腎動脈ステントは臨床的な有益性を示さなかった （LBCT 4/Abstract: 19514）

CORAL：腎動脈狭窄においてステント挿入は薬物療法と比較し有意な有益性を示さなかった　
CORAL: Stenting showed no significant benefit compared to medication in renal artery stenosis
患者にとって腎動脈狭窄の解除は内服治療単独よりも役立つことはなかったとのlate-breaking clinical trialの結果が2013年American Heart Association学会で発表され、同時にNew England Journal of Medicine（NEJM） に掲載された。Cardiovascular Outcomes in Renal Atherosclerotic Lesions（CORAL）において、慢性腎臓病または高血圧で腎動脈狭窄を有する患者947人が血圧、コレステロールおよび抗凝固に関する標準的な薬物併用療法、またはこれらの薬物療法に加え腎動脈ステントを施行する群に無作為に割り付けられた。死亡率および他の重篤な合併症（心筋梗塞、脳卒中、または心疾患および腎疾患による入院）発現率は、治療群間で差がなかった。合併症発現率は薬物療法のみの群で35.8%、併用療法群で35.1%であり、有意差はなかった。フォローアップ期間中の収縮期血圧は一貫してステント群の方がやや良好であった（P =0.03）。スタディに参加したNEJMの編集委員は、中等度の動脈硬化性腎動脈疾患を有し高血圧またはステージ3の慢性腎臓病を有する患者は降圧剤による血圧コントロールを受け動脈硬化の進行を予防すべきであり、腎動脈ステント術は施行されるべきではないと勧告している。
Full Text

Opening narrowed renal arteries didn't help patients any more than taking medicine alone, according to a late-breaking clinical trial presented at the American Heart Association's Scientific Sessions 2013 and simultaneously published in the New England Journal of Medicine (NEJM).

In the Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL) trial, 947 patients with renal artery stenosis, in the setting of chronic kidney diseases or hypertension were randomly assigned to receive standard combination medical therapy for blood pressure, cholesterol and anticoagulation alone, or these medications combined with renal artery stenting.

The rate of death and other serious complications, including myocardial infarction, stroke, or hospitalization for heart or kidney disease, was comparable between treatment methods. Complications occurred in 35.8 percent of the medication-only group, and in 35.1 percent of the combined-treatment group, not a significant difference.

During follow-up, there was a consistent modest difference in systolic blood pressure favoring the stent group (P =0.03)

Atherosclerotic renal-artery stenosis is a common problem in the elderly.  It often occurs in combination with peripheral arterial or coronary artery disease.  Standard treatment includes medication to decrease high blood pressure and cholesterol, combined with renal artery stenting.  Despite earlier clinical trials, the usefulness of stenting for the prevention of major adverse renal and cardiovascular events is uncertain.

"Stenting of atherosclerotic renal stenosis has been reasonable, despite several negative studies, because other studies suggested it might lower blood pressure and stabilize kidney function," said Christopher J. Cooper, M.D., the study's lead author and professor and chairman of the Department of Medicine at the University of Toledo, Ohio. "But in our study, opening narrowed kidney arteries with stents provided no additional benefit when added to medications that lower blood pressure, control cholesterol levels and block substances involved in blood clotting."

In an editorial in NEJM that accompanied the study, Dr. John A. Bittle of Munroe Regional Medical Center in Ocala, Florida, recommended that patients with moderately severe atherosclerotic renovascular disease and either hypertension or stage 3 chronic kidney disease should receive medical therapy to control blood pressure and prevent the progression of atherosclerosis but should not receive a renal-artery stent.

Co-authors are Timothy P. Murphy, M.D.; Donald E. Cutlip, M.D.; Kenneth Jamerson, M.D.; William Henrich, M.D.; Diane M. Reid; David J. Cohen, M.D., M.Sc.; Alan H. Matsumoto, M.D.; Michael Steffes, M.D.; Michael R. Jaff, D.O., M.D.; Martin R. Prince, M.D., Ph.D.; Eldrin F. Lewis, M.D.; Katherine R. Tuttle, M.D.; Joseph I. Shapiro, M.D., M.P.H.; John H. Rundback, M.D.; Joseph M. Massaro, Ph.D.; Ralph B. D'Agostino, Sr., Ph.D. and Lance D. Dworkin, M.D.,

The National Heart, Lung, and Blood Institute, National Institutes of Health, funded the study.