Safety and efficacy of a sirolimus-eluting coronary stent with ultra-thin strut for treatment of atherosclerotic lesions (TALENT): a prospective multicentre randomised controlled trial

Zaman, Azfar; de Winter, Robbert J.; Kogame, Norihiro; Chang, Chun Chin; Modolo, Rodrigo; Spitzer, Ernest; Tonino, Pim; Hofma, Sjoerd; Zurakowski, Aleksander; Smits, Pieter C.; Prokopczuk, Janusz; Moreno, Raul; Choudhury, Anirban; Petrov, Ivo; Cequier, Angel; Kukreja, Neville; Hoye, Angela; Iniguez, Andrés; Ungi, Imre; Serra, Antonio; Gil, Robert J.; Walsh, Simon; Tonev, Gincho; Mathur, Anthony; Merkely, Bela; Colombo, Antonio; Ijsselmuiden, Sander; Soliman, Osama; Kaul, Upendra; Onuma, Yoshinobu; Serruys, Patrick W.

Abstract

Background: Supraflex is a sirolimus-eluting stent with a biodegradable polymer coating and ultra-thin struts. We aimed to compare Supraflex with the standard of care, Xience, an everolimus-eluting stent with a durable polymer coating, regarding clinical outcomes with a randomised trial in an all-comer population. Methods: We did a prospective, randomised, single-blind, multicentre study (TALENT) across 23 centres in Europe (the Netherlands, Poland, the UK, Spain, Bulgaria, Hungary, and Italy). Eligible participants were aged 18 years or older, had one or more coronary artery stenosis of 50% or greater in a native coronary artery, saphenous venous graft, or arterial bypass conduit, and had a reference vessel diameter of 2·25–4·50 mm. Patients underwent percutaneous coronary intervention in an all-comer manner. We randomly assigned patients (1:1) to implantation of either a sirolimus-eluting stent with a biodegradable polymer coating and ultra-thin struts (Supraflex) or an everolimus-eluting stent with a durable polymer coating (Xience). Randomisation was done by local investigators by use of a web-based software with random blocks according to centre. The primary endpoint was a non-inferiority comparison of a device-oriented composite endpoint—cardiac death, target-vessel myocardial infarction, or clinically indicated target lesion revascularisation—between groups at 12 months after the procedure, assessed in an intention-to-treat population. On assumption of 1-year composite endpoint prevalence of 8·3%, a margin of 4·0% was defined for non-inferiority of the Supraflex group compared with the Xience group. This trial is registered with ClinicalTrials.gov, number NCT02870140. Findings: Between Oct 21, 2016, and July 3, 2017, 1435 patients with 1046 lesions were randomly assigned to Supraflex, of whom 720 received the index procedure, and 715 patients with 1030 lesions were assigned to Xience, all receiving the index procedure. At 12 months, the primary endpoint had occurred in 35 patients (4·9 %) in the Supraflex group and in 37 patients (5·3%) in the Xience group (absolute difference −0·3% [one-sided 95% upper confidence bound 1·6%], pnon-inferiority

Citation

Zaman, A., de Winter, R. J., Kogame, N., Chang, C. C., Modolo, R., Spitzer, E., Tonino, P., Hofma, S., Zurakowski, A., Smits, P. C., Prokopczuk, J., Moreno, R., Choudhury, A., Petrov, I., Cequier, A., Kukreja, N., Hoye, A., Iniguez, A., Ungi, I., Serra, A., …Serruys, P. W. (2019). Safety and efficacy of a sirolimus-eluting coronary stent with ultra-thin strut for treatment of atherosclerotic lesions (TALENT): a prospective multicentre randomised controlled trial. Lancet, 393(10175), 987-997. https://doi.org/10.1016/S0140-6736%2818%2932467-X

• Journal Article Type: Article
• Acceptance Date: Apr 2, 2018
• Online Publication Date: Feb 28, 2019
• Publication Date: Mar 9, 2019
• Deposit Date: Jan 29, 2021
• Journal: The Lancet
• Print ISSN: 0140-6736
• Publisher: Elsevier
• Peer Reviewed: Peer Reviewed
• Volume: 393
• Issue: 10175
• Pages: 987-997
• DOI: https://doi.org/10.1016/S0140-6736%2818%2932467-X
• Public URL: https://hull-repository.worktribe.com/output/3588031
• Publisher URL: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)32467-X/fulltext
• Related Public URLs: https://www.sciencedirect.com/science/article/abs/pii/S014067361832467X; Acceptance date from Newcastle University repository: https://eprint.ncl.ac.uk/255904