1. The Medical and Endovascular Treatment of Atherosclerotic Renal Artery Stenosis (METRAS) study: rationale and study design.
- Author
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Rossi GP, Seccia TM, 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, and Pessina AC
- Subjects
- Atherosclerosis blood, Atherosclerosis complications, Atherosclerosis diagnosis, Atherosclerosis physiopathology, Biomarkers blood, Cardiovascular Diseases etiology, Cardiovascular Diseases prevention & control, Female, Glomerular Filtration Rate drug effects, Humans, Hypertension, Renovascular blood, Hypertension, Renovascular diagnosis, Hypertension, Renovascular etiology, Hypertension, Renovascular physiopathology, Italy, Kidney metabolism, Kidney physiopathology, Male, Predictive Value of Tests, Prospective Studies, Quality of Life, Radiopharmaceuticals, Renal Artery Obstruction blood, Renal Artery Obstruction diagnosis, Renal Artery Obstruction etiology, Renal Artery Obstruction physiopathology, Stents, Technetium Tc 99m Pentetate, Time Factors, Tomography, X-Ray Computed, Treatment Outcome, Ultrasonography, Doppler, Angioplasty, Balloon instrumentation, Antihypertensive Agents therapeutic use, Atherosclerosis therapy, Hypertension, Renovascular therapy, Kidney blood supply, Kidney drug effects, Renal Artery Obstruction therapy, Research Design
- Abstract
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.
- Published
- 2012
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