Corrado Tamburino1, Sabine Bleiziffer2, Holger Thiele3, Smita Scholtz4, David Hildick-Smith5, Michael Cunnington6, Alexander Wolf7, Marco Barbanti8, Didier Tchetchè9, Philippe Garot10, Paolo Pagnotta11, Martine Gilard12, Francesco Bedogni13, Eric Van Belle14, Mariuca Vasa-Nicotera15, Alaide Chieffo16, Oliver Deutsch17, Jörg Kempfert18, Lars Søndergaard19, Christian Butter20, Ramiro Trillo-Nouche21, Shahram Lotfi22, Helge Möllmann23, Michael Joner24, Mohamed Abdel-Wahab3, Kris Bogaerts25,26, Christian Hengstenberg27, Davide Capodanno1. 1. Department of General Surgery and Medical-Surgical Subspecialties, University of Catania, Italy (C.T., D.C.). 2. Department of Cardiothoracic Surgery (S.B.), Heart and Diabetes Center Northrhein-Westfalia, Bad Oeynhausen, Germany. 3. Department of Cardiology, Heart Center Leipzig at University Leipzig, Germany (H.T., M.A.-W.). 4. Department of Interventional Cardiology (S.S.), Heart and Diabetes Center Northrhein-Westfalia, Bad Oeynhausen, Germany. 5. Department of Cardiology, Brighton and Sussex University Hospitals National Health Service Trust, Brighton, United Kingdom (D.H.-S.). 6. Department of Cardiology, Leeds General Infirmary, Leeds Teaching Hospitals National Health Service Trust, United Kingdom (M.C.). 7. Department of Cardiology, Elisabeth Hospital Essen, Germany (A.W.). 8. Department of Cardio-Thoracic-Vascular Diseases and Transplantations, Azienda Ospedaliero-Universitaria Policlinico "G. Rodolico-San Marco," Catania, Italy (M.B.). 9. Groupe CardioVasculaire Interventionnel, Clinique Pasteur, Toulouse, France (D.T.). 10. Hôpital Privé Jacques Cartier, Institut Cardio-vasculaire Paris-Sud, Ramsay-Santé, Massy, France (P.G.). 11. Department of Cardiovascular Medicine, Humanitas Clinical and Research Center, Milano, Italy (P.P.). 12. Department of Cardiology, Brest University Hospital, France (M.G.). 13. Cardiology Department, Istituti di Ricovero e Cura a Carattere Scientifico Policlinico San Donato, Milano, Italy (F.B.). 14. Department of Cardiology, University Hospital, Lille, France (E.V.B.). 15. Department of Cardiology, Goethe University Hospital Frankfurt, Frankfurt am Main, Germany (M.V.-N.). 16. Interventional Cardiology Unit, Istituti di Ricovero e Cura a Carattere Scientifico San Raffaele Scientific Institute, Milan, Italy (A.C.). 17. Department of Cardiovascular Surgery, German Heart Centre Munich, Germany (O.D.). 18. Deutsches Herzzentrum Berlin, Charité Universitätsmedizin, Berlin, Germany (J.K.). 19. The Heart Center-Rigshospitalet, Copenhagen, Denmark (L.S.). 20. Department of Cardiology, Heart Center Brandenburg in Bernau and Brandenburg Medical School, Germany (C.B.). 21. Servicio de Cardiología, Complejo Hospitalario Universitario de Santiago de Compostela, Spain (R.T.-N.). 22. Department of Cardiovascular Surgery, University Hospital RWTH Aachen, Germany (S.L.). 23. Department of Cardiology, St Johannes Hospital, Dortmund, Germany (H.M.). 24. Klinik für Herz und Kreislauferkrankungen, Deutsches Herzzentrum München, Munich, Germany (M.J.). 25. Department of Public Health and Primary Care, I-BioStat, KU Leuven, Belgium (K.B.). 26. I-BioStat, Universiteit Hasselt, Belgium (K.B.). 27. Department of Internal Medicine II, Medical University of Vienna, Austria (C.H.).
Abstract
BACKGROUND: Few randomized trials have compared bioprostheses for transcatheter aortic valve replacement, and no trials have compared bioprostheses with supra-annular design. The SCOPE 2 trial (Safety and Efficacy Comparison of Two TAVI Systems in a Prospective Randomized Evaluation 2) was designed to compare the clinical outcomes of the ACURATE neo and CoreValve Evolut bioprostheses for transcatheter aortic valve replacement. METHODS: SCOPE 2 was a randomized trial performed at 23 centers in 6 countries between April 2017 and April 2019. Patients ≥75 years old with an indication for transfemoral transcatheter aortic valve replacement as agreed by the heart team were randomly assigned to receive treatment with either the ACURATE neo (n=398) or the CoreValve Evolut bioprostheses (n=398). The primary end point, powered for noninferiority of the ACURATE neo bioprosthesis, was all-cause death or stroke at 1 year. The key secondary end point, powered for superiority of the ACURATE neo bioprosthesis, was new permanent pacemaker implantation at 30 days. RESULTS: Among 796 randomized patients (mean age, 83.2±4.3 years; mean Society of Thoracic Surgeons Predicted Risk of Mortality score, 4.6±2.9%), clinical follow-up information was available for 778 (98%) patients. Within 1 year, the primary end point occurred in 15.8% of patients in the ACURATE neo group and in 13.9% of patients in the CoreValve Evolut group (absolute risk difference, 1.8%, upper 1-sided 95% confidence limit, 6.1%; P=0.0549 for noninferiority). The 30-day rates of new permanent pacemaker implantation were 10.5% in the ACURATE neo group and 18.0% in the CoreValve Evolut group (absolute risk difference, -7.5% [95% CI, -12.4 to -2.60]; P=0.0027). No significant differences were observed in the components of the primary end point. Cardiac death at 30 days (2.8% versus 0.8%; P=0.03) and 1 year (8.4% versus 3.9%; P=0.01), and moderate or severe aortic regurgitation at 30 days (10% versus 3%; P=0.002) were significantly increased in the ACURATE neo group. CONCLUSIONS: Transfemoral transcatheter aortic valve replacement with the self-expanding ACURATE neo did not meet noninferiority compared with the self-expanding CoreValve Evolut in terms of all-cause death or stroke at 1 year, and it was associated with a lower incidence of new permanent pacemaker implantation. In secondary analyses, the ACURATE neo was associated with more moderate or severe aortic regurgitation at 30 days and cardiac death at 30 days and 1 year. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03192813.
BACKGROUND: Few randomized trials have compared bioprostheses for transcatheter aortic valve replacement, and no trials have compared bioprostheses with supra-annular design. The SCOPE 2 trial (Safety and Efficacy Comparison of Two TAVI Systems in a Prospective Randomized Evaluation 2) was designed to compare the clinical outcomes of the ACURATE neo and CoreValve Evolut bioprostheses for transcatheter aortic valve replacement. METHODS: SCOPE 2 was a randomized trial performed at 23 centers in 6 countries between April 2017 and April 2019. Patients ≥75 years old with an indication for transfemoral transcatheter aortic valve replacement as agreed by the heart team were randomly assigned to receive treatment with either the ACURATE neo (n=398) or the CoreValve Evolut bioprostheses (n=398). The primary end point, powered for noninferiority of the ACURATE neo bioprosthesis, was all-cause death or stroke at 1 year. The key secondary end point, powered for superiority of the ACURATE neo bioprosthesis, was new permanent pacemaker implantation at 30 days. RESULTS: Among 796 randomized patients (mean age, 83.2±4.3 years; mean Society of Thoracic Surgeons Predicted Risk of Mortality score, 4.6±2.9%), clinical follow-up information was available for 778 (98%) patients. Within 1 year, the primary end point occurred in 15.8% of patients in the ACURATE neo group and in 13.9% of patients in the CoreValve Evolut group (absolute risk difference, 1.8%, upper 1-sided 95% confidence limit, 6.1%; P=0.0549 for noninferiority). The 30-day rates of new permanent pacemaker implantation were 10.5% in the ACURATE neo group and 18.0% in the CoreValve Evolut group (absolute risk difference, -7.5% [95% CI, -12.4 to -2.60]; P=0.0027). No significant differences were observed in the components of the primary end point. Cardiac death at 30 days (2.8% versus 0.8%; P=0.03) and 1 year (8.4% versus 3.9%; P=0.01), and moderate or severe aortic regurgitation at 30 days (10% versus 3%; P=0.002) were significantly increased in the ACURATE neo group. CONCLUSIONS: Transfemoral transcatheter aortic valve replacement with the self-expanding ACURATE neo did not meet noninferiority compared with the self-expanding CoreValve Evolut in terms of all-cause death or stroke at 1 year, and it was associated with a lower incidence of new permanent pacemaker implantation. In secondary analyses, the ACURATE neo was associated with more moderate or severe aortic regurgitation at 30 days and cardiac death at 30 days and 1 year. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03192813.
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