BLOOD-PRESSURE OUTCOME OF ANGIOPLASTY IN ATHEROSCLEROTIC RENAL-ARTERYSTENOSIS - A RANDOMIZED TRIAL

Data for the effects on blood pressure of renal artery balloon angiopl asty are mostly from uncontrolled studies. The aim of this study was t o document the efficacy and safety oi angioplasty for lowering blood p ressure in patients with atherosclerotic renal artery stenosis. Patien ts were randomly assigned antihypertensive drug treatment (control gro up, n = 26) or angioplasty (n = 23). Twenty-four-hour ambulatory blood pressure, the primary end point, was measured at baseline and at term ination. Termination took place 6 months after randomization or earlie r in patients who developed refractory hypertension. In those allocate d angioplasty, antihypertensive treatment was discontinued after dir p rocedure but was subsequently resumed if hypertension persisted. Secon dary end points were the treatment score and the incidence of complica tions. Two patients in the control group and 6 in the angioplasty grou p suffered procedural complications (relative risk, 3.4; 95% confidenc e interval, 0.8 to 15.1). Early termination was required for refractor y hypertension in 7 patients in the control group. Antihypertensive tr eatment was resumed in 17 patients in the angioplasty group. Mean ambu latory blood pressure at termination did not differ between control (1 41 +/- 15/84 +/- 11 mm Hg) and angioplasty (140 +/- 15/81 +/- 9 mm Hg) groups. Angioplasty reduced by 60% the probability of having a treatm ent score of 2 or more at termination (relative risk, 0.4; 95% confide nce interval, 0.2 to 0.7). There was 1 case of dissection with segment al renal infarction and 3 of restenosis in the angioplasty group. No p atient suffered renal artery thrombosis. In unilateral atherosclerotic renal artery stenosis, angioplasty is a drug-sparing procedure that i nvolves some morbidity. Previous uncontrolled and unblinded assessment s of angioplasty overestimated its potential for lowering blood pressu re.