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N Engl J Med. 2009 Nov 12;361(20):1953-62. doi: 10.1056/NEJMoa0905368.

Revascularization versus medical therapy for renal-artery stenosis.

Collaborators (475)

Buller N, Flather M, Royston P, Whelton P, Ives N, Kalra PA, Moss JG, Baigent C, Carr S, Chalmers N, Eadington D, Fitzpatrick-Ellis K, Gray R, Hamilton G, Ives N, Kalra PA, Lipkin G, Moss JG, Nicholson A, Scoble J, Wheatley K, Clayton D, Crane D, Dixon A, Kalra PA, Mallick N, Moss JG, Roberts M, Voight J, Wheatley K, Adey E, Daniels J, Fitzpatrick-Ellis K, Gair R, Goodsell S, Handley K, Harding J, Hilken N, Ives N, Jeyaseelan S, Nixon M, Patel L, Patel S, Scott L, Wilks M, Crichton W, Furnace J, Thorpe P, Webster J, Witte K, Harron C, Klenka R, Lipton M, Magennis J, McClelland P, Innes A, MacKenzie P, McKaye I, Brown H, Doherty C, Fogarty D, Hannon R, Johnston G, Johnston L, Loan W, Maxwell P, Carmoody M, Crowe PM, Henderson J, Smith SA, Temple M, Thomas M, Brown E, Frankel A, Greenhalgh RM, McIvor J, Mitchell A, Roddie M, Laing A, McGregor D, Searle M, Usher J, Giles JA, Abbott G, Clements J, Crowe A, Fitzgerald P, Johnson M, King G, McMahon W, Sissons GR, De Nunzio M, Fluck R, McIntyre CW, Cramp H, Douie W, McGonigle RJ, Roobottom CA, Rowe P, Tse W, Wells I, West C, Taylor J, Brammah A, Dreyer J, Hill D, Isles C, Isles K, Robertson S, Watson G, Gibson P, Gillespie I, Goddard J, Ingram S, Whitworth C, Winney R, Ablet M, Brown A, Chaudry T, Christer R, Haslam P, Jackson R, Kanagasundaran S, Loose HW, MacDonald S, Mitchell L, Murthy L, Owen R, Rose J, Tapson JS, Ward MK, Andrews P, Bending M, Bundy K, Eisinger A, Hall JR, Harris F, Hatrick A, Keane A, Keightley A, Kwan J, Marsh JE, Massouh H, North T, Velasco N, Briggs D, Connell JM, Daly C, Dominiczak AF, Edwards R, Geddes C, Gordon A, Gorrie M, Innes J, Jardine A, Junor BJ, MacDonald M, McGregor E, McIntyre M, McLean F, McMillan M, Meredith PA, Morton JJ, Moss JG, Padmanabhan N, Robertson I, Rodger S, Semple P, Baikunje S, Byrne R, Glover R, Kumwenda MJ, McConnell C, Moss E, Deighan C, Ferguson C, Fox J, MacTier R, Roditi G, Simpson K, Banks R, Birch P, Williams A, Bohringer E, Brady L, Roger S, Anodu M, Goldsmith D, Heffernan S, Reidy J, Sacks S, Scoble J, Thomas S, Watkins J, Bedson T, Birch P, Bloodworth L, Godfrey H, Jibani M, Owen J, Phanish MK, Hand M, Millar S, Moreland G, Young J, Bel'Eed K, Cleland J, Dyet J, Eadington D, Ettles D, Farr MJ, Huan Loh P, Lewis D, McCollum PT, Robinson G, Scott P, Sellars L, Glancey G, Picken G, Whitear P, Williams P, Anderson L, Cooke D, Fassett R, Gan JS, Herman B, Mathew MC, Smith M, Barratt J, Blanshard K, Bolia A, Brunskill N, Carr S, Dickinson S, El-Shazly H, Feehally J, Fentum B, Fishwick G, Harris K, James J, Krarup K, Kumar T, Lewington AJ, Medcalfe J, Nicholson S, Rees Y, Thurston H, Topham P, Turner M, Warwick G, Williams B, Farrington K, Fry A, King C, Prendergast C, Warwicker P, Andrew H, Ballardie F, Bendle J, Chalmers N, Comer D, Cruikshank JK, Czapla K, Durrington P, Gokal R, Heagerty A, Hodson P, Howard L, Hutchison A, Malik R, Mallick N, Picton M, Qasim F, Short CD, Smyth JV, Tunbridge D, Wright J, Evans SE, Davies T, Roberts D, Williams A, Chakraverty S, Gourlay N, Henderson I, Houston JG, McDonald T, Struthers AD, Zealley I, Brown CB, Brown P, Brown S, Cleveland T, Davies C, El Nahas A, Euinton H, Ihmoda I, Kuan YC, Moorhead P, Procter A, Thomas S, Throssell D, Cassidy M, Manhire A, Roe SD, Erekosima I, Raja R, Smithard DJ, Arkanath M, Atchley J, Baikunte S, Coni L, Fairley I, Hughes AF, Langham Brown J, Leach TD, Lewis RJ, Mason JC, Stevens JM, Venkat-Ramen G, Adu D, Ball S, Beevers G, Borrows R, Buller N, Cockwell P, Crutch L, Day C, Ferro C, Foggensteiner L, Gray V, Green H, Harper L, Hewins P, Horton K, Ibrahim H, Joy H, Kennedy C, Lipkin G, Little M, Martin U, McCafferty I, McGlynn F, Moniem K, Olliff S, Richards N, Riley P, Savage C, Wheeler D, Buck KS, Daniel T, Ireland H, Jenkins D, Lewis DM, McBride K, Wood SM, Barker LC, Gibson M, King J, Naik RB, Barnes J, Ferris C, Hancock J, Johnston P, Parry R, Smith B, Travis S, D'Souza R, Harrison D, Kinsella D, Watkinson T, Baker D, Cross JM, Davenport A, Goode A, Hamilton G, Kinyanjui R, Myint F, Platts AD, Powis S, Smith S, Sweny P, Tibballs J, Alexander J, Bakran A, Bone JM, Carter PS, Garforth E, McWilliams R, Mohteshamzadeh M, Pai P, Rowlands PC, Rustom R, William P, Burnette L, Irish A, Anderton J, Bailey E, Coward RA, D'Souza S, Gibson SP, MacDowall P, Seriki D, Solomon L, Bradley R, Chalmers A, Fretwell J, Hall C, Hardman J, Hayward S, Horrocks M, John C, Cheung C, Chrysochou T, Cowie A, El'Deen Shurrab A, Gowland S, Green D, Haydock L, Hegarty J, Kalra PA, Mamtora H, Armitage AJ, Burton C, Dudley C, Dudley L, Feest T, Harper S, Haworth J, Lear P, Loveday E, Mathieson P, Mitchell D, Parkin J, Satchell SC, Smith RM, Thornton M, Tomson CR, Belli A, Lawson C, MacGregor G, Swift P, Burwell D, Kessel D, Mooney A, Newstead CG, Nicholson A, Patel J, Akbani H, Barber J, Jeffrey R, Lowe R, Aldridge N, Hewins S, Higgins R, Rush J, Zehnder D, Fleet M, Ackrill P, Ashleigh R, Martin D, Venning M, Slaney P, Spencer S, Bowker A, Jones C, Richardson D, Warnock N, Worth D, Ahmed W, Argarwal S, Drew P, Glover D, Robertson SW, Welham J, Wyn-Jones V.

Abstract

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 micromol 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.)

2009 Massachusetts Medical Society

Comment in

PMID:
19907042
[PubMed - indexed for MEDLINE]
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