Comparison of newer generation self-expandable vs. balloon-expandable valves in transcatheter aortic valve implantation: the randomized SOLVE-TAVI trial

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. Howeve...

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Published in:	European heart journal Vol. 41; no. 20; p. 1890
Main Authors:	Thiele, Holger, Kurz, Thomas, Feistritzer, Hans-Josef, Stachel, Georg, Hartung, Philipp, Eitel, Ingo, Marquetand, Christoph, Nef, Holger, Doerr, Oliver, Lauten, Alexander, Landmesser, Ulf, Abdel-Wahab, Mohamed, Sandri, Marcus, Holzhey, David, Borger, Michael, Ince, Hüseyin, Öner, Alper, Meyer-Saraei, Roza, Wienbergen, Harm, Fach, Andreas, Frey, Norbert, König, Inke R, Vonthein, Reinhard, Rückert, Yvonne, Funkat, Anne-Kathrin, de Waha-Thiele, Suzanne, Desch, Steffen
Format:	Journal Article
Language:	English
Published:	England 21.05.2020
Subjects:	Aortic Valve - surgery Aortic Valve Stenosis - surgery Heart Valve Prosthesis Humans Postoperative Complications - epidemiology Prosthesis Design Transcatheter Aortic Valve Replacement - adverse effects Treatment Outcome Aortic stenosis Transcatheter aortic valve implantation Stroke Prognosis Pacemaker implantation Transcatheter aortic valve replacement
ISSN:	1522-9645, 1522-9645
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Abstract	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). 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]. 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.
AbstractList	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).AIMSTranscatheter 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).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].METHODS AND RESULTSSOLVE-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].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.CONCLUSIONIn 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. 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). 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]. 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.
Author	Eitel, Ingo Stachel, Georg Holzhey, David Feistritzer, Hans-Josef Kurz, Thomas Doerr, Oliver Wienbergen, Harm Borger, Michael Ince, Hüseyin Lauten, Alexander Thiele, Holger Rückert, Yvonne Abdel-Wahab, Mohamed Fach, Andreas Hartung, Philipp Marquetand, Christoph Landmesser, Ulf Nef, Holger Meyer-Saraei, Roza de Waha-Thiele, Suzanne Vonthein, Reinhard Öner, Alper Desch, Steffen Frey, Norbert König, Inke R Funkat, Anne-Kathrin Sandri, Marcus
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Lübeck, Germany – sequence: 7 givenname: Christoph surname: Marquetand fullname: Marquetand, Christoph organization: German Center for Cardiovascular Research (DZHK), Ratzeburger Allee 160, D-23538 Lübeck, Germany – sequence: 8 givenname: Holger surname: Nef fullname: Nef, Holger organization: Medizinische Klinik I, Abteilung für Kardiologie, Universitätsklinikum Marburg/Gießen, Klinikstr. 33, D-35392 Gießen, Germany – sequence: 9 givenname: Oliver surname: Doerr fullname: Doerr, Oliver organization: Medizinische Klinik I, Abteilung für Kardiologie, Universitätsklinikum Marburg/Gießen, Klinikstr. 33, D-35392 Gießen, Germany – sequence: 10 givenname: Alexander surname: Lauten fullname: Lauten, Alexander organization: Universitätsklinikum Charité, Campus Benjamin Franklin, Hindenburgdamm 30, D-12200 Berlin, Germany – sequence: 11 givenname: Ulf surname: Landmesser fullname: Landmesser, Ulf organization: Universitätsklinikum Charité, Campus Benjamin Franklin, Hindenburgdamm 30, D-12200 Berlin, Germany – sequence: 12 givenname: Mohamed surname: Abdel-Wahab fullname: Abdel-Wahab, Mohamed organization: Leipzig Heart Institute, Russenstraße 69a, D-04289 Leipzig, Germany – sequence: 13 givenname: Marcus surname: Sandri fullname: Sandri, Marcus organization: Leipzig Heart Institute, Russenstraße 69a, D-04289 Leipzig, Germany – sequence: 14 givenname: David surname: Holzhey fullname: Holzhey, David organization: Leipzig Heart Institute, Russenstraße 69a, D-04289 Leipzig, Germany – sequence: 15 givenname: Michael surname: Borger fullname: Borger, Michael organization: Leipzig Heart Institute, Russenstraße 69a, D-04289 Leipzig, Germany – sequence: 16 givenname: Hüseyin surname: Ince fullname: Ince, Hüseyin organization: Medizinische Klinik I im Zentrum für Innere Medizin (ZIM), Universitätsklinikum Rostock, Ernst-Heydemann-Str. 6, D-18057 Rostock, Germany – sequence: 17 givenname: Alper surname: Öner fullname: Öner, Alper organization: Medizinische Klinik I im Zentrum für Innere Medizin (ZIM), Universitätsklinikum Rostock, Ernst-Heydemann-Str. 6, D-18057 Rostock, Germany – sequence: 18 givenname: Roza surname: Meyer-Saraei fullname: Meyer-Saraei, Roza organization: German Center for Cardiovascular Research (DZHK), Ratzeburger Allee 160, D-23538 Lübeck, Germany – sequence: 19 givenname: Harm surname: Wienbergen fullname: Wienbergen, Harm organization: Klinikum Links der Weser, Herzzentrum Bremen, Senator-Wessling-Str. 1, D-28277 Bremen, Germany – sequence: 20 givenname: Andreas surname: Fach fullname: Fach, Andreas organization: Klinikum Links der Weser, Herzzentrum Bremen, Senator-Wessling-Str. 1, D-28277 Bremen, Germany – sequence: 21 givenname: Norbert surname: Frey fullname: Frey, Norbert organization: Department of Cardiology, University Clinic Schleswig-Holstein, Campus Kiel, Schittenhelmstr. 12, D-24105 Kiel, Germany – sequence: 22 givenname: Inke R surname: König fullname: König, Inke R organization: Institut für Medizinische Biometrie und Statistik, Universität zu Lübeck, Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Ratzeburger Allee 160, D-23562 Lübeck, Germany – sequence: 23 givenname: Reinhard surname: Vonthein fullname: Vonthein, Reinhard organization: Institut für Medizinische Biometrie und Statistik, Universität zu Lübeck, Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Ratzeburger Allee 160, D-23562 Lübeck, Germany – sequence: 24 givenname: Yvonne surname: Rückert fullname: Rückert, Yvonne organization: Leipzig Heart Institute, Russenstraße 69a, D-04289 Leipzig, Germany – sequence: 25 givenname: Anne-Kathrin surname: Funkat fullname: Funkat, Anne-Kathrin organization: Leipzig Heart Institute, Russenstraße 69a, D-04289 Leipzig, Germany – sequence: 26 givenname: Suzanne surname: de Waha-Thiele fullname: de Waha-Thiele, Suzanne organization: German Center for Cardiovascular Research (DZHK), Ratzeburger Allee 160, D-23538 Lübeck, Germany – sequence: 27 givenname: Steffen surname: Desch fullname: Desch, Steffen organization: German Center for Cardiovascular Research (DZHK), Ratzeburger Allee 160, D-23538 Lübeck, Germany
BackLink	https://www.ncbi.nlm.nih.gov/pubmed/32049283$$D View this record in MEDLINE/PubMed
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Keywords	Aortic stenosis Transcatheter aortic valve implantation Stroke Prognosis Pacemaker implantation Transcatheter aortic valve replacement
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References	32259209 - Eur Heart J. 2020 May 21;41(20):1900-1902 32808024 - Eur Heart J. 2020 Dec 1;41(45):4360-4361 32808007 - Eur Heart J. 2020 Dec 1;41(45):4362
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Snippet	Transcatheter aortic valve implantation (TAVI) has emerged as established treatment option in patients with symptomatic aortic stenosis. Technical developments...
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SubjectTerms	Aortic Valve - surgery Aortic Valve Stenosis - surgery Heart Valve Prosthesis Humans Postoperative Complications - epidemiology Prosthesis Design Transcatheter Aortic Valve Replacement - adverse effects Treatment Outcome
Title	Comparison of newer generation self-expandable vs. balloon-expandable valves in transcatheter aortic valve implantation: the randomized SOLVE-TAVI trial
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