title: The Medical and Endovascular Treatment of Atherosclerotic Renal Artery Stenosis (METRAS) study: rationale and study 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.
authors.affiliation: Department of DMCS-Internal Medicine 4, Padova, Italy. gianpaolo.rossi@unipd.it
authors.forename: G P
authors.initials: GP
authors.lastname: Rossi
authors.forename: T M
authors.initials: TM
authors.lastname: Seccia
authors.forename: D
authors.initials: D
authors.lastname: Miotto
authors.forename: P
authors.initials: P
authors.lastname: Zucchetta
authors.forename: D
authors.initials: D
authors.lastname: Cecchin
authors.forename: L
authors.initials: L
authors.lastname: Calò
authors.forename: M
authors.initials: M
authors.lastname: Puato
authors.forename: R
authors.initials: R
authors.lastname: Motta
authors.forename: P
authors.initials: P
authors.lastname: Caielli
authors.forename: M
authors.initials: M
authors.lastname: Vincenzi
authors.forename: G
authors.initials: G
authors.lastname: Ramondo
authors.forename: S
authors.initials: S
authors.lastname: Taddei
authors.forename: C
authors.initials: C
authors.lastname: Ferri
authors.forename: C
authors.initials: C
authors.lastname: Letizia
authors.forename: C
authors.initials: C
authors.lastname: Borghi
authors.forename: A
authors.initials: A
authors.lastname: Morganti
authors.forename: A C
authors.initials: AC
authors.lastname: Pessina
mesh_terms: D000800:Angioplasty, Balloon / Q000295:instrumentation; D000959:Antihypertensive Agents / Q000627:therapeutic use*; D050197:Atherosclerosis / Q000097:blood / Q000150:complications / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D015415:Biomarkers / Q000097:blood; D002318:Cardiovascular Diseases / Q000209:etiology / Q000517:prevention & control; D005260:Female; D005919:Glomerular Filtration Rate / Q000187:drug effects; D006801:Humans; D006978:Hypertension, Renovascular / Q000097:blood / Q000175:diagnosis / Q000209:etiology / Q000503:physiopathology / Q000628:therapy*; D007558:Italy; D007668:Kidney / Q000098:blood supply* / Q000187:drug effects* / Q000378:metabolism / Q000503:physiopathology; D008297:Male; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011788:Quality of Life; D019275:Radiopharmaceuticals; D012078:Renal Artery Obstruction / Q000097:blood / Q000175:diagnosis / Q000209:etiology / Q000503:physiopathology / Q000628:therapy*; D012107:Research Design; D015607:Stents; D016284:Technetium Tc 99m Pentetate; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D018608:Ultrasonography, Doppler
chemical_list: D000959:Antihypertensive Agents; D015415:Biomarkers; D019275:Radiopharmaceuticals; D016284:Technetium Tc 99m Pentetate