Azfar Zaman1, Robbert J de Winter2, Norihiro Kogame3, Chun Chin Chang4, Rodrigo Modolo5, Ernest Spitzer6, Pim Tonino7, Sjoerd Hofma8, Aleksander Zurakowski9, Pieter C Smits10, Janusz Prokopczuk11, Raul Moreno12, Anirban Choudhury13, Ivo Petrov14, Angel Cequier15, Neville Kukreja16, Angela Hoye17, Andrés Iniguez18, Imre Ungi19, Antonio Serra20, Robert J Gil21, Simon Walsh22, Gincho Tonev23, Anthony Mathur24, Bela Merkely25, Antonio Colombo26, Sander Ijsselmuiden27, Osama Soliman6, Upendra Kaul28, Yoshinobu Onuma29, Patrick W Serruys30. 1. Freeman Hospital, Newcastle University, and Newcastle upon Tyne Hospitals NHS Trust, Newcastle, UK. 2. Department of Cardiology, Amsterdam University Medical Center, Amsterdam, Netherlands. 3. Department of Cardiology, Amsterdam University Medical Center, Amsterdam, Netherlands; Department of Cardiology, Toho University Medical Centre Ohashi Hospital, Tokyo, Japan. 4. Thoraxcenter, Erasmus University Medical Centre, Rotterdam, Netherlands; Cardiology Division, Department of Internal Medicine, Taipei Veterans General Hospital, Taiwan. 5. Department of Cardiology, Amsterdam University Medical Center, Amsterdam, Netherlands; Cardiology Division, Department of Internal Medicine, University of Campinas, Campinas, SP, Brazil. 6. Thoraxcenter, Erasmus University Medical Centre, Rotterdam, Netherlands; Cardialysis Clinical Trials Management and Core Laboratories, Rotterdam, Netherlands. 7. Department of Cardiology, Catharina Hospital, Eindhoven, Netherlands. 8. Medical Centre Leeuwarden, Leeuwarden, Netherlands. 9. Małopolskie Centrum Sercowo-Naczyniowe PAKS, Chrzanow, Poland. 10. Maasstad Ziekenhuis, Rotterdam, Netherlands. 11. PAKS Kędzierzyn, Koźle, Poland. 12. Cardiology Department, La Paz University Hospital, Madrid, Spain. 13. Department of Cardiology, University Hospital of Wales, Cardiff, UK. 14. Acibadem City Clinic Cardiovascular Center, Sofia, Bulgaria. 15. University Hospital of Bellvitge, Barcelona, Spain. 16. Department of Cardiology, East and North Hertfordshire NHS Trust, Hertfordshire, UK. 17. Department of Academic Cardiology, University of Hull, Castle Hill Hospital, UK. 18. Hospital do Meixoeiro, Vigo, Spain. 19. Division of Invasive Cardiology, Second Department of Internal Medicine and Cardiology Center, University of Szeged, Szeged, Hungary. 20. Unidad de Cardiología Intervencionista, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain. 21. Department of Invasive Cardiology, Central Clinical Hospital of the Ministry of Interior, Warsaw, Poland; Mossakowski Medical Research Centre, Polish Academy of Science, Warsaw, Poland. 22. Department of Cardiology Belfast Health & Social Care Trust, Belfast, UK. 23. Multi-profile Hospital for Active Treatment, St George's University, Plovdiv, Bulgaria. 24. Department of Cardiology, Barts Heart Centre, Barts Health NHS Trust, London, UK. 25. Heart and Vascular Center, Semmelweis University, Budapest, Hungary. 26. Division of Interventional Cardiology, Cardio-Thoracic-Vascular Department, San Raffaele Scientific Institute, Milan, Italy. 27. Amphia Ziekenhuis, Breda, Netherlands. 28. Academics and Research, Batra Hospital and Medical Research Center, New Delhi, India. 29. Thoraxcenter, Erasmus University Medical Centre, Rotterdam, Netherlands; Cardialysis Clinical Trials Management and Core Laboratories, Rotterdam, Netherlands. Electronic address: yonuma@cardialysis.nl. 30. International Centre for Circulatory Health, Imperial College London, London, UK. Electronic address: patrick.w.j.c.serruys@pwserruys.com.
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<0·0001). Definite or probable stent thrombosis prevalence, a safety indicator, was low in both groups and did not differ between them. INTERPRETATION: The Supraflex stent was non-inferior to the Xience stent for a device-oriented composite clinical endpoint at 12 months in an all-comer population. Supraflex seems a safe and effective alternative drug-eluting stent to other stents in clinical practice. FUNDING: European Cardiovascular Research Institute.
RCT Entities:
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<0·0001). Definite or probable stent thrombosis prevalence, a safety indicator, was low in both groups and did not differ between them. INTERPRETATION: The Supraflex stent was non-inferior to the Xience stent for a device-oriented composite clinical endpoint at 12 months in an all-comer population. Supraflex seems a safe and effective alternative drug-eluting stent to other stents in clinical practice. FUNDING: European Cardiovascular Research Institute.
Authors: Mahesh V Madhavan; James P Howard; Azim Naqvi; Ori Ben-Yehuda; Bjorn Redfors; Megha Prasad; Bahira Shahim; Martin B Leon; Sripal Bangalore; Gregg W Stone; Yousif Ahmad Journal: Eur Heart J Date: 2021-07-15 Impact factor: 29.983