Should revascularisation be recommended for atherosclerotic renal artery stenosis?

Abstract

This multicentric, multinational, randomised controlled trial (RCT) was aimed to see if percutaneous revascularisation of the renal arteries in atherosclerotic renovascular disease provided clinical benefits. A total of 806 patients in whom the benefits of revascularisation were thought to be uncertain by their treating physicians were randomised to the medical therapy or the revascularisation plus medical therapy arms. Randomisation was stratified according to serum creatinine levels, Cockcroft-Gault glomerular filtration rate (GFR), severity of renal-artery stenosis, kidney length and rate of progression of renal impairment before entry. The primary outcome was the rate of change of renal function as measured by the reciprocal of the serum creatinine. Blood pressure, time to renal and major cardiovascular events and mortality were additional outcome variables. Of the 403 patients randomised to the revascularisation arm, 335 underwent the procedure; 95% had a stent placed. The technical success was 95%. The crossover rate to revascularisation in the medical therapy group was 6%. Patients were followed up for a median period of 34 months. The rate of change of the slope of the inverse of serum creatinine during follow-up was not different in the two groups (-0.07×10 -3 and -0.13×10-3 l/μmol/year in the revascularisation and medical therapy groups respectively). There was a difference favouring revascularisation of 0.06×10-3 l/μmol/year (95% confidence interval, -0.002-0.13; p=0.06). There was no difference in the change in serum creatinine, systolic blood pressure or rates of renal events, major cardiovascular events and death. The medical therapy group required more antihypertensive agents at one year (2.97 vs 2.77, p=0.03). There were no differences in the outcome in any of the predefined subgroups, including those with high-grade or bilateral stenosis or impaired or decreasing kidney function at entry. Thirty-one patients developed complications within 24 hours of the procedure, and another 55 patients in the next 30 days. These were deemed to be serious in 23 patients, including two deaths and three amputations. The authors concluded that there was no evidence of a worthwhile clinical benefit from revascularisation in patients with atherosclerotic renovascular disease. © 2010 Royal College of Physicians of Edinburgh.