Gowri Raman, MD, MS; Gaelen P. Adam, MLIS; Christopher W. Halladay, BA, ScM; Valerie N. Langberg, ScM; Ijeoma A. Azodo, MD, ChM; Ethan M. Balk, MD, MPH
Disclaimer: The findings and conclusions in this article are those of the authors, who are responsible for its content, and do not necessarily represent the views of AHRQ. No statement in this article should be construed as an official position of AHRQ.
Acknowledgment: The authors thank the members of the technical expert panel: Richard Cambria, MD (Harvard Medical School, Cambridge, Massachusetts); Kenneth Cavanaugh, PhD (U.S. Food and Drug Administration, Silver Spring, Maryland); Matthew Corriere, MD, MS (Wake Forest University School of Medicine, Winston-Salem, North Carolina); Joseph Nally Jr., MD (Cleveland Clinic, Cleveland, Ohio); Jeffrey Olin, MD (Icahn School of Medicine at Mount Sinai, New York, New York); Diane Reid, MD (National Institutes of Health, Bethesda, Maryland); John H. Rundback, MD (Holy Name Medical Center, Teaneck, New Jersey); Stephen C. Textor, MD (Mayo Clinic, Rochester, Minnesota); Katherine Tuttle, MD (Providence Health Care and University of Washington School of Medicine, Spokane, Washington); and Jonathan Winston, MD (Holy Name Medical Center, Teaneck, New Jersey).
Financial Support: Under contract 290-20-1500002 I from the Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services.
Disclosures: Drs. Raman and Balk report grants from the Agency for Healthcare Research and Quality during the conduct of the study. Authors not named here have disclosed no conflicts of interest. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M16-1053.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer and Johnson & Johnson.
Reproducible Research Statement:Study protocol: Available at www.effectivehealthcare.ahrq.gov (published online on 20 January 2015). Statistical code: No statistical code was written for this review. Data set: Available at http://srdr.ahrq.gov.
Requests for Single Reprints: Ethan Balk, MD, MPH, Brown University School of Public Health, Box G-S121-8, Providence, RI 02912; e-mail, firstname.lastname@example.org.
Current Author Addresses: Dr. Raman: Tufts Medical Center, Box 063, 800 Washington Street, Boston, MA 02111.
Ms. Adam, Mr. Halladay, Ms. Langberg, and Dr. Balk: Brown University School of Public Health, Box G-S121-8, Providence, RI 02912.
Dr. Azodo: College of Medicine and Veterinary Medicine, University of Edinburgh, 47 Little France Crescent, Edinburgh EH16 4TJ, United Kingdom.
Author Contributions: Conception and design: G. Raman, E.M. Balk.
Analysis and interpretation of the data: G. Raman, C.W. Halladay, V.N. Langberg, I.A. Azodo, E.M. Balk.
Drafting of the article: G. Raman, C.W. Halladay, V.N. Langberg, I.A. Azodo, E.M. Balk.
Critical revision of the article for important intellectual content: G. Raman, C.W. Halladay, V.N. Langberg, I.A. Azodo, E.M. Balk.
Final approval of the article: G. Raman, G.P. Adam, C.W. Halladay, V.N. Langberg, I.A. Azodo, E.M. Balk.
Provision of study materials or patients: C.W. Halladay.
Statistical expertise: G. Raman, C.W. Halladay, V.N. Langberg, E.M. Balk.
Obtaining of funding: E.M. Balk.
Administrative, technical, or logistic support: G.P. Adam.
Collection and assembly of data: G. Raman, G.P. Adam, C.W. Halladay, V.N. Langberg, I.A. Azodo, E.M. Balk.
Atherosclerotic renal artery stenosis (ARAS) is associated with high blood pressure (BP), decreased kidney function, renal replacement therapy (RRT), and death.
To compare benefits and harms of percutaneous transluminal renal angioplasty with stent placement (PTRAS) versus medical therapy alone in adults with ARAS.
MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials from 1993 to 16 March 2016; gray literature; and prior systematic reviews.
Randomized, controlled trials (RCTs); nonrandomized, comparative studies (NRCSs); single-group studies; and selected case reports that reported all-cause and cardiovascular mortality, RRT, kidney function, BP, and adverse events.
Six researchers extracted data on design, interventions, outcomes, and study quality into a Web-based database.
Eighty-three studies met eligibility criteria. In 5 of 7 RCTs, PTRAS and medical therapy led to similar BP control in patients with ARAS, and no RCTs showed statistically significant differences in kidney function, mortality, RRT, cardiovascular events, or pulmonary edema. Eight NRCSs had more variable results, finding mostly no significant differences in mortality, RRT, or cardiovascular events but heterogeneous effects on kidney function and BP. Procedure-related adverse events were rare, and medication-related adverse events were not reported. Two RCTs found no patient characteristics that were associated with outcomes with either PTRAS or medical therapy. Single-group studies found various but inconsistent factors that predict outcomes. Case reports provided examples of clinical improvement after PTRAS in patients with acute decompensation.
Limited clinical applicability and power in RCTs, and possible publication bias and lack of adjusted analyses in NRCSs.
The strength of evidence regarding the relative benefits and harms of PTRAS versus medical therapy alone for patients with ARAS is low. Studies have generally focused on patients with less severe ARAS.
Agency for Healthcare Research and Quality.
Literature flow diagram.
ARAS = atherosclerotic renal artery stenosis; NRCS = nonrandomized, comparative study; PTRAS = percutaneous transluminal renal angioplasty with stent placement; RCT = randomized, controlled trial.
* Does not include studies that were screened and excluded for the 2006 report.
† Studies of open surgical revascularization and other noncomparative studies are reported elsewhere (11).
Table 1. Characteristics and Main Results of Comparative Studies of PTRAS Versus Medical Therapy
Forest plot of effect size of death in adults with renal artery stenosis receiving PTRAS versus medical therapy alone.
HR = hazard ratio; ND = no data; OR = odds ratio; PTRAS = percutaneous transluminal renal angioplasty with stent placement.
Forest plot of effect size of incident renal replacement therapy in adults with renal artery stenosis receiving PTRAS versus medical therapy alone.
OR = odds ratio; PTRAS = percutaneous transluminal renal angioplasty with stent placement.
Forest plot of net change in SBP in adults with renal artery stenosis receiving PTRAS versus medical therapy alone.
PTRAS = percutaneous transluminal renal angioplasty with stent placement; SBP = systolic blood pressure; UK = study cohorts from the United Kingdom.
Forest plot of net change in DBP in adults with renal artery stenosis receiving PTRAS versus medical therapy alone.
DBP = diastolic blood pressure; PTRAS = percutaneous transluminal renal angioplasty with stent placement; UK = study cohorts from the United Kingdom.
Table 2. Periprocedural Complications With PTRAS
Table 3. Strength of Evidence
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Franz H. Messerli, MD
August 26, 2016
In their thorough review Raman et al. (1) came to the conclusion that “the evidence does not support a benefit with PTRAS over medical therapy alone in most patients with ARAS”. This would indicate that most patients with atherosclerotic renal artery stenosis do not have a form of hypertension that is remediable or improved by angioplasty; to expose them to the cost, inconvenience, and risk of a diagnostic work-up add up to little more than a wild goose chase (2). Thus patients with atherosclerotic renal artery stenosis and hypertension should not be classified as having “renovascular hypertension.” The central clinical tenet of many years, even decades, to search for renovascular hypertension in patients with treatment resistant hypertension, has crumbled. If renal imaging will be used in this setting, it merely adds cost and potential risk without any likelihood of benefit. One can argue that measuring translesional gradients (3) or age (4) may help to identify patients whose BP my be more responsive to angioplasty. However, with very few exceptions, medical therapy with anti hypertensive drugs and statins remains the cornerstone for the management of patients with atherosclerotic renal artery stenosis and hypertension. As Raman et al. point out, renal revascularization most likely remains the treatment of choice only in patients with Pickering Syndrome, a clinical emergency comprising of hypertension, flash pulmonary edema, and bilateral renal artery stenosis (5)1. Raman, G; Adam, Gaelen P.; Halladay, C W.;. Langberg, V N; Azodo, I A.; and Balk, E M.. Comparative Effectiveness of Management Strategies for Renal Artery Stenosis: An Updated Systematic Review. Ann Intern Med. Published online 16 August 20162. Bavishi C, de Leeuw PW, Messerli FH. Atherosclerotic Renal Artery Stenosis and Hypertension: Pragmatism, Pitfalls, and Perspectives. Am J Med. 2016 Jun;129(6):635.e5-635.e14. doi: 10.1016/j.amjmed.2015.10.010. Epub 2015 Oct 29.3. Mangiacapra F, Trana C, Sarno G, Davidavicius G, Protasiewicz M, Muller O,Ntalianis A, Misonis N, Van Vlem B, Heyndrickx GR, De Bruyne B. Translesionalpressure gradients to predict blood pressure response after renal artery stentingin patients with renovascular hypertension. Circ Cardiovasc Interv 2010;3:537–542. 4. Streeten DH, Anderson GH Jr,Wagner S. Effect of age on response of secondaryhypertension to specific treatment. Am J Hypertens 1990;3:360–365.
Raman G, Adam GP, Halladay CW, Langberg VN, Azodo IA, Balk EM. Comparative Effectiveness of Management Strategies for Renal Artery Stenosis: An Updated Systematic Review. Ann Intern Med. [Epub ahead of print 16 August 2016]165:635–649. doi: 10.7326/M16-1053
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Published: Ann Intern Med. 2016;165(9):635-649.
Published at www.annals.org on 16 August 2016
Cardiology, Coronary Risk Factors, Hypertension, Nephrology.
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