Arterial stenting and balloon angioplasty in ostial atherosclerotic renovascular disease: a randomised trial

Background Percutaneous transluminal angioplasty (PTB) for ostial atheroscl erotic renal-artery stenosis has poor results. Angioplasty with stent place ment (PTAS) may be more effective, We undertook a randomised prospective st udy to compare PTA with PTAS in patients with ostial atherosclerotic renal- artery stenosis, Methods Patients with ostial atherosclerotic renal-artery stenosis were ass igned to receive PTA or PTAS, Secondary PTAS was allowed if PTA failed imme diately or during 6 months' follow-up, Analysis was by intention to treat, Findings 42 patients were assigned PTB and 43 were assigned PTAS, but. one patient in the PTAS group was excluded from the study. Primary success rate (<50% residual stenosis) of PTA was 57% (24 patients) compared with 88% (3 7 patients) for PTAS (difference between groups 31% [95% CI 12-50]), Compli cations were similar, At 6 months, the primary patency rate was 29% (12 pat ients) for PTA, and 75% (30 patients) for PTAS (46% [24-68]), Restenosis af ter a successful primary procedure occurred in 48% of patients for PTA and 14% for PTAS (34% [11-58]), 12 patients underwent secondary stenting for pr imary or late failure of PTB within the follow-up period: success was simil ar to that of primary PTAS, Evaluation based on intention to treat showed n o difference in clinical results at six months for PTB or PTAS, Interpretation PTAS is a better technique than PTA to achieve vessel patenc y in ostial atherosclerotic renal-artery stenosis, Primary PTAS and primary PTA plus PTAS as rescue therapy have similar outcomes, However, the burden of reintervention after PTA outweighs the potential saving in stents, so p rimary PTAS is a better approach to use.