Holger Thiele1,2, Thomas Kurz3,4, Hans-Josef Feistritzer1,2, Georg Stachel1,2, Philipp Hartung1,2, Ingo Eitel3,4, Christoph Marquetand3,4, Holger Nef5, Oliver Doerr5, Alexander Lauten4,6, Ulf Landmesser4,6, Mohamed Abdel-Wahab1,2, Marcus Sandri1,2, David Holzhey1,2, Michael Borger1,2, Hüseyin Ince7, Alper Öner7, Roza Meyer-Saraei3,4, Harm Wienbergen8, Andreas Fach8, Norbert Frey4,9, Inke R König4,10, Reinhard Vonthein10, Yvonne Rückert2, Anne-Kathrin Funkat2, Suzanne de Waha-Thiele3,4, Steffen Desch1,2,4. 1. Heart Center Leipzig at University of Leipzig, Strümpellstr. 39, 04289 Leipzig, Germany. 2. Leipzig Heart Institute, Russenstraße 69a, D-04289 Leipzig, Germany. 3. University Clinic Schleswig-Holstein and University Heart Center Lübeck, Ratzeburger Allee 160, D-23538 Lübeck, Germany. 4. German Center for Cardiovascular Research (DZHK), Ratzeburger Allee 160, D-23538 Lübeck, Germany. 5. Medizinische Klinik I, Abteilung für Kardiologie, Universitätsklinikum Marburg/Gießen, Klinikstr. 33, D-35392 Gießen, Germany. 6. Universitätsklinikum Charité, Campus Benjamin Franklin, Hindenburgdamm 30, D-12200 Berlin, Germany. 7. Medizinische Klinik I im Zentrum für Innere Medizin (ZIM), Universitätsklinikum Rostock, Ernst-Heydemann-Str. 6, D-18057 Rostock, Germany. 8. Klinikum Links der Weser, Herzzentrum Bremen, Senator-Wessling-Str. 1, D-28277 Bremen, Germany. 9. Department of Cardiology, University Clinic Schleswig-Holstein, Campus Kiel, Schittenhelmstr. 12, D-24105 Kiel, Germany. 10. Institut für Medizinische Biometrie und Statistik, Universität zu Lübeck, Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Ratzeburger Allee 160, D-23562 Lübeck, Germany.
Abstract
AIMS: Transcatheter aortic valve implantation (TAVI) has emerged as established treatment option in patients with symptomatic aortic stenosis. Technical developments in valve design have addressed previous limitations such as suboptimal deployment, conduction disturbances, and paravalvular leakage. However, there are only limited data available for the comparison of newer generation self-expandable valve (SEV) and balloon-expandable valve (BEV). METHODS AND RESULTS: SOLVE-TAVI is a multicentre, open-label, 2 × 2 factorial, randomized trial of 447 patients with aortic stenosis undergoing transfemoral TAVI comparing SEV (Evolut R, Medtronic Inc., Minneapolis, MN, USA) with BEV (Sapien 3, Edwards Lifesciences, Irvine, CA, USA). The primary efficacy composite endpoint of all-cause mortality, stroke, moderate/severe prosthetic valve regurgitation, and permanent pacemaker implantation at 30 days was powered for equivalence (equivalence margin 10% with significance level 0.05). The primary composite endpoint occurred in 28.4% of SEV patients and 26.1% of BEV patients meeting the prespecified criteria of equivalence [rate difference -2.39 (90% confidence interval, CI -9.45 to 4.66); Pequivalence = 0.04]. Event rates for the individual components were as follows: all-cause mortality 3.2% vs. 2.3% [rate difference -0.93 (90% CI -4.78 to 2.92); Pequivalence < 0.001], stroke 0.5% vs. 4.7% [rate difference 4.20 (90% CI 0.12 to 8.27); Pequivalence = 0.003], moderate/severe paravalvular leak 3.4% vs. 1.5% [rate difference -1.89 (90% CI -5.86 to 2.08); Pequivalence = 0.0001], and permanent pacemaker implantation 23.0% vs. 19.2% [rate difference -3.85 (90% CI -10.41 to 2.72) in SEV vs. BEV patients; Pequivalence = 0.06]. CONCLUSION: In patients with aortic stenosis undergoingtransfemoral TAVI, newer generation SEV and BEV are equivalent for the primary valve-related efficacy endpoint. These findings support the safe application of these newer generation percutaneous valves in the majority of patients with some specific preferences based on individual valve anatomy. Published on behalf of the European Society of Cardiology. All rights reserved.
RCT Entities:
AIMS: Transcatheter aortic valve implantation (TAVI) has emerged as established treatment option in patients with symptomatic aortic stenosis. Technical developments in valve design have addressed previous limitations such as suboptimal deployment, conduction disturbances, and paravalvular leakage. However, there are only limited data available for the comparison of newer generation self-expandable valve (SEV) and balloon-expandable valve (BEV). METHODS AND RESULTS: SOLVE-TAVI is a multicentre, open-label, 2 × 2 factorial, randomized trial of 447 patients with aortic stenosis undergoing transfemoral TAVI comparing SEV (Evolut R, Medtronic Inc., Minneapolis, MN, USA) with BEV (Sapien 3, Edwards Lifesciences, Irvine, CA, USA). The primary efficacy composite endpoint of all-cause mortality, stroke, moderate/severe prosthetic valve regurgitation, and permanent pacemaker implantation at 30 days was powered for equivalence (equivalence margin 10% with significance level 0.05). The primary composite endpoint occurred in 28.4% of SEV patients and 26.1% of BEV patients meeting the prespecified criteria of equivalence [rate difference -2.39 (90% confidence interval, CI -9.45 to 4.66); Pequivalence = 0.04]. Event rates for the individual components were as follows: all-cause mortality 3.2% vs. 2.3% [rate difference -0.93 (90% CI -4.78 to 2.92); Pequivalence < 0.001], stroke 0.5% vs. 4.7% [rate difference 4.20 (90% CI 0.12 to 8.27); Pequivalence = 0.003], moderate/severe paravalvular leak 3.4% vs. 1.5% [rate difference -1.89 (90% CI -5.86 to 2.08); Pequivalence = 0.0001], and permanent pacemaker implantation 23.0% vs. 19.2% [rate difference -3.85 (90% CI -10.41 to 2.72) in SEV vs. BEV patients; Pequivalence = 0.06]. CONCLUSION: In patients with aortic stenosis undergoing transfemoral TAVI, newer generation SEV and BEV are equivalent for the primary valve-related efficacy endpoint. These findings support the safe application of these newer generation percutaneous valves in the majority of patients with some specific preferences based on individual valve anatomy. Published on behalf of the European Society of Cardiology. All rights reserved.
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