n e w e ng l a n d j o u r na l
m e dic i n e
Revascularization versus Medical Therapy for Renal-Artery Stenosis
The ASTRAL Investigators*
A bs t r ac t
Percutaneous revascularization of the renal arteries improves patency in atherosclerotic renovascular disease, yet evidence of a clinical benefit is limited.
In a randomized,unblinded trial, we assigned 806 patients with atherosclerotic renovascular disease either to undergo revascularization in addition to receiving medical therapy or to receive medical therapy alone. The primary outcome was renal function, as measured by the reciprocal of the serum creatinine level (a measure that has a linear relationship with creatinine clearance). Secondary outcomes were bloodpressure, the time to renal and major cardiovascular events, and mortality. The median follow-up was 34 months.
During a 5-year period, the rate of progression of renal impairment (as shown by the slope of the reciprocal of the serum creatinine level) was −0.07×10−3 liters per micromole per year in the revascularization group, as compared with −0.13×10−3 liters per micromole per year inthe medical-therapy group, a difference favoring revascularization of 0.06×10−3 liters per micromole per year (95% confidence interval [CI], −0.002 to 0.13; P = 0.06). Over the same time, the mean serum creatinine level was 1.6 μmol per liter (95% CI, −8.4 to 5.2 [0.02 mg per deciliter; 95% CI, −0.10 to 0.06]) lower in the revascularization group than in the medical-therapy group. There was nosignificant between-group difference in systolic blood pressure; the decrease in diastolic blood pressure was smaller in the revascularization group than in the medical-therapy group. The two study groups had similar rates of renal events (hazard ratio in the revascularization group, 0.97; 95% CI, 0.67 to 1.40; P = 0.88), major cardiovascular events (hazard ratio, 0.94; 95% CI, 0.75 to 1.19; P =0.61), and death (hazard ratio, 0.90; 95% CI, 0.69 to 1.18; P = 0.46). Serious complications associated with revascularization occurred in 23 patients, including 2 deaths and 3 amputations of toes or limbs.
The members of the writing committee (Keith Wheatley, D.Phil., Natalie Ives, M.Sc., and Richard Gray, M.A., M.Sc., University of Birmingham, Birmingham; Philip A. Kalra, F.R.C.P.,M.D., Salford Royal Hospital, Salford; Jonathan G. Moss, F.R.C.R., F.R.C.S., North Glasgow University Hospitals, Glasgow; Colin Baigent, B.M., B.Ch., Clinical Trial Service Unit, Oxford; Susan Carr, F.R.C.P., M.D., Leicester General Hospital, Leicester; Nicholas Chalmers, F.R.C.R., Manchester Royal Infirmary, Manchester; David Eadington, F.R.C.P., M.D., Hull Royal Infirmary, Hull; George Hamilton,F.R.C.S., M.D., Royal Free Hospital, London; Graham Lipkin, F.R.C.P., M.D., Queen Elizabeth Hospital, Birmingham; Anthony Nicholson, F.R.C.R., Leeds General Infirmary, Leeds; and John Scoble, F.R.C.P., M.D., Guy’s Hospital, London — all in the United Kingdom) assume responsibility for the integrity of the article. Address reprint requests to Ms. Ives at the ASTRAL Trial Office, Birmingham ClinicalTrials Unit, College of Medical and Dental Sciences, Robert Aitken Institute, University of Birmingham, Birmingham B15 2TT, United Kingdom, or at email@example.com. *Investigators in the Angioplasty and Stenting for Renal Artery Lesions (ASTRAL) trial are listed in the Supplementary Appendix, available with the full text of this article at NEJM.org. Dr. Wheatley, Ms. Ives, Dr. Kalra, and Dr.Moss contributed equally to this article. N Engl J Med 2009;361:1953-62.
Copyright © 2009 Massachusetts Medical Society.
We found substantial risks but no evidence of a worthwhile clinical benefit from revascularization in patients with atherosclerotic renovascular disease. (Current Controlled Trials number, ISRCTN59586944.)
n engl j med 361;20
november 12, 2009