N Engl J Med. 2014 Jan 2;370(1):13-22. doi: 10.1056/NEJMoa1310753. Epub 2013 Nov 18.

Stenting and medical therapy for atherosclerotic renal-artery stenosis.

Cooper CJ¹, Murphy TP, Cutlip DE, Jamerson K, Henrich W, Reid DM, Cohen DJ, Matsumoto AH, Steffes M, Jaff MR, Prince MR, Lewis EF, Tuttle KR, Shapiro JI, Rundback JH, Massaro JM, D'Agostino RB Sr, Dworkin LD; CORAL Investigators.

Collaborators (297)

Dworkin L, Henrich W, Jamerson K, Cutlip D, Murphy T, Reid D, Steffes M, Jaff M, Matsumoto A, Cohen D, Solomon S, Prince M, D'Agostino R, Tuttle K, Rundback J, Shapiro J, Cooper C, Campese V, Murphy T, Dworkin L, Jamerson K, Cooper C, Henrich W, Cutlip D, Reid D, D'Agostino R, Rundback J, Matsumoto A, Tuttle K, Henrich W, Jamerson K, Greco B, Lopez J, Shepherd A, Weir M, Rundback J, Murphy T, Rosenfield K, Spinosa D, Matsumoto A, Sopko G, Safian R, Cooper C, D'Agostino R, Massaro J, Testa M, Yang S, Campese V, Dworkin L, Henrich W, Cooper C, Cutlip D, Reid D, Dworkin L, Cooper C, Borders N, Shapiro J, Dworkin L, Henrich W, Cooper C, Murphy T, Cutlip D, Flack J, Holper E, Szerlip H, Akpunonu B, Shepherd A, Jamerson K, Rosenfield K, Murphy T, Reid D, Metzger D, Vu D, Textor SC, McKusick M, Abernethy WB, Manley JA, Burket MW, Shapiro JI, Briguglio J, Weiner M, Tuttle KR, Raabe RD, Hirsch AT, Wang Y, Dworkin L, Murphy TP, Tobe S, Pugash R, Schmidt PJ, Sparrow RT, Fenves A, Rees C, Holden A, Doughty R, Pastor J, Reich J, Nanjundappa A, Rahman A, Rapp JH, Sawhney R, Rajagopal V, Frederickson ED, Parker MG, Higgins P, Woittiez A, Kouwenberg HJ, Desire A, Patel A, Matas C, Waisman G, Greco B, Giugliano G, Piegari GN, Modi M, Kanani RS, Scott-Douglas N, White C, Frohlich E, Cannon LA, Willens HJ, Harding M, Gabrys K, Luft FC, Gross M, Ghandour FZ, Gundersen LH, Shepherd A, Suri R, Bacharach M, Zawada E, Rayner B, Ntsekhe M, Thomas WJ, Trivedi AD, McGarvey J, Vernace M, Rossen JD, Lawton WJ, Dauerman H, Solomon R, Cooper M, Deterding J, Carey D, Moffatt L, Kalra PA, Chalmers N, Aronow HD, Rehan A, Razavi MK, Mahon DJ, Effat MA, Yadlapalli G, Edwards MS, Levy P, Redmond K, Mudge D, Ikram S, Ouseph R, Narayanan M, Mixon TA, Rundback JH, Levin D, Bilodeau L, Dominguez M, Anderson R, Smith K, Nseir G, Singh B, Baccaro J, Farias E, Amuchastegui M, Ballarino M, Pietrolungo J, Williams D, Weder A, Leggett J, King P, Exaire J, Haragsim L, Duong M, Gunning ME, Toggart E, Nahm O, Burnes J, Kerr P, Williams ME, Garcia L, Jacobs D, Martin K, Cunningham M, Fang J, Krishnamurthy V, Tremblay A, Bernardo N, Veis JH, Wood D, Levin A, Stouffer GR, Hinderliter A, Marek J, Blum AS, Khera A, Saxena R, Jovin I, Mohanty P, Angle J, Ayers C, Sapoval M, Plouin PF, Nathan S, Mehta R, Contreras G, deMarchena E, Reginelli J, Munson JL, Bashir R, Goldman J, Rajan D, Tobe S, Elmore J, Yahya T, Mulloy L, Kapoor D, Bunch C, Raja F, Banerjee S, Brilakis E, Cronin R, Cross J, Goode A, Parmisano J, Sagastizabal D, Molnar R, Mohammed A, Thomson K, Menahem S, Burchenal J, Dillingham M, Lee J, Chertow G, Flack J, Schreiber TL, Bass T, Vu H, Goldstein J, Katholi RE, Rudnick MR, Topoulus AP, Beres RA, Warren G, Herman TS, Namassivaya A, Lipkin G, McCafferty I, Olin J, Lookstein R, Ritchie J, Wright J, Hiremagalur B, Snow T, Nicholls K, Dowling R, White J, AbuShamat AR, Capers Q, Franco V, Gray B, Oliver TL, Ebrahimi R, Felsenfeld AJ, Weaver FA, Nadim MK, Goldfarb DS, Lorin J, Drooz AT, O'Brien JT, Escandon PJ, Sharma I, Garasic J, Januzzi JL, Tsapatsaris NP, Piemonte T, DeGregorio J, Salazar T, Stuver T, Grieff M, Safian R, Dixon SR, Cospito PD, Vacca WM, Gimelli G, Moncher K, Selby J, Ullian ME, Ali S, Ranval T.

Author information

1: From the University of Toledo, Toledo, OH (C.J.C.); Rhode Island Hospital (T.P.M., L.D.D.) and Alpert Medical School of Brown University (T.P.M., L.D.D.) - both in Providence; Harvard Clinical Research Institute (D.E.C., J.M.M., R.B.D.), Beth Israel Deaconess Medical Center (D.E.C.), Massachusetts General Hospital (M.R.J.), Brigham and Women's Hospital (E.F.L.), and Boston University School of Public Health (R.B.D.) - all in Boston; University of Michigan, Ann Arbor (K.J.); University of Texas Health Science Center, San Antonio (W.H.); National Heart, Lung and Blood Institute, Bethesda, MD (D.M.R.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City School of Medicine, Kansas City (D.J.C.); University of Virginia, Charlottesville (A.H.M.); University of Minnesota, Minneapolis (M.S.); Weill Cornell Medical Center, New York (M.R.P.); Providence Sacred Heart Medical Center and University of Washington School of Medicine, Spokane (K.R.T.); Marshall University, Huntington, WV (J.I.S.); and Holy Name Medical Center, Teaneck NJ (J.H.R.).

Abstract

BACKGROUND:

Atherosclerotic renal-artery stenosis is a common problem in the elderly. Despite two randomized trials that did not show a benefit of renal-artery stenting with respect to kidney function, the usefulness of stenting for the prevention of major adverse renal and cardiovascular events is uncertain.

METHODS:

We randomly assigned 947 participants who had atherosclerotic renal-artery stenosis and either systolic hypertension while taking two or more antihypertensive drugs or chronic kidney disease to medical therapy plus renal-artery stenting or medical therapy alone. Participants were followed for the occurrence of adverse cardiovascular and renal events (a composite end point of death from cardiovascular or renal causes, myocardial infarction, stroke, hospitalization for congestive heart failure, progressive renal insufficiency, or the need for renal-replacement therapy).

RESULTS:

Over a median follow-up period of 43 months (interquartile range, 31 to 55), the rate of the primary composite end point did not differ significantly between participants who underwent stenting in addition to receiving medical therapy and those who received medical therapy alone (35.1% and 35.8%, respectively; hazard ratio with stenting, 0.94; 95% confidence interval [CI], 0.76 to 1.17; P=0.58). There were also no significant differences between the treatment groups in the rates of the individual components of the primary end point or in all-cause mortality. During follow-up, there was a consistent modest difference in systolic blood pressure favoring the stent group (-2.3 mm Hg; 95% CI, -4.4 to -0.2; P=0.03).

CONCLUSIONS:

Renal-artery stenting did not confer a significant benefit with respect to the prevention of clinical events when added to comprehensive, multifactorial medical therapy in people with atherosclerotic renal-artery stenosis and hypertension or chronic kidney disease. (Funded by the National Heart, Lung and Blood Institute and others; ClinicalTrials.gov number, NCT00081731.).