The Medical and Endovascular Treatment of Atherosclerotic Renal Artery Stenosis (METRAS) study: rationale and study design

• Published in: Journal of human hypertension Vol. 26; no. 8; pp. 507 - 516
• Main Authors: Rossi, G P, Seccia, T M, Miotto, D, Zucchetta, P, Cecchin, D, Calò, L, Puato, M, Motta, R, Caielli, P, Vincenzi, M, Ramondo, G, Taddei, S, Ferri, C, Letizia, C, Borghi, C, Morganti, A, Pessina, A C
• Format: Journal Article
• Language: English
• Published: London Nature Publishing Group UK 01-08-2012; Nature Publishing Group
• Subjects: Angioplasty; Angioplasty, Balloon - instrumentation; Antihypertensive agents; Antihypertensive Agents - therapeutic use; Arterial hypertension. Arterial hypotension; Arteriosclerosis; Atherosclerosis; Atherosclerosis - blood; Atherosclerosis - complications; Atherosclerosis - diagnosis; Atherosclerosis - physiopathology; Atherosclerosis - therapy; Biological and medical sciences; Biomarkers - blood; Blood and lymphatic vessels; Blood pressure; Cardiology. Vascular system; Cardiovascular Diseases - etiology; Cardiovascular Diseases - prevention & control; Cardiovascular system; Care and treatment; Complications and side effects; Diagnosis; Epidemiology; Female; Glomerular filtration rate; Glomerular Filtration Rate - drug effects; Health Administration; Health aspects; Humans; Hypertension, Renovascular - blood; Hypertension, Renovascular - diagnosis; Hypertension, Renovascular - etiology; Hypertension, Renovascular - physiopathology; Hypertension, Renovascular - therapy; Ischemia; Italy; Kidney - blood supply; Kidney - drug effects; Kidney - metabolism; Kidney - physiopathology; Kidneys; Male; Medical sciences; Medical treatment; Medicine; Medicine & Public Health; original-article; Patient outcomes; Patients; Pharmacology. Drug treatments; Predictive Value of Tests; Prospective Studies; Public Health; Quality of Life; Radiopharmaceuticals; Renal artery; Renal artery obstruction; Renal Artery Obstruction - blood; Renal Artery Obstruction - diagnosis; Renal Artery Obstruction - etiology; Renal Artery Obstruction - physiopathology; Renal Artery Obstruction - therapy; Renal function; Research Design; Risk factors; Scintigraphy; Stenosis; Stents; Technetium Tc 99m Pentetate; Time Factors; Tomography, X-Ray Computed; Treatment Outcome; Ultrasonography, Doppler; Veins & arteries; Italy; revascularization; renal artery stenosis; glomerular filtration rate; angioplasty; Hypertension; Glomerular filtration; Renal artery; Stenosis; Cardiovascular disease; Endovascular route; Instrumental dilatation; Chemotherapy; Treatment
• ISSN: 0950-9240; 1476-5527
• DOI: 10.1038/jhh.2011.62

It is unclear whether revascularization of renal artery stenosis (RAS) by means of percutaneous renal angioplasty and stenting (PTRAS) is advantageous over optimal medical therapy. Hence, we designed a randomized clinical trial based on an optimized patient selection strategy and hard experimental endpoints. Primary objective of this study is to determine whether PTRAS is superior or equivalent to optimal medical treatment for preserving glomerular filtration rate (GFR) in the ischemic kidney as assessed by 99mTcDTPA sequential renal scintiscan. Secondary objectives of this study are to establish whether the two treatments are equivalent in lowering blood pressure, preserving overall renal function and regressing target organ damage, preventing cardiovascular events and improving quality of life. The study is designed as a prospective multicentre randomized, un-blinded two-arm study. Eligible patients will have clinical and angio–CT evidence of RAS. Inclusion criteria is RAS affecting the main renal artery or its major branches either >70% or, if <70, with post-stenotic dilatation. Renal function will be assessed with 99mTc-DTPA renal scintigraphy. Patients will be randomized to either arms considering both resistance index value in the ischemic kidney and the presence of unilateral/bilateral stenosis. Primary experimental endpoint will be the GFR of the ischemic kidney, assessed as quantitative variable by 99TcDTPA, and the loss of ischemic kidney defined as a categorical variable.