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。

IF 7.6 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Eurointervention Pub Date : 2024-11-26 DOI:10.4244/EIJ-D-24-00951

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

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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%). 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引用次数: 0

摘要

背景：比较不同经导管心脏瓣膜（THV）性能的头对头随机试验非常有限。目的：我们旨在评估可球囊扩张的Myval THV系列与可球囊扩张的SAPIEN THV系列或自扩张的Evolut THV系列相比的非劣效性：LANDMARK试验以1:1的比例随机抽取了768名患者（Myval THV系列[n=384]与50% SAPIEN THV系列[n=192]和50% Evolut THV系列[n=192]的当代系列）。根据第三届瓣膜学术研究联盟（VARC-3）的规定，在意向治疗人群中测试了Myval与SAPIEN或Evolut THV系列相比在30天主要安全性和有效性复合终点方面的非劣效性，预定的统计功率为80%（单侧α为5%），非劣效性差值为10.44%：结果：与 SAPIEN THV 系列相比，Myval THV 系列在主要复合终点上达到了非劣效性（24.7% vs 24.1%，风险差异[95% 置信区间{CI}]：0.6% [不适用{CI}]）：0.6%[不适用{NA}至8.0]；p=0.0033）和Evolut THV系列（24.7% vs 30.0%，风险差异[95% CI]：-5.3%[不适用至2.5]；p结论：就30天的主要复合终点而言，Myval THV系列不劣于SAPIEN THV系列和Evolut THV系列：临床试验注册：ClinicalTrials.gov：临床试验注册：ClinicalTrials.gov：NCT04275726；EudraCT 编号：2020-000,137-40。

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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.

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来源期刊

Eurointervention CARDIAC & CARDIOVASCULAR SYSTEMS-

CiteScore

10.30

自引率

4.80%

发文量

380

审稿时长

3-8 weeks

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.