Perception and acceptability of open versus endovascular treatment of common femoral artery disease: barriers and facilitators for randomised controlled trials

Abstract

Introduction: The common femoral artery (CFA) is often affected by atherosclerosis in patients with peripheral arterial disease, requiring revascularisation. Open surgical CFA endarterectomy (CFAE) remains the standard of care in this context; however, there have been multiple recent advances in endovascular CFA therapies. However, randomised controlled trials (RCTs) comparing CFA treatments have suffered from multiple pitfalls. This research aimed to assess opinions regarding potential barriers and enablers of delivering a high-quality RCT of open surgical CFAE versus endovascular CFA therapy. Methods: A mixed-methods qualitative study was performed, including a structured online survey and face-to-face semi-structured interviews with healthcare professionals. Survey content and interview topic guides were developed following a literature review to identify ongoing and completed RCTs comparing CFA treatments. The data were analysed using thematic analysis. Results: The online survey was completed by 121 participants, including vascular surgeons (n=75, 62%) and interventional radiologists (n=22, 18%), mostly from the UK (n=92, 76%). A total of 61 participants (51%) would be willing to take part in an RCT comparing open versus endovascular CFA revascularisation. The majority (n=89, 74%) believed that such an RCT is urgently needed. Fifteen participants were interviewed face-to-face. Five main themes emerged regarding barriers and facilitators for a high-quality RCT in this context: factors directly limiting patient recruitment; clinicians’ attitudes towards equipoise between treatments; clinicians’ attitudes towards endovascular therapies; attitudes towards outcomes examined in a potential RCT; and factors facilitating patient recruitment. From these, 10 sub-themes were identified. Conclusion: The majority of survey respondents believed an RCT comparing open and endovascular CFA revascularisation is necessary and would participate in such a trial. Important barriers and enablers, grouped in five overarching themes, have been identified, which would require serious consideration when designing and delivering such an RCT.