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

Journal of Human Hypertension

Volumn 26, Issue 8, 2012, Pages 507-516

  Rossi, G P ^a   Seccia, T M ^a   Miotto, D ^b   Zucchetta, P ^c   Cecchin, D ^c   Calo L ^a   Puato, M ^a   Motta, R ^b   Caielli, P ^a   Vincenzi, M ^b   Ramondo, G ^b   Taddei, S ^c   Ferri, C ^c   Letizia, C ^c   Borghi, C ^c   Morganti, A ^c   Pessina, A C ^a  

^a UNIVERSITY HOSPITAL OF PADOVA   (Italy)

^b Department of Medical diagnostic Sciences   (Italy)

^c Department of Nuclear Medicine ^*  (Italy)

Author keywords

angioplasty; glomerular filtration rate; renal artery stenosis; revascularization

Indexed keywords

ANGIOTENSIN RECEPTOR ANTAGONIST; CAPTOPRIL; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; PENTETATE TECHNETIUM TC 99M;

ANGIOPLASTY; ANTIHYPERTENSIVE THERAPY; ARTICLE; BLOOD PRESSURE MONITORING; BLOOD PRESSURE REGULATION; GLOMERULUS FILTRATION RATE; HYPERTENSION; KIDNEY ARTERY STENOSIS; KIDNEY FUNCTION; KIDNEY ISCHEMIA; KIDNEY PERFUSION; KIDNEY SCINTISCANNING; PERCUTANEOUS RENAL ANGIOPLASTY AND STENTING; RANDOMIZED CONTROLLED TRIAL (TOPIC); STENT; STUDY DESIGN; TARGET ORGAN;

ANGIOPLASTY, BALLOON; ANTIHYPERTENSIVE AGENTS; ATHEROSCLEROSIS; BIOLOGICAL MARKERS; CARDIOVASCULAR DISEASES; FEMALE; GLOMERULAR FILTRATION RATE; HUMANS; HYPERTENSION, RENOVASCULAR; ITALY; KIDNEY; MALE; PREDICTIVE VALUE OF TESTS; PROSPECTIVE STUDIES; QUALITY OF LIFE; RADIOPHARMACEUTICALS; RENAL ARTERY OBSTRUCTION; RESEARCH DESIGN; STENTS; TECHNETIUM TC 99M PENTETATE; TIME FACTORS; TOMOGRAPHY, X-RAY COMPUTED; TREATMENT OUTCOME; ULTRASONOGRAPHY, DOPPLER;

EID: 84863863998     PISSN: 09509240     EISSN: 14765527     Source Type: Journal    
DOI: 10.1038/jhh.2011.62     Document Type: Article

References (32)

1. Cheung CM, Hegarty J, Kalra PA. Dilemmas in the management of renal artery stenosis. Br Med Bull 2005; 73-74: 35-55. (Pubitemid 43020357)
2. Cheung CM, Wright JR, Shurrab AE, Mamtora H, Foley RN, O'Donoghue DJ et al. Epidemiology of renal dysfunction and patient outcome in atherosclerotic renal artery occlusion. J Am Soc Nephrol 2002; 13: 149-157. (Pubitemid 34042022)
3. Guo H, Kalra PA, Gilbertson DT, Liu J, Chen SC, Collins AJ et al. Atherosclerotic renovascular disease in older US patients starting dialysis, 1996 to 2001. Circulation 2007; 115: 50-58. (Pubitemid 46058611)
4. Bonelli FS, McKusick MA, Textor SC, Kos PB, Stanson AW, Johnson CM et al. Renal artery angioplasty: technical results and clinical outcome in 320 patients. Mayo Clin Proc 1995; 70: 1041-1052.
5. Leertouwer TC, Gussenhoven EJ, Bosch JL, van Jaarsveld BC, van Dijk LC, Deinum J et al. Stent placement for renal arterial stenosis: where do we stand? A meta-analysis. Radiology 2000; 216: 78-85. (Pubitemid 30434724)
6. ASTRAL Investigators Wheatley K, Ives N, Gray R, Kalra PA, Moss JG et al. Revascularization versus medical therapy for renal-artery stenosis. N Engl J Med 2009; 361: 1953-1962.
7. Bax L, Mali WP, Buskens E, Koomans HA, Beutler JJ, Braam B et al. The benefit of STent placement and blood pressure and lipid-lowering for the prevention of progression of renal dysfunction caused by Atherosclerotic ostial stenosis of the Renal artery. The STAR-study: rationale and study design. J Nephrol 2003; 16: 807-812. (Pubitemid 38714223)
8. White CJ. Kiss my astral: one seriously flawed study of renal stenting after another. Catheter Cardiovasc Interv 2010; 75: 305-307.
9. Hirsch AT, Haskal ZJ, Hertzer NR, Bakal CW, Creager MA, Halperin JL et al. ACC/AHA 2005 Practice Guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease): endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease Foundation. Circulation 2006; 113: e463-e654.
10. Webster J, Marshall F, Abdalla M, Dominiczak A, Edwards R, Isles CG et al. Randomised comparison of percutaneous angioplasty vs continued medical therapy for hypertensive patients with atheromatous renal artery stenosis. Scottish and Newcastle Renal Artery Stenosis Collaborative Group. J Hum Hypertens 1998; 12: 329-335. (Pubitemid 28274364)
11. van Jaarsveld BC, Pieterman H, van Dijk LC, van Seijen AJ, Krijnen P, Derkx FH et al. Inter-observer variability in the angiographic assessment of renal artery stenosis. DRASTIC study group. Dutch Renal Artery Stenosis Intervention Cooperative. J Hypertens 1999; 17: 1731-1736.
12. Plouin PF, Chatellier G, Darne B, Raynaud A. Blood pressure outcome of angioplasty in atherosclerotic renal artery stenosis: a randomized trial. Essai Multicentrique Medicaments vs Angioplastie (EMMA) Study Group. Hypertension 1998; 31: 823-829. (Pubitemid 28108582)
13. Radermacher J, Chavan A, Bleck J, Vitzthum A, Stoess B, Gebel MJ et al. Use of Doppler ultrasonography to predict the outcome of therapy for renal-artery stenosis. N Engl J Med 2001; 344: 410-417. (Pubitemid 32128673)
14. Ota H, Takase K, Rikimaru H, Tsuboi M, Yamada T, Sato A et al. Quantitative vascular measurements in arterial occlusive disease. Radiographics 2005; 25: 1141-1158. (Pubitemid 41695335)
15. Sapoval M, Tamari I, Goffette P, Downes M, Senechal Q, Fanelli F et al. One year clinical outcomes of renal artery stenting: the results of ODORI Registry. Cardiovasc Intervent Radiol 2010; 33: 475-483.
16. Rocha-Singh K, Jaff MR, Rosenfield K. Evaluation of the safety and effectiveness of renal artery stenting after unsuccessful balloon angioplasty: the ASPIRE-2 study. J Am Coll Cardiol 2005; 46: 776-783. (Pubitemid 41224798)
17. Rundback JH, Sacks D, Kent KC, Cooper C, Jones D, Murphy T et al. Guidelines for the reporting of renal artery revascularization in clinical trials. American Heart Association. Circulation 2002; 106: 1572-1585.
18. Mancia G, De Backer G, Dominiczak A, Cifkova R, Fagard R, Germano G et al. 2007 Guidelines for the management of arterial hypertension: the task force for the management of arterial hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). Eur Heart J 2007; 28: 1462-1536.
19. Kanjwal K, Cooper CJ, Virmani R, Haller S, Shapiro JI, Burket MW et al. Predictors of embolization during protected renal artery angioplasty and stenting: role of antiplatelet therapy. Cathet Cardiovasc Interv 2010; 76: 16-23.
20. Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med 1999; 130: 461-470. (Pubitemid 29135798)
21. Rossi GP, Sacchetto A, Visentin P, Canali C, Graniero GR, Palatini P et al. Changes in left ventricular anatomy and function in hypertension and primary aldosteronism. Hypertension 1996; 27: 1039-1045. (Pubitemid 26140658)
22. Rossi GP, Cesari M, Sacchetto A. LVH in primary aldosteronism. Hypertension 1997; 30: 1297-1298.
23. Rossi GP, Di Bello V, Ganzaroli C, Sacchetto A, Cesari M, Bertini A et al. Excess aldosterone is associated with alterations of myocardial texture in primary aldosteronism. Hypertension 2002; 40: 23-27. (Pubitemid 34755974)
24. Rizzoni D, Muiesan ML, Salvetti M, Castellano M, Bettoni G, Monteduro C et al. The smoothness index, but not the trough-to-peak ratio predicts changes in carotid artery wall thickness during antihypertensive treatment. J Hypertens 2001; 19: 703-711. (Pubitemid 32289550)
25. Contopoulos-Ioannidis DG, Karvouni A, Kouri I, Ioannidis JP. Reporting and interpretation of SF-36 outcomes in randomised trials: systematic review. BMJ 2009; 338: a3006.
26. D'Agostino Jr RB. Propensity scores in cardiovascular research. Circulation 2007; 115: 2340-2343. (Pubitemid 46685902)
27. Maiolino G, Cesari M, Sticchi D, Zanchetta M, Pedon L, Antezza K et al. Plasma adiponectin for prediction of cardiovascular events and mortality in high-risk patients. J Clin Endocrinol Metab 2008; 93: 3333-3340.
28. Cooper CJ, Murphy TP, Matsumoto A, Steffes M, Cohen DJ, Jaff M et al. Stent revascularization for the prevention of cardiovascular and renal events among patients with renal artery stenosis and systolic hypertension: rationale and design of the CORAL trial. Am Heart J 2006; 152: 59-66. (Pubitemid 43974724)
29. Tobe SW, Atri M, Perkins N, Pugash R, Bell CM. Renal athersosclerotic revascularization evaluation (RAVE study): study protocol of a randomized trial. BMC Nephrol 2007; 8: 4.
30. Povsic TJ, Cohen MG, Mehran R, Buller CE, Bode C, Cornel JH et al. A randomized, partially blinded, multicenter, active-controlled, dose-ranging study assessing the safety, efficacy, and pharmacodynamics of the REG1 anticoagulation system in patients with acute coronary syndromes: design and rationale of the RADAR Phase IIb trial. Am Heart J 2011; 161: 261-268. e1-2.
31. Scarpioni R, Michieletti E, Cristinelli L, Ugolotti U, Scolari F, Venturelli C et al. Atherosclerotic renovascular disease: medical therapy versus medical therapy plus renal artery stenting in preventing renal failure progression: the rationale and study design of a prospective, multicentre and randomized trial (NITER). J Nephrol 2005; 18: 423-428. (Pubitemid 41700106)
32. Kumbhani DJ, Bavry AA, Harvey JE, de Souza R, Scarpioni R, Bhatt DL et al. Clinical outcomes after percutaneous revascularization versus medical management in patients with significant renal artery stenosis; a meta-analysis of randomized controlled trials. Am Heart J 2011; 161: 622-630.