From the Hypertension Department (P.-F.P.), Department of Medical
Informatics (G.C., B.D.), and Department of Cardiovascular Radiology (A.R.),
Hôpital Broussais, and INSERM U-36 (P.-F.P.), Paris, France.
Correspondence to Prof P.F. Plouin, Hôpital Broussais, 96 rue Didot, 75674 Paris Cedex 14, France. E-mail plouin{at}hbroussais.fr
Abstract—Data for the effects on
blood pressure of renal artery balloon angioplasty are mostly from
uncontrolled studies. The aim of this study was to document the
efficacy and safety of angioplasty for lowering blood pressure in
patients with atherosclerotic renal artery stenosis. Patients
were randomly assigned antihypertensive drug treatment (control group,
n=26) or angioplasty (n=23). Twenty-four-hour ambulatory blood
pressure, the primary end point, was measured at baseline and at
termination. Termination took place 6 months after randomization or
earlier in patients who developed refractory hypertension. In those
allocated angioplasty, antihypertensive treatment was discontinued
after the procedure but was subsequently resumed if hypertension
persisted. Secondary end points were the treatment score and the
incidence of complications. Two patients in the control group and 6 in
the angioplasty group suffered procedural complications (relative risk,
3.4; 95% confidence interval, 0.8 to 15.1). Early termination was
required for refractory hypertension in 7 patients in the control
group. Antihypertensive treatment was resumed in 17 patients in the
angioplasty group. Mean ambulatory blood pressure at termination did
not differ between control (141±15/84±11 mm Hg) and angioplasty
(140±15/81±9 mm Hg) groups. Angioplasty reduced by 60% the
probability of having a treatment score of 2 or more at termination
(relative risk, 0.4; 95% confidence interval, 0.2 to 0.7). There was 1
case of dissection with segmental renal infarction and 3 of
restenosis in the angioplasty group. No patient suffered renal
artery thrombosis. In unilateral atherosclerotic renal artery
stenosis, angioplasty is a drug-sparing procedure that involves
some morbidity. Previous uncontrolled and unblinded assessments of
angioplasty overestimated its potential for lowering blood
pressure.
© 1998 American Heart Association, Inc.
Scientific Contributions
Blood Pressure Outcome of Angioplasty in Atherosclerotic Renal Artery Stenosis
A Randomized Trial
Key Words: renal artery obstruction • atherosclerosis • randomized controlled trials • angioplasty, balloon
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