Daniel G. Hackam, MD, PhD; Amit X. Garg, MD, PhD
In patients with renal artery stenosis, does adding revascularization to medical therapy improve renal function?
Randomized controlled trial (RCT) (Angioplasty and Stenting for Renal Artery Lesions [ASTRAL] trial). ISRCTN59586944.
≤ 5 years (median 33.6 mo).
57 hospitals in the UK, Australia, and New Zealand.
806 patients (mean age 71 y, 63% men, mean renal arterial stenosis 76%) with substantial anatomical atherosclerotic stenosis in ≥ 1 renal artery that was potentially suitable for endovascular revascularization and whose doctors were uncertain that the patients would definitely benefit from revascularization. Exclusion criteria were definite need for surgical revascularization or high likelihood of need for revascularization within 6 months, nonatheromatous cardiovascular (CV) disease, or previous revascularization for renal artery stenosis.
Medical therapy plus revascularization by angioplasty (alone or with stenting) without renal protection devices (n = 403) or medical therapy alone in accordance with local protocols (n = 403).
Change in renal function (mean slope of reciprocal of serum creatinine level over time). Secondary outcomes included renal events (new onset of acute kidney injury, dialysis initiation, renal transplantation, nephrectomy, and death from renal failure), major CV events (myocardial infarction, stroke, CV death, hospitalization for angina, fluid overload or cardiac failure, coronary artery revascularization, and other peripheral arterial procedures), and mortality. 700 patients were needed to detect a 20% difference between groups in renal function (80% power, 2-tailed P < 0.05).
95% (intention-to-treat analysis).
Revascularization and medical therapy did not differ for change in renal function (mean slope −0.07 × 10−3 vs −0.13 × 10−3 L/µmol/y, P = 0.06), renal events, major CV events, or mortality (Table).
Adding revascularization to medical therapy did not improve renal function or reduce mortality, renal events, or major cardiovascular events in atherosclerotic renal artery stenosis.
Revascularization plus medical therapy (RMT) vs medical therapy (MT) alone for renal artery stenosis†
†NS = not significant; other abbreviations defined in Glossary. Data were calculated using Kaplan-Meier analysis. RRR, NNT, and CI calculated from control event rates and hazard ratios in article.
‡New onset of acute kidney injury, dialysis initiation, renal transplantation, nephrectomy, and death from renal failure.
§Myocardial infarction; stroke; cardiovascular death; hospitalization for angina, fluid overload, or cardiac failure; coronary artery revascularization; and other peripheral arterial procedures.
Hackam DG, Garg AX. Adding revascularization to medical therapy did not improve renal function in atherosclerotic renal artery stenosis. Ann Intern Med. ;152:JC2–6. doi: 10.7326/0003-4819-152-4-201002160-02006
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Published: Ann Intern Med. 2010;152(4):JC2-6.
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