Niels van Royen, Ignacio J Amat-Santos, Martin Hudec, Matjaz Bunc, Alexander Ijsselmuiden, Peep Laanmets, Daniel Unic, Béla Merkely, Renicus S Hermanides, Vlasis Ninios, Marcin Protasiewicz, Benno J W M Rensing, Pedro L Martin, Fausto Feres, Manuel De Sousa, Eric Van Belle, Axel Linke, Alfonso Ielasi, Matteo Montorfano, Mark Webster, Konstantinos Toutouzas, Emmanuel Teiger, Francesco Bedogni, Michiel Voskuil, Manuel Pan, Oskar Angerås, Won-Keun Kim, Jürgen Rothe, Ivica Kristić, Vicente Peral, Ben J L Van den Branden, Dirk Westermann, Barbara Bellini, Mario Garcia-Gomez, Akihiro Tobe, Tsung-Ying Tsai, Scot Garg, Ashokkumar Thakkar, Udita Chandra, Marie-Claude Morice, Osama Soliman, Yoshinobu Onuma, Patrick W Serruys, Andreas Baumbach
{"title":"新型 Myval THV 系列与 SAPIEN THV 系列和 Evolut THV 系列在重度主动脉瓣狭窄患者中的早期疗效比较。","authors":"Niels van Royen, Ignacio J Amat-Santos, Martin Hudec, Matjaz Bunc, Alexander Ijsselmuiden, Peep Laanmets, Daniel Unic, Béla Merkely, Renicus S Hermanides, Vlasis Ninios, Marcin Protasiewicz, Benno J W M Rensing, Pedro L Martin, Fausto Feres, Manuel De Sousa, Eric Van Belle, Axel Linke, Alfonso Ielasi, Matteo Montorfano, Mark Webster, Konstantinos Toutouzas, Emmanuel Teiger, Francesco Bedogni, Michiel Voskuil, Manuel Pan, Oskar Angerås, Won-Keun Kim, Jürgen Rothe, Ivica Kristić, Vicente Peral, Ben J L Van den Branden, Dirk Westermann, Barbara Bellini, Mario Garcia-Gomez, Akihiro Tobe, Tsung-Ying Tsai, Scot Garg, Ashokkumar Thakkar, Udita Chandra, Marie-Claude Morice, Osama Soliman, Yoshinobu Onuma, Patrick W Serruys, Andreas Baumbach","doi":"10.4244/EIJ-D-24-00951","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>There are limited head-to-head randomised trials comparing the performance of different transcatheter heart valves (THVs).</p><p><strong>Aims: </strong>We aimed to evaluate the non-inferiority of the balloon-expandable Myval THV series compared to the balloon-expandable SAPIEN THV series or the self-expanding Evolut THV series.</p><p><strong>Methods: </strong>The LANDMARK trial randomised 768 patients in a 1:1 ratio, (Myval THV series [n=384] vs contemporary series with 50% SAPIEN THV series [n=192] and 50% Evolut THV series [n=192]). The non-inferiority of Myval over the SAPIEN or Evolut THV series in terms of the 30-day primary composite safety and effectiveness endpoint as per the third Valve Academic Research Consortium (VARC-3) was tested in an intention-to-treat population with a predefined statistical power of 80% (1-sided alpha of 5%) for a non-inferiority margin of 10.44%.</p><p><strong>Results: </strong>The Myval THV series achieved non-inferiority for the primary composite endpoint over the SAPIEN THV series (24.7% vs 24.1%, risk difference [95% confidence interval {CI}]: 0.6% [not applicable {NA} to 8.0]; p=0.0033) and the Evolut THV series (24.7% vs 30.0%, risk difference [95% CI]: -5.3% [NA to 2.5]; p<0.0001). The incidences of pacemaker implantation were comparable (Myval THV series: 15.0%, SAPIEN THV series: 17.3%, Evolut THV series: 16.8%). At 30 days, the mean pressure gradient and effective orifice area were significantly better with the Myval THV series compared to the SAPIEN THV series (p<0.0001) and better with the Evolut THV series than with the Myval THV series (p<0.0001). At 30 days, the proportion of moderate to severe prosthetic valve regurgitation was numerically higher with the Evolut THV series compared to the Myval THV series (7.4% vs 3.4%; p=0.06), while not significantly different between the Myval THV series and the SAPIEN THV series (3.4% vs 1.6%; p=0.32).</p><p><strong>Conclusions: </strong>The Myval THV series is non-inferior to the SAPIEN THV series and the Evolut THV series in terms of the primary composite endpoint at 30 days.</p><p><strong>Clinical trial registration: </strong>ClinicalTrials.gov: NCT04275726; EudraCT number 2020-000,137-40.</p>","PeriodicalId":54378,"journal":{"name":"Eurointervention","volume":" ","pages":""},"PeriodicalIF":7.6000,"publicationDate":"2024-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Early outcomes of the novel Myval THV series compared to SAPIEN THV series and Evolut THV series in individuals with severe aortic stenosis.\",\"authors\":\"Niels van Royen, Ignacio J Amat-Santos, Martin Hudec, Matjaz Bunc, Alexander Ijsselmuiden, Peep Laanmets, Daniel Unic, Béla Merkely, Renicus S Hermanides, Vlasis Ninios, Marcin Protasiewicz, Benno J W M Rensing, Pedro L Martin, Fausto Feres, Manuel De Sousa, Eric Van Belle, Axel Linke, Alfonso Ielasi, Matteo Montorfano, Mark Webster, Konstantinos Toutouzas, Emmanuel Teiger, Francesco Bedogni, Michiel Voskuil, Manuel Pan, Oskar Angerås, Won-Keun Kim, Jürgen Rothe, Ivica Kristić, Vicente Peral, Ben J L Van den Branden, Dirk Westermann, Barbara Bellini, Mario Garcia-Gomez, Akihiro Tobe, Tsung-Ying Tsai, Scot Garg, Ashokkumar Thakkar, Udita Chandra, Marie-Claude Morice, Osama Soliman, Yoshinobu Onuma, Patrick W Serruys, Andreas Baumbach\",\"doi\":\"10.4244/EIJ-D-24-00951\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>There are limited head-to-head randomised trials comparing the performance of different transcatheter heart valves (THVs).</p><p><strong>Aims: </strong>We aimed to evaluate the non-inferiority of the balloon-expandable Myval THV series compared to the balloon-expandable SAPIEN THV series or the self-expanding Evolut THV series.</p><p><strong>Methods: </strong>The LANDMARK trial randomised 768 patients in a 1:1 ratio, (Myval THV series [n=384] vs contemporary series with 50% SAPIEN THV series [n=192] and 50% Evolut THV series [n=192]). The non-inferiority of Myval over the SAPIEN or Evolut THV series in terms of the 30-day primary composite safety and effectiveness endpoint as per the third Valve Academic Research Consortium (VARC-3) was tested in an intention-to-treat population with a predefined statistical power of 80% (1-sided alpha of 5%) for a non-inferiority margin of 10.44%.</p><p><strong>Results: </strong>The Myval THV series achieved non-inferiority for the primary composite endpoint over the SAPIEN THV series (24.7% vs 24.1%, risk difference [95% confidence interval {CI}]: 0.6% [not applicable {NA} to 8.0]; p=0.0033) and the Evolut THV series (24.7% vs 30.0%, risk difference [95% CI]: -5.3% [NA to 2.5]; p<0.0001). The incidences of pacemaker implantation were comparable (Myval THV series: 15.0%, SAPIEN THV series: 17.3%, Evolut THV series: 16.8%). At 30 days, the mean pressure gradient and effective orifice area were significantly better with the Myval THV series compared to the SAPIEN THV series (p<0.0001) and better with the Evolut THV series than with the Myval THV series (p<0.0001). 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Early outcomes of the novel Myval THV series compared to SAPIEN THV series and Evolut THV series in individuals with severe aortic stenosis.
Background: There are limited head-to-head randomised trials comparing the performance of different transcatheter heart valves (THVs).
Aims: We aimed to evaluate the non-inferiority of the balloon-expandable Myval THV series compared to the balloon-expandable SAPIEN THV series or the self-expanding Evolut THV series.
Methods: The LANDMARK trial randomised 768 patients in a 1:1 ratio, (Myval THV series [n=384] vs contemporary series with 50% SAPIEN THV series [n=192] and 50% Evolut THV series [n=192]). The non-inferiority of Myval over the SAPIEN or Evolut THV series in terms of the 30-day primary composite safety and effectiveness endpoint as per the third Valve Academic Research Consortium (VARC-3) was tested in an intention-to-treat population with a predefined statistical power of 80% (1-sided alpha of 5%) for a non-inferiority margin of 10.44%.
Results: The Myval THV series achieved non-inferiority for the primary composite endpoint over the SAPIEN THV series (24.7% vs 24.1%, risk difference [95% confidence interval {CI}]: 0.6% [not applicable {NA} to 8.0]; p=0.0033) and the Evolut THV series (24.7% vs 30.0%, risk difference [95% CI]: -5.3% [NA to 2.5]; p<0.0001). The incidences of pacemaker implantation were comparable (Myval THV series: 15.0%, SAPIEN THV series: 17.3%, Evolut THV series: 16.8%). At 30 days, the mean pressure gradient and effective orifice area were significantly better with the Myval THV series compared to the SAPIEN THV series (p<0.0001) and better with the Evolut THV series than with the Myval THV series (p<0.0001). At 30 days, the proportion of moderate to severe prosthetic valve regurgitation was numerically higher with the Evolut THV series compared to the Myval THV series (7.4% vs 3.4%; p=0.06), while not significantly different between the Myval THV series and the SAPIEN THV series (3.4% vs 1.6%; p=0.32).
Conclusions: The Myval THV series is non-inferior to the SAPIEN THV series and the Evolut THV series in terms of the primary composite endpoint at 30 days.
Clinical trial registration: ClinicalTrials.gov: NCT04275726; EudraCT number 2020-000,137-40.
期刊介绍：
EuroIntervention Journal is an international, English language, peer-reviewed journal whose aim is to create a community of high quality research and education in the field of percutaneous and surgical cardiovascular interventions.
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