Clinical Efficacy and Diagnostic Assessment of Renal Angioplasty in Renal Artery Stenosis: A Systematic Review, Meta-Analysis, and Integrated Clinical Framework

Background: Percutaneous transluminal renal angioplasty (PTRA), with or without stenting, was historically performed to restore renal arterial patency in renal artery stenosis (RAS). Nevertheless, major randomized controlled trials (RCTs) have questioned the routine use of revascularization in renal artery disease. Objective: To conduct a systematic review and quantitative meta-analysis evaluating the clinical effectiveness, physiological predictors, safety, and appropriate indications of percutaneous transluminal renal angioplasty (PTRA), with or without stenting, compared to optimal medical therapy (OMT) in patients with atherosclerotic renal artery stenosis (ARAS) and fibromuscular dysplasia (FMD). Methods: A systematic literature search compliant with PRISMA guidelines was performed in MEDLINE (via PubMed), Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL) for studies published between January 1, 2000, and May 15, 2026. Studies eligible for inclusion were RCTs, prospective cohort studies, and international registries that compared PTRA/stenting with OMT or assessed the diagnostic value of translesional hemodynamic measurements. Two reviewers independently extracted data and evaluated study bias using the Cochrane RoB 2 and ROBINS-I tools. Pooled risk ratios (RRs) and mean differences (MDs) were estimated using a random-effects model. Results: The analysis included 18 studies involving 4,120 patients. Meta-analysis showed no significant benefit of routine revascularization over OMT in unselected ARAS cases regarding composite cardiovascular outcomes (pooled RR: 0.95; 95% CI: 0.81–1.11; p = 0.52) , all-cause mortality, or progression of chronic kidney disease. However, clear clinical advantages were observed in specific high-risk subgroups—particularly those with flash pulmonary edema (Pickering syndrome), persistent hypertension despite treatment with three or more antihypertensive drugs at full dose, or an unexplained drop in eGFR after starting ACE inhibitors or ARBs. In FMD patients, balloon angioplasty alone led to high rates of hypertension resolution or improvement, typically without the need for stent placement. Physiological markers such as translesional pressure gradients (mean ΔP ≥ 10 mmHg or peak ΔP ≥ 20 mmHg), hyperemic fractional flow reserve (FFR ≤ 0.80), and Renal Resistive Index (RRI < 0.70) were strongly associated with positive treatment response. Conclusions: Routine angioplasty or stenting is not recommended for unselected ARAS patients, where optimal medical management remains the preferred approach. PTRA should be considered primarily for FMD and for carefully identified high-risk ARAS cases exhibiting hemodynamically significant stenosis.