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Stent Placement in Patients With Atherosclerotic Renal Artery Stenosis and Impaired Renal Function
A Randomized Trial
- Liesbeth Bax, MD, PhD;
- Arend-Jan J. Woittiez, MD, PhD;
- Hans J. Kouwenberg, MD;
- Willem P.T.M. Mali, MD, PhD;
- Erik Buskens, MD, PhD;
- Frederik J.A. Beek, MD, PhD;
- Branko Braam, MD, PhD;
- Frans T.M. Huysmans, MD, PhD;
- Leo J. Schultze Kool, MD, PhD;
- Matthieu J.C.M. Rutten, MD;
- Cornelius J. Doorenbos, MD, PhD;
- Johannes C.N.M. Aarts, MD;
- Ton J. Rabelink, MD, PhD;
- Pierre-François Plouin, MD;
- Alain Raynaud, MD;
- Gert A. van Montfrans, MD, PhD;
- Jim A. Reekers, MD, PhD;
- Anton H. van den Meiracker, MD, PhD;
- Peter M.T. Pattynama, MD, PhD;
- Peter J.G. van de Ven, MD, PhD;
- Dammis Vroegindeweij, MD, PhD;
- Abraham A. Kroon, MD, PhD;
- Michiel W. de Haan, MD, PhD;
- Cornelis T. Postma, MD, PhD; and
- Jaap J. Beutler, MD, PhD*
- From University Medical Center Utrecht and Julius Center for Health Sciences and Primary Care, Utrecht, Twenteborg Hospital Almelo, Almelo, University Medical Center Groningen, Groningen, University Medical Center Nijmegen, Nijmegen, Jeroen Bosch Hospital, 's-Hertogenbosch, Deventer Hospital, Deventer, University Medical Center Leiden, Leiden, Academic Medical Center Amsterdam, Amsterdam, Erasmus Medical Center Rotterdam and Maasstad Hospital, Rotterdam, and University Hospital Maastricht, Maastricht, the Netherlands; University of Alberta Hospital, Edmonton, Alberta, Canada; and European Hospital Georges Pompidou, Paris, France.
Abstract
Background: Little is known about the efficacy and safety of renal artery stenting in patients with atherosclerotic renal artery stenosis (ARAS) and impaired renal function.
Objective: To determine the efficacy and safety of stent placement in patients with ARAS and impaired renal function.
Design: Randomized clinical trial. Randomization was centralized and computer generated, and allocation was assigned by e-mail. Patients, providers, and persons who assessed outcomes were not blinded to treatment assignment.
Setting: 10 European medical centers.
Participants: 140 patients with creatinine clearance less than 80 mL/min per 1.73 m2 and ARAS of 50% or greater.
Intervention: Stent placement and medical treatment (64 patients) or medical treatment only (76 patients). Medical treatment consisted of antihypertensive treatment, a statin, and aspirin.
Measurements: The primary end point was a 20% or greater decrease in creatinine clearance. Secondary end points included safety and cardiovascular morbidity and mortality.
Results: Forty-six of 64 patients assigned to stent placement had the procedure. Ten of the 64 patients (16%) in the stent placement group and 16 patients (22%) in the medication group reached the primary end point (hazard ratio, 0.73 [95% CI, 0.33 to 1.61]). Serious complications occurred in the stent group, including 2 procedure-related deaths (3%), 1 late death secondary to an infected hematoma, and 1 patient who required dialysis secondary to cholesterol embolism. The groups did not differ for other secondary end points.
Limitation: Many patients were falsely identified as having renal artery stenosis greater than 50% by noninvasive imaging and did not ultimately require stenting.
Conclusion: Stent placement with medical treatment had no clear effect on progression of impaired renal function but led to a small number of significant procedure-related complications. The study findings favor a conservative approach to patients with ARAS, focused on cardiovascular risk factor management and avoiding stenting.
Primary Funding Source: Dutch Kidney Foundation, Bayer, Cordis, and Pfizer.
Article and Author Information
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Acknowledgment: The authors thank Anneke Hamersma, BSc, for her coordinating role and logistical support regarding the inclusion and follow-up of the patients and Cees Haaring, BSc, for his support in data management (both from the trial office of the radiology department at University Medical Center Utrecht).
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Grant Support: By the Dutch Kidney Foundation (grant C99.1810), Bayer, Cordis (a Johnson & Johnson Company), and Pfizer.
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Potential Financial Conflicts of Interest: Consultancies: A.J.J. Woittiez (Boehringer Ingelheim, Novartis). Honoraria: G.A. van Montfrans (Novartis, Pfizer, Bristol-Myers Squibb–Sanofi), J.J. Beutler (AstraZeneca, Pfizer). In addition, the investigators involved in patient enrollment received minor compensation for time and expenses.
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Reproducible Research Statement: Study protocol: Available from Dr. Beutler (e-mail, j.beutler{at}jbz.nl) or Dr. Mali (e-mail, w.mali{at}umcutrecht.nl). Statistical code: Not available. Data set: Available from Dr. Beutler (e-mail, j.beutler{at}jbz.nl) after obtaining agreement of the steering committee.
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Requests for Single Reprints: Liesbeth Bax, MD, PhD, Department of Radiology (E01.132), University Medical Center Utrecht, Heidelberglaan 100, 3584 CX Utrecht, the Netherlands.
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Current Author Addresses: Drs. Bax, Mali, and Beek: Department of Radiology (E01.132), University Medical Center Utrecht, Heidelberglaan 100, 3584 CX Utrecht, the Netherlands.
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Dr. Woittiez: Department of Internal Medicine, Twenteborg Hospital Almelo, Zilvermeeuw 1, 7609 PP Almelo, the Netherlands.
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Dr. Kouwenberg: Department of Radiology, Twenteborg Hospital Almelo, Zilvermeeuw 1, 7609 PP Almelo, the Netherlands.
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Dr. Buskens: Department of Epidemiology, University Medical Center Groningen, Hanzeplein 1, 9713 GZ Groningen, the Netherlands.
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Dr. Braam: Division of Nephrology, Department of Medicine, University of Alberta Hospital, 11-107 Clinical Sciences Building, Edmonton, Alberta T6G 2B7, Canada.
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Dr. Huysmans: University Medical Center Nijmegen, Department of Nephrology, Geert Grooteplein-Zuid 10, 6525 GA Nijmegen, the Netherlands.
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Dr. Schultze Kool: Department of Radiology, University Medical Center Nijmegen, Geert Grooteplein-Zuid 10, 6525 GA Nijmegen, the Netherlands.
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Dr. Rutten: Department of Radiology, Jeroen Bosch Hospital, Nieuwstraat 34, 5211 NL 's-Hertogenbosch, the Netherlands.
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Dr. Doorenbos: Department of Internal Medicine, Deventer Hospital, Nico Bolkesteinlaan 75, 7416 SE Deventer, the Netherlands.
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Dr. Aarts: Department of Radiology, Deventer Hospital, Nico Bolkesteinlaan 75, 7416 SE Deventer, the Netherlands.
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Dr. Rabelink: Department of Nephrology, University Medical Center Leiden, Albinusdreef 2, 2333 ZA, Leiden, the Netherlands.
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Dr. Plouin: Department of Internal Medicine, European Hospital Georges Pompidou, 20 rue Leblanc, 75908 Paris Cedex 15, France.
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Dr. Raynaud: Department of Radiology, European Hospital Georges Pompidou, 20 rue Leblanc, 75908 Paris Cedex 15, France.
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Dr. van Montfrans: Department of Internal Medicine, Academic Medical Center, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands.
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Dr. Reekers: Department of Radiology, Academic Medical Center, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands.
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Dr. van den Meiracker: Department of Internal Medicine, Erasmus Medical Center, Dr. Molewaterplein 50-60, 3015 GE Rotterdam, the Netherlands.
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Dr. Pattynama: Department of Radiology, Erasmus Medical Center, Dr. Molewaterplein 50-60, 3015 GE Rotterdam, the Netherlands.
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Dr. van de Ven: Department of Internal Medicine, Maasstad Hospital, Olympiaweg 350, 3078 HT Rotterdam, the Netherlands.
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Dr. Vroegindeweij: Department of Radiology, Maasstad Hospital, Olympiaweg 350, 3078 HT Rotterdam, the Netherlands.
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Dr. Kroon: Department of Internal Medicine, University Hospital Maastricht, P. Debyelaan 25, 6229 HX Maastricht, the Netherlands.
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Dr. de Haan: Department of Radiology, University Hospital Maastricht, P. Debyelaan 25, 6229 HX Maastricht, the Netherlands.
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Dr. Postma: Department of Internal Medicine, University Medical Center Nijmegen, Geert Grooteplein-Zuid 10, 6525 GA Nijmegen, the Netherlands.
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Dr. Beutler: Department of Internal Medicine, Jeroen Bosch Hospital, Nieuwstraat 34, 5211NL 's Hertogenbosch, the Netherlands.
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Author Contributions: Conception and design: L. Bax, A.J.J. Woittiez, W.P.T.M. Mali, E. Buskens, F.T.M. Huysmans, T.J. Rabelink, P.F. Plouin, C.T. Postma, J.J. Beutler.
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Analysis and interpretation of the data: L. Bax, W.P.T.M. Mali, E. Buskens, F.J.A. Beek, F.T.M. Huysmans, T.J. Rabelink, C.T. Postma, J.J. Beutler.
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Drafting of the article: L. Bax, W.P.T.M. Mali, T.J. Rabelink, J.J. Beutler.
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Critical revision of the article for important intellectual content: L. Bax, A.J.J. Woittiez, H.J. Kouwenberg, W.P.T.M. Mali, E. Buskens, F.J.A. Beek, F.T.M. Huysmans, L.J. Schultze Kool, M.J.C.M. Rutten, C.J. Doorenbos, J.C.N.M. Aarts, T.J. Rabelink, P.F. Plouin, A. Raynaud, G.A. van Montfrans, J.A. Reekers, A.H. van den Meiracker, P.M.T. Pattynama, P.J.G. van de Ven, D. Vroegindeweij, A.A. Kroon, M.W. de Haan, C.T. Postma, J.J. Beutler.
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Final approval of the article: L. Bax, A.J.J. Woittiez, H.J. Kouwenberg, W.P.T.M. Mali, E. Buskens, F.J.A. Beek, B. Braam, F.T.M. Huysmans, L.J. Schultze Kool, M.J.C.M. Rutten, C.J. Doorenbos, J.C.N.M. Aarts, T.J. Rabelink, P.-F. Plouin, A. Raynaud, G.A. van Montfrans, J.A. Reekers, A.H. van den Meiracker, P.M.T. Pattynama, P.J.G. van de Ven, D. Vroegindeweij, A.A. Kroon, M.W. de Haan, C.T. Postma, J.J. Beutler.
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Provision of study materials or patients: A.J.J. Woittiez, H.J. Kouwenberg, B. Braam, F.T.M. Huysmans, L.J. Schultze Kool, M.J.C.M. Rutten, C.J. Doorenbos, J.C.N.M. Aarts, P.F. Plouin, A. Raynaud, G.A. van Montfrans, J.A. Reekers, A.H. van den Meiracker, P.M.T. Pattynama, P.J.G. van de Ven, D. Vroegindeweij, A.A. Kroon, M.W. de Haan, C.T. Postma, J.J. Beutler.
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Statistical expertise: E. Buskens.
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Obtaining of funding: W.P.T.M. Mali, E. Buskens, J.J. Beutler.
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Administrative, technical, or logistic support: L. Bax, F.J.A. Beek.
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Collection and assembly of data: L. Bax, F.J.A. Beek.
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Clinicaltrials.gov registration number: NCT00150943.
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↵* For a list of investigators, sites, and organization of the STAR (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) Trial, see the Appendix.
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