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

Journal of Human Hypertension volume 26, pages 507–516 (2012)Cite this article

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.

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Acknowledgements

This study was supported by an unrestricted research grant from The FOundation for advanced Research In Hypertension and CArdiovascular diseases.

Author information

Authors and Affiliations

  1. Department of DMCS—Internal Medicine 4, Padova, Italy

    G P Rossi, T M Seccia, L Calò, M Puato, P Caielli & A C Pessina

  2. Department of Medical-diagnostic Sciences, Institute of Radiology, Padova, Italy

    D Miotto, R Motta, M Vincenzi & G Ramondo

  3. Department of Nuclear Medicine, Padova, Italy

    P Zucchetta & D Cecchin

  4. Department of Internal Medicine, Pisa, Italy

    S Taddei

  5. Department of Internal Medicine, L’Aquila, Italy

    C Ferri

  6. Department of Internal Medicine, Roma, Italy

    C Letizia

  7. Department of Internal Medicine, Bologna, Italy

    C Borghi

  8. Department of Internal Medicine, Milan, Italy

    A Morganti

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  1. G P Rossi
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Consortia

on behalf of the METRAS Investigators

  • Gian Paolo Rossi
  • , Teresa M Seccia
  • , Achille C Pessina
  • , Massimo Puato
  • , Matteo Vincenzi
  • , Maurizio Cesari
  • , Franco Bui
  • , Piero Zucchetta
  • , Diego Cecchin
  • , Paola Caielli
  • , Alberto Morganti
  • , Paolo Dessi
  • , Stefano Taddei
  • , Stefania Pinto
  • , Claudio Ferri
  • , Claudio Letizia
  •  & Anna Belfiore

Corresponding author

Correspondence to G P Rossi.

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The authors declare no conflict of interest.

Additional information

List of participating centers and METRAS study investigators Centers Investigators 1. DMCS Internal Medicine 4, Padova, Italy Gian Paolo Rossi, Teresa M Seccia, Achille C Pessina, Massimo Puato, Matteo Vincenzi, Maurizio Cesari, Franco Bui, Piero Zucchetta, Diego Cecchin, and Paola Caielli 2. Internal Medicine, Milano, Italy Alberto Morganti 3. Endocrinology, Ancona, Italy Paolo Dessi 4. Internal Medicine, Pisa, Italy Stefano Taddei, Stefania Pinto 5. Department of Internal Medicine and Public Health, L’Aquila, Italy Claudio Ferri 6. Internal Medicine, Roma, Italy Claudio Letizia 7. Internal Medicine, Bari, Italy Anna Belfiore

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Rossi, G., Seccia, T., Miotto, D. et al. The Medical and Endovascular Treatment of Atherosclerotic Renal Artery Stenosis (METRAS) study: rationale and study design. J Hum Hypertens 26, 507–516 (2012). https://doi.org/10.1038/jhh.2011.62

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  • DOI: https://doi.org/10.1038/jhh.2011.62

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