Department of Cardiology (QEHB), University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK
Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, UK.
BMJ Open. 2024 Jun 10;14(6):e086587. doi: 10.1136/bmjopen-2024-086587.
Aortic stenosis (AS) is common affecting >13% of adults over the age of 75 years. In people who develop symptoms, without valve replacement, prognosis is dismal with mortality as high as 50% at 1 year. In asymptomatic patients, the timing of valve intervention is less well defined and a strategy of watchful waiting is recommended. Many, however, may develop symptoms and attribute this to age related decline, rather than worsening AS. Timely intervention in asymptomatic severe AS is critical, since delayed intervention often results in poor outcomes. Proactive surveillance of symptoms, quality of life and functional capacity should enable timely identification of people who will benefit from aortic valve replacement. There are no data however, to support the clinical and cost effectiveness of such an approach in a healthcare setting in the UK. The aim of this pilot trial is to test the feasibility of a full-scale randomised controlled trial (RCT) to determine the utility of proactive surveillance in people with asymptomatic severe AS to guide the timing of intervention.
APRAISE-AS is a multi-centre, non-blinded, two-arm, parallel group randomised controlled trial of up to 66 participants aged >18 years with asymptomatic severe AS. Participants will be randomised to either standard care or standard care supplemented with the APRAISE-AS intervention. Primary outcomes will capture; adherence to and participant acceptability of the intervention, recruitment and retention rates, and completeness of data collection. The findings will be used to inform the sample size and most appropriate outcome measure(s) for a full-scale RCT and health economic evaluation.
Ethical approval was granted by the Black Country REC, reference: 22/WM/0214. Results will be submitted for publication in peer-reviewed journals and disseminated at local, regional and national meetings where appropriate.
ISRCTN19413194 registered on 14.07.2023.
主动脉瓣狭窄（AS）在 75 岁以上的成年人中较为常见，患病率超过 13%。在出现症状而未行瓣膜置换的患者中，如果不进行治疗，其 1 年死亡率高达 50%。在无症状患者中，瓣膜干预的时机尚未明确，推荐采取观察等待策略。然而，许多患者可能会出现症状，并将其归因于与年龄相关的衰退，而非 AS 恶化。对于无症状重度 AS 患者，及时进行干预至关重要，因为延迟干预通常会导致不良结局。对症状、生活质量和功能能力进行积极监测，有助于及时发现需要行主动脉瓣置换的患者。但是，目前在英国的医疗环境中，尚无数据支持这种方法在临床和成本效益方面的有效性。本试验旨在检验一项大型随机对照试验（RCT）的可行性，以评估主动监测在无症状重度 AS 患者中的作用，从而指导干预时机。
APRAISE-AS 是一项多中心、非盲、两臂、平行组 RCT，纳入年龄＞18 岁的无症状重度 AS 患者，最多 66 例。患者将被随机分配至标准治疗组或标准治疗+APRAISE-AS 干预组。主要结局将评估：干预措施的依从性和患者可接受性、入组率和保留率，以及数据采集的完整性。研究结果将用于为大型 RCT 和卫生经济学评价提供样本量和最合适的结局指标。
本研究已获得黑乡地区研究伦理委员会的批准，注册号：22/WM/0214。研究结果将提交至同行评议期刊发表，并在当地、区域和全国会议上进行适当推广。
ISRCTN80216372，于 2023 年 7 月 14 日注册。
