Stenting of renal artery stenosis in coronary artery disease (RAS-CAD) study: a prospective, randomized trial

Abstract

Introduction: Atherosclerotic renal artery stenosis (RAS) is associated with premature cardiovascular (CV) events and entails a high mortality risk in patients with coronary artery disease (CAD). The effect of renal revascularization on left ventricular mass is not known.

Aim: The Stenting of Renal Artery Stenosis in Coronary Artery Disease (RAS-CAD) study is a randomized trial designed to study the effect of medical therapy alone versus medical therapy plus renal artery stenting, on left ventricular hypertrophy progression (primary end point), and CV morbidity and mortality (secondary end points), in patients affected by ischemic heart disease and RAS.

Methods: From April 2006 on, all consecutive patients undergoing nonemergent coronary angiography at a single institution are also to be evaluated for RAS by selective renal arteriography. Patients with RAS>50% and <or=80% are randomly assigned to undergo stenting angioplasty plus medical therapy (angioplasty group) or medical therapy alone (drug therapy group) and followed up for 5 years. All randomized patients receive antihypertensive, lipid-lowering or antiplatelet drugs according to current clinical guidelines. The estimated sample size needed to achieve a 80% power to detect as statistically significant a 4 g/m2 difference in left ventricular mass index progression (p<0.01, 2-tailed) between the 2 arms is 168 (84 in the revascularization arm and 84 in the medical management arm).