The ASTRAL Trial Demonstrates Angioplasty and Stenting Offer No Benefit Over Medical Therapy in Patients with Renal Arterial Stenoses

April 1, 2008 By Lauren Ciaglo [mailto:lciaglo@perfuse.org]

SCAI-ACCi2 08-Chicago, IL: Results from the ASTRAL trial demonstrate that catheter-based interventions for renal artery stenosis are not associated with improvements in kidney function, blood pressure control, or rates of major cardiovascular illness compared to treatment with medical therapy alone.

Results from randomized, controlled, clinical trials evaluating the efficacy of renal percutaneous revascularization in patients with atherosclerotic renovascular disease (ARVD) have yielded unclear results. Therefore, an adequately powered trial was needed to evaluate the efficacy of catheter-based interventions in the management of ARVD.

The ASTRAL (Angioplasty and Stenting for Renal Artery Lesions) study included 806 renal failure patients (serum creatinine approximately 2 mg/dL) with ARVD who were randomized to receive either catheter-based intervention and medical therapy or medical therapy alone. On an average the % stenosis in the renal artery was 75%.

There was no significant difference in the baseline characteristics between the intervention group and the medical therapy group. The procedure was successful in 88% of patients with a renal artery stenosis <50%. At one year, there was no difference in the change in serum creatinine between the two groups (serum creatinine increased by 0.2 mg/dL in both groups).

At one year follow-up, there was no statistically significant difference in the rates of myocardial infarction, cerebrovascular events, or hospitalization due to angina, heart failure, the need for percutaneous coronary intervention, or bypass surgery between the intervention and medical therapy groups [66% vs. 59%, HR 0.9 (0.66-1.15), p=0.3]. Risk- adjusted mortality was also the same in the two treatment arms [HR 0.92 (0.68-1.26), p=0.6].

ASTRAL is the largest randomized trial to examine outcomes in ARVD. It currently provides the most reliable evidence regarding the role of revascularization in patients with ARVD and how to best treat them.

The investigators concluded that there is “currently no evidence of benefit from catheter-based revascularisation on renal function in the ARVD patients entered into the ASTRAL study”.

Source

 * 1) Late Breaking Clinical Trials Session: SCAI-ACCi2 April 1, 2008 Chicago