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Background Percutaneous revascularization of the renal arteries improves patency in atherosclerotic renovascular disease, yet evidence of a clinical benefit is limited.
Methods 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 blood pressure, the time to renal and major cardiovascular events, and mortality. The median follow-up was 34 months.
Results 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 –0.07x10–3 liters per micromole per year in the revascularization group, as compared with –0.13x10–3 liters per micromole per year in the medical-therapy group, a difference favoring revascularization of 0.06x10–3 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 no significant 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.
Conclusions 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
[controlled-trials.com]
.)
Source Information
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.
Dr. Wheatley, Ms. Ives, Dr. Kalra, and Dr. Moss contributed equally to this article.
Address reprint requests to Ms. Ives at the ASTRAL Trial Office, Birmingham Clinical Trials Unit, College of Medical and Dental Sciences, Robert Aitken Institute, University of Birmingham, Birmingham B15 2TT, United Kingdom, or at n.j.ives{at}bham.ac.uk.
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