Revascularization offers little or no “worthwhile clinical benefit” over medical treatment for patients with renal artery stenosis, regardless of the extent of their renal disease, researchers concluded.
The findings are based on data from the Angioplasty and Stenting for Renal Artery Lesions (ASTRAL) trial, a British study in which investigators randomized 806 patients with atherosclerotic renovascular disease to undergo revascularization (angioplasty either alone or with stenting) plus medical therapy or medical therapy alone (statins, antiplatelet agents, and optimal BP control).
The primary outcome was the change in renal function as measured by the reciprocal of the serum creatinine level, which has a linear relationship with creatinine clearance (a surrogate for glomerular filtration rate).
Over a period of five years, the rate of progression of renal impairment—as indicated by the slope of the reciprocal of the serum creatinine level—and the mean serum creatinine level did not differ significantly between the two groups, according to a report in The New England Journal of Medicine (2009;361:1953-1962).
In addition, the two study arms had similar rates of renal events, major cardiovascular events, and deaths. Systolic BP did not differ significantly between the two groups, but the decrease in diastolic BP was significantly greater in the medical-therapy group. There was also no difference in the primary outcome between patients with severe renal-artery disease (bilateral stenosis of more than 70% or stenosis of more than 70% in a single functioning kidney) and those without such severe disease, the investigators noted.
Serious complications associated with revascularization occurred in 23 patients, including two deaths and three limb or toe amputations, the researchers stated.
“We found no evidence of a worthwhile clinical benefit in the initial years after revascularization in patients with atherosclerotic renal-artery stenosis,” the authors wrote.