Aortic stenosis (AS), a condition impacting over 13% of adults above 75, poses significant mortality risks if left untreated. While symptomatic patients often receive valve replacements, the trajectory for asymptomatic individuals remains less clear, leading to a strategy of watchful waiting. Recognizing symptoms early is crucial, as many patients may mistakenly attribute them to aging rather than the progression of AS, resulting in delayed interventions and poorer outcomes.
Study Design and Objectives
The APRAISE-AS trial aims to evaluate the feasibility of proactive surveillance in individuals with asymptomatic severe AS. This multi-centre, non-blinded, two-arm, parallel group randomized controlled trial will involve up to 66 participants aged over 18 years. Participants will be divided into two groups: one receiving standard care alone, and the other receiving standard care supplemented with the APRAISE-AS intervention. The primary focus will be on adherence, participant acceptance, recruitment and retention rates, and data collection completeness.
Expected Outcomes and Measures
The primary outcomes of the study will inform on the feasibility of a full-scale RCT, including the most appropriate outcome measures and sample size. The trial also aims to evaluate the clinical and cost-effectiveness of proactive surveillance in a UK healthcare setting. Ethical approval for the trial has been granted by the Black Country REC, and results will be disseminated through various channels including peer-reviewed journals and relevant meetings.
User-Usable Inferences
- Regular monitoring of quality of life and functional capacity in asymptomatic severe AS patients can lead to timely interventions.
- Proactive surveillance may help differentiate age-related symptoms from those due to worsening AS.
- Adherence and participant acceptability are critical factors in the success of proactive surveillance strategies.
The APRAISE-AS trial represents a significant step towards understanding the benefits of proactive surveillance in asymptomatic severe AS. Its findings will guide future large-scale studies and potentially influence clinical practice concerning the timing of interventions for these patients.
Original Article: BMJ Open. 2024 Jun 10;14(6):e086587. doi: 10.1136/bmjopen-2024-086587.
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