Raschpichler Matthias, de Waha Suzanne, Blankenberg Stefan, Diniz Marcio A, Bagiella Emilia, Gelijns Annetine C, Calsavara Vinicius F, Gupta Aakriti, Schofer Niklas, Kaneko Tsuyoshi, Abdel-Wahab Mohamed, Thiele Holger, Makkar Raj, Borger Michael A
Department of Cardiac Surgery Heart Center Leipzig at Leipzig University Leipzig Germany.
Department of Rhythmology University Hospital Schleswig-Holstein, Campus Lübeck Lübeck Germany.
J Am Heart Assoc. 2025 May 20;14(10):e040954. doi: 10.1161/JAHA.125.040954. Epub 2025 May 15.
BACKGROUND: Redo surgical aortic valve replacement (rSAVR) has for long been the therapeutic reference standard for degenerated surgical aortic bioprostheses. Valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) has emerged as an alternative for patients at high surgical risk due to its lower invasiveness. The long-term clinical efficacy of ViV-TAVR in patients at low to intermediate surgical risk remains unknown. METHODS AND RESULTS: To compare clinical outcomes of redo surgical aortic valve replacement versus ViV-TAVR in low- to intermediate-risk patients with degenerated surgical aortic bioprostheses. REPEAT (Repeat Intervention for Deteriorated Surgical Bioprosthetic Aortic Valves) is an investigator-initiated, international, multicenter, randomized, parallel, open-label trial. A total of 890 patients aged <75 years with a failed surgical aortic bioprosthesis due to structural valve degeneration and low to intermediate surgical risk (ie, Society of Thoracic Surgeons predicted risk of death of <8%) will be randomly assigned in a 1:1 ratio to either redo surgical aortic valve replacement or ViV-TAVR. The primary end point of REPEAT is a composite of all-cause death, stroke (including both disabling and nondisabling), myocardial infarction, and rehospitalization for heart failure or aortic valve reintervention at 5 years, based on Valve Academic Research Consortium-3 definitions. Secondary end points include each of the individual components of the primary composite end point, Valve Academic Research Consortium-3-based conduction disturbances and arrhythmia, Valve Academic Research Consortium-3-based wound and bleeding complications, functional status (ie, 6-minute walk test, Kansas City Cardiomyopathy questionnaire), and treatment costs. CONCLUSIONS: The REPEAT trial has been designed to test the hypothesis that redo surgical aortic valve replacement is superior to ViV-TAVR regarding clinical outcomes at 5 years in patients with degenerated surgical aortic bioprostheses and low to intermediate surgical risk.
背景：再次手术主动脉瓣置换术（rSAVR）长期以来一直是退化性外科主动脉生物瓣膜的治疗参考标准。经导管主动脉瓣置入术（ViV-TAVR）因其较低的侵入性，已成为高手术风险患者的一种替代选择。ViV-TAVR在低至中度手术风险患者中的长期临床疗效尚不清楚。 方法与结果：为比较低至中度风险的退化性外科主动脉生物瓣膜患者再次手术主动脉瓣置换术与ViV-TAVR的临床结局。REPEAT（退化性外科生物人工主动脉瓣膜重复干预）是一项由研究者发起的、国际多中心、随机、平行、开放标签试验。共有890名年龄<75岁、因结构性瓣膜退变导致外科主动脉生物瓣膜功能衰竭且手术风险低至中度（即胸外科医师协会预测死亡风险<8%）的患者将按1:1比例随机分配至再次手术主动脉瓣置换术或ViV-TAVR组。REPEAT的主要终点是根据瓣膜学术研究联盟-3的定义，在5年时全因死亡、卒中（包括致残性和非致残性）、心肌梗死以及因心力衰竭或主动脉瓣再次干预而再次住院的复合终点。次要终点包括主要复合终点的各个单独组成部分、基于瓣膜学术研究联盟-3的传导障碍和心律失常、基于瓣膜学术研究联盟-3的伤口和出血并发症、功能状态（即6分钟步行试验、堪萨斯城心肌病问卷）以及治疗费用。 结论：REPEAT试验旨在检验以下假设：对于退化性外科主动脉生物瓣膜且手术风险低至中度的患者，再次手术主动脉瓣置换术在5年临床结局方面优于ViV-TAVR。
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