近日，丹麦奥胡斯大学教授Henrik Nissen团队发现，SAPIEN 3与Myval经导管心脏瓣膜在经导管主动脉瓣植入术中的比较（COMPARE-TAVI 1）：一项多中心、随机、非劣效性试验。相关论文于2025年4月2日发表于国际顶尖学术期刊《柳叶刀》杂志上。

背景：经导管主动脉瓣植入术（TAVI）是治疗严重主动脉瓣狭窄和退行性主动脉假体的一种指导方法。当新的经导管心脏瓣膜（THV）平台用于TAVI时，应将其与最佳实践的当代THV进行短期和长期性能比较。COMPARE-TAVI 1试验旨在对SAPIEN 3或SAPIEN 3 Ultra THV与Myval或Myval Octacor THV进行正面比较。

方法：这项多中心、全患者、随机、非劣效性试验在丹麦的三所大学医院进行。符合条件的患者年龄为18岁或以上，计划进行经股TAVI，并符合SAPIEN 3 THV或Myval THV治疗的条件。患者被随机分配（1:1）接受SAPIEN 3（直径29 mm）或SAPIEN 3 Ultra（直径20 mm、23 mm或26 mm）THV或Myval或Myval Octacor THV（直径20 - 32 mm）治疗。TAVI手术按照当地惯例在局部麻醉下进行，除非有小叶撕裂。根据第三瓣膜学术研究协会的标准，主要终点是1年内死亡、中风、中度或重度主动脉瓣反流或中度或重度血流动力学THV恶化。所有接受THV治疗的患者均被纳入意向治疗分析，所有接受随机分配治疗的患者均被纳入方案分析。预期事件率为13%，预先规定的非劣效性裕度为5.3%。

发现：在2020年6月15日至2023年11月3日期间，1031名患者入组。由于与专利有关的法律程序，招生被暂停了两次。在1031例患者中，517例患者被随机分配到SAPIEN 3 THVs， 514例患者被随机分配到Myval THVs。患者年龄中位数为86.1岁（IQR为77.6 ~ 85.6），1031例患者中女性415例（40%），男性616例（60%）。517例随机分配到SAPIEN 3 THV组的患者中有67例（13%）出现主要终点，而514例随机分配到Myval THV组的患者中有71例（14%）出现主要终点(风险差- 0.9%；p_{non-inferiority} = 0.019)。

研究结果表明，在死亡、卒中、中度或重度主动脉瓣反流、中度或重度血流动力学THV恶化的1年综合终点方面，Myval THV不逊于SAPIEN 3 THV。

附：英文原文

Title: SAPIEN 3 versus Myval transcatheter heart valves for transcatheter aortic valve implantation (COMPARE-TAVI 1): a multicentre, randomised, non-inferiority trial

Author: Christian Juhl Terkelsen, Philip Freeman, Jordi Sanchez Dahl, Troels Thim, Bjarne Linde Nrgaard, Nils Sofus Borg Mogensen, Mariann Tang, Ashkan Eftekhari, Jonas Agerlund Povlsen, Steen Hvitfeldt Poulsen, Lars Pedersen, Jakob Hjort, Julia Ellert, Evald Hj Christiansen, Henrik Toft Srensen, Henrik Nissen

Issue&Volume: 2025-04-02

Abstract: Background

Transcatheter aortic valve implantation (TAVI) is a guideline-directed treatment for severe aortic stenosis and degenerated aortic bioprostheses. When new transcatheter heart valve (THV) platforms for TAVI are launched, they should be compared with best-in-practice contemporary THVs for their short-term and long-term performance. The COMPARE-TAVI 1 trial was designed to provide a head-to-head comparison of the SAPIEN 3 or SAPIEN 3 Ultra THVs and the Myval or Myval Octacor THVs.

Methods

This multicentre, all-comers, randomised, non-inferiority trial was done at three university hospitals in Denmark. Eligible patients were aged 18 years or older, scheduled for transfemoral TAVI, and eligible for treatment with SAPIEN 3 THVs or Myval THVs. Patients were randomly assigned (1:1) to treatment with SAPIEN 3 (29 mm diameter) or SAPIEN 3 Ultra (20 mm, 23 mm, or 26 mm diameter) THVs or Myval or Myval Octacor THVs (20–32 mm diameter). The TAVI procedure was performed according to local practice and under local anaesthesia unless leaflet laceration was performed. The primary endpoint was a composite of death, stroke, moderate or severe aortic regurgitation, or moderate or severe haemodynamic THV deterioration at 1 year according to Third Valve Academic Research Consortium criteria. All patients assigned to THV treatment were included in the intention-to-treat analysis, and all patients who were treated as randomly assigned were included in the per-protocol analysis. With an expected event rate of 13%, the prespecified non-inferiority margin was 5·3%. This trial is registered with ClinicalTrials.gov, NCT04443023, and is closed to accrual.

Findings

Between June 15, 2020, and Nov 3, 2023, 1031 patients were enrolled. Enrolment was paused twice because of patent-related legal proceedings. Of 1031 patients, 517 patients were randomly assigned to SAPIEN 3 THVs and 514 to Myval THVs. The median patient age was 81·6 years (IQR 77·6–85·0), and 415 (40%) of 1031 patients were female and 616 (60%) were male. The primary endpoint occurred in 67 (13%) of 517 patients randomly assigned to SAPIEN 3 THVs versus 71 (14%) of 514 patients randomly assigned to Myval THVs (risk difference –0·9% [one-sided upper 95% CI 4·4%]; pnon-inferiority=0·019).

Interpretation

Myval THVs were non-inferior to SAPIEN 3 THVs in terms of a 1-year composite endpoint of death, stroke, moderate or severe aortic regurgitation, or moderate or severe haemodynamic THV deterioration.

DOI: 10.1016/S0140-6736(25)00106-0

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)00106-0/abstract