新型Myval经导管心脏瓣膜系列与SAPIEN经导管心脏瓣膜系列和Evolut经导管心脏瓣膜系列在严重主动脉瓣狭窄患者中的早期疗效比较。
Early outcomes of the novel Myval THV series compared to SAPIEN THV series and Evolut THV series in individuals with severe aortic stenosis.
作者信息
Royen Niels van, Amat-Santos Ignacio J, Hudec Martin, Bunc Matjaz, Ijsselmuiden Alexander, Laanmets Peep, Unic Daniel, Merkely Béla, Hermanides Renicus S, Ninios Vlasis, Protasiewicz Marcin, Rensing Benno J W M, Martin Pedro L, Feres Fausto, Sousa Manuel De, Belle Eric Van, Linke Axel, Ielasi Alfonso, Montorfano Matteo, Webster Mark, Toutouzas Konstantinos, Teiger Emmanuel, Bedogni Francesco, Voskuil Michiel, Pan Manuel, Angerås Oskar, Kim Won-Keun, Rothe Jürgen, Kristić Ivica, Peral Vicente, Van den Branden Ben J L, Westermann Dirk, Bellini Barbara, Garcia-Gomez Mario, Tobe Akihiro, Tsai Tsung-Ying, Garg Scot, Thakkar Ashokkumar, Chandra Udita, Morice Marie-Claude, Soliman Osama, Onuma Yoshinobu, Serruys Patrick W, Baumbach Andreas
机构信息
Department of Cardiology, Radboud University Hospital, Nijmegen, the Netherlands.
Centro de Investigación Biomédica en Red - Enfermedades Cardiovasculares (CIBERCV), Instituto de Salud Carlos III, Madrid, Spain.
出版信息
EuroIntervention. 2025 Jan 20;21(2):e105-e118. doi: 10.4244/EIJ-D-24-00951.
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.
背景
比较不同经导管心脏瓣膜（THV）性能的直接头对头随机试验有限。
目的
我们旨在评估球囊扩张式Myval THV系列与球囊扩张式SAPIEN THV系列或自膨式Evolut THV系列相比的非劣效性。
方法
LANDMARK试验以1:1的比例将768例患者随机分组，（Myval THV系列[n = 384]与当代系列，其中50%为SAPIEN THV系列[n = 192]，50%为Evolut THV系列[n = 192]）。在预先设定统计效能为80%（单侧α为5%）、非劣效界值为10.44%的意向性治疗人群中，根据第三个瓣膜学术研究联盟（VARC - 3）标准，测试Myval相对于SAPIEN或Evolut THV系列在30天主要复合安全性和有效性终点方面的非劣效性。
结果
Myval THV系列在主要复合终点方面相对于SAPIEN THV系列实现了非劣效性（24.7%对24.1%，风险差异[95%置信区间{CI}]：0.6%[不可用{NA}至8.0]；p = 0.0033）以及相对于Evolut THV系列（24.7%对30.0%，风险差异[95% CI]： - 5.3%[NA至2.5]；p < 0.0001）。起搏器植入发生率相当（Myval THV系列：15.0%，SAPIEN THV系列：17.3%，Evolut THV系列：16.8%）。在30天时，Myval THV系列的平均压力阶差和有效瓣口面积相比于SAPIEN THV系列显著更好（p < 0.0001），且Evolut THV系列相比于Myval THV系列更好（p < 0.0001）。在30天时，Evolut THV系列中度至重度人工瓣膜反流的比例在数值上高于Myval THV系列（7.4%对3.4%；p = 0.06），而Myval THV系列与SAPIEN THV系列之间无显著差异（3.4%对1.6%；p = 0.32）。
结论
Myval THV系列在30天主要复合终点方面不劣于SAPIEN THV系列和Evolut THV系列。
临床试验注册
ClinicalTrials.gov：NCT04275726；EudraCT编号2020 - 000,137 - 40。
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