.NHLI, Imperial College London, London, UK
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Aims: The purpose of the Multivessel TALENT trial is to compare clinical outcomes of novel SUPRAFLEX Cruz stent with those of SYNERGY stent in patients with three vessel disease (3VD) undergoing state-of-the-art percutaneous coronary intervention (PCI).
Methods and results: In this prospective, randomized, 1:1 balanced, multi-center, open-label trial, 1550 patients with de novo 3VD without left main disease are assigned to the SUPRAFLEX Cruz or SYNERGY arm. The following treatment principles of the “best practice” PCI will be applied: Heart Team consensus based on SYNTAX Score II treatment recommendation, functional lesion evaluation by quantitative flow ratio (QFR), stent optimization by intravascular imaging, optimal pharmacological treatment and prasugrel monotherapy. The primary endpoint is a non-inferiority comparison of patient-oriented composite endpoint (POCE) of all-cause death, any stroke, any myocardial infarction, or any revascularization, at 12 months post-procedure. The powered secondary endpoint is a superiority comparison of vessel-oriented composite endpoint (VOCE) defined as vessel-related cardiovascular death, vessel-related myocardial infarction, or clinically and physiologically-indicated-target vessel revascularization, at 24 months.
Conclusions: The Multivessel TALENT trial will be evaluating a novel treatment strategy for complex coronary artery disease with state-of-the-art PCI based on angiography-derived QFR with novel ultra-thin SUPRAFLEX Cruz stents, compared with the SYNERGY stents.