Nappi Francesco, Bourgois Camille, Nenna Antonio, Salsano Antonio, Schoell Thibaut, El-Dean Zein, Fiore Antonio, Spadaccio Cristiano
Department of Cardiac Surgery, Centre Cardiologique du Nord, Saint-Denis, France
Department of Cardiac Surgery, Centre Cardiologique du Nord, Saint-Denis, France.
BMJ Open. 2025 May 24;15(5):e101417. doi: 10.1136/bmjopen-2025-101417.
Aortic valve stenosis (AVS) represents the most prevalent primary valvular lesion necessitating surgical intervention or transcatheter intervention in Europe and North America. Its prevalence is increasing at a rapid rate as a consequence of the ageing population. A variety of mechanical interventions are available to determine the management of AVS; however, there is currently a paucity of robust data with which to perform a comparative analysis of the efficacy of surgical aortic valve replacement (SAVR) and that of conventional stented xenograft bioprostheses (BP) or sutureless aortic valves (SAV) and transcatheter aortic valve implantation (TAVI). The present study aims to compare the effectiveness and clinical outcomes of SAVR using BP or SAV technique and TAVI in patients with severe AVS.
A collaboration between three cardiac surgery centres across two European countries has resulted in the conception of the Transcatheter Aortic Valve Implantation vs Surgical Aortic Valve Replacement trial. This prospective non-randomised trial is designed to evaluate the long-term outcomes of TAVI in comparison to SAVR for AVS in patients at risk of severe valve obstruction. The registry will enrol successive patients who have undergone mechanical intervention for AVS between January 2015 and December 2025. Investigators will assess the difference between replacement procedures for both the standard surgical approach and the transcatheter procedure. The principal clinical outcome under consideration will be the composite degree of all-cause mortality, ischaemic stroke or rehospitalisation at 10 years. The present study will also have a number of secondary endpoints, including all-cause mortality, followed by functional status, hospitalisation, neurocognition, physiological measures (echocardiographic assessment), adverse events and reoperation.
It is hypothesised that the nature of the trials will serve to minimise bias related to institutional volume and surgical experience. Each participating centre is required to have an aortic valve programme that enables proper follow-up and management of any late aortic events following replacement surgery for the AVS. The data collected will provide valuable insight into the comparative effectiveness of various surgical approaches, both standardised and advanced, in aortic valve surgery and TAVI. This comprehensive analysis will contribute significantly to the development of robust international guidelines.
Clinical Trial Gov.Com. ID: NCT05261204 IRB. ID: 2022011057.
在欧洲和北美，主动脉瓣狭窄（AVS）是最常见的需要进行外科手术干预或经导管干预的原发性瓣膜病变。由于人口老龄化，其患病率正在迅速上升。有多种机械干预措施可用于确定AVS的治疗方案；然而，目前缺乏有力的数据来对外科主动脉瓣置换术（SAVR）与传统带支架异种生物瓣膜（BP）或无缝合主动脉瓣膜（SAV）以及经导管主动脉瓣植入术（TAVI）的疗效进行比较分析。本研究旨在比较使用BP或SAV技术的SAVR与TAVI在重度AVS患者中的有效性和临床结局。
两个欧洲国家的三个心脏外科中心合作开展了经导管主动脉瓣植入术与外科主动脉瓣置换术试验。这项前瞻性非随机试验旨在评估与SAVR相比，TAVI治疗有严重瓣膜梗阻风险的AVS患者的长期结局。该登记研究将纳入2015年1月至2025年12月期间因AVS接受机械干预的连续患者。研究人员将评估标准手术方法和经导管手术两种置换手术之间的差异。所考虑的主要临床结局将是10年时全因死亡率、缺血性中风或再次住院的综合程度。本研究还将有多个次要终点，包括全因死亡率，随后是功能状态、住院情况、神经认知、生理指标（超声心动图评估）、不良事件和再次手术。
假设该试验的性质将有助于最大限度地减少与机构手术量和手术经验相关的偏差。每个参与中心都需要有一个主动脉瓣项目，以便对AVS置换手术后的任何晚期主动脉事件进行适当的随访和管理。收集的数据将为标准化和先进的各种手术方法在主动脉瓣手术和TAVI中的比较有效性提供有价值的见解。这一全面分析将对制定强有力的国际指南做出重大贡献。
Clinical Trial Gov.Com. ID：NCT05261204 IRB. ID：2022011057。
