Renal artery angioplasty and stenting remain controversial in managing atherosclerotic renal artery stenosis. Landmark trials (ASTRAL and CORAL) failed to show superiority over optimal medical therapy, yet design limitations, including the exclusion of high-risk patients, the employment of variable imaging modalities, and the utilisation of non-standardised protocols, undermined both studies and limited their applicability. Since these trials, the RADAR trial was prematurely terminated, echoing prior findings, but in a small cohort of patients. Of six major RCTs since 1998, most excluded patients with flash pulmonary oedema, refractory hypertension, or rapidly declining renal function. Meta-analyses report reduced antihypertensive burden after renal artery revascularisation, particularly in those with severe or resistant hypertension, but without clear benefit for mortality, renal function, or adverse events. Lower-level evidence from case series highlights success in select high-risk situations (recurrent pulmonary oedema, progressive renal decline, or complex anatomy). Current American College of Cardiology Foundation (ACCF)/American Heart Association (AHA) and European Society of Cardiology (ESC) guidelines endorse revascularisation in specific contexts (Level B–C evidence). Given the limitations of past RCTs, there is a need for robust new RCTs in appropriate patient populations to conclusively determine the role of renal angioplasty and stenting in atherosclerotic renal artery stenosis. Key Points 1. Both the ASTRAL and CORAL RCTs excluded high-risk patient cohorts (flash pulmonary oedema, refractory hypertension, rapidly declining renal function), underrepresented patients with severe renal artery stenosis (RAS), relied on variable imaging modalities for RAS diagnosis, and lacked procedural consistency, reducing broad applicability in real-world clinical practice. 2. Despite being a relatively common condition, the role of RAS revascularisation remains highly debated. High-risk subgroups remain underrepresented in the current evidence base, with limited low-level recommendations for offering treatment from the American College of Cardiology Foundation (ACCF)/American Heart Association (AHA) and the European Society of Cardiology (ESC) guidelines (Level B–C). 3. A robustly powered, multicentre RCT targeting severe RAS (>70% stenosis, ideally confirmed by pressure gradients and with core lab adjudication) and including patients who are high-risk with flash pulmonary oedema and rapid decline in renal function, is important to definitively assess the clinical benefit of angioplasty and stenting in RAS.
Dempsey et al. (Thu,) studied this question.