Comparative Effectiveness Review Number 179 Renal Artery Stenosis Management Strategies: An Updated Comparative Effectiveness Review Comparative Effectiveness Review Number 179 Renal Artery Stenosis Management Strategies: An Updated Comparative Effectiveness Review Prepared for: Agency for Healthcare Research and Quality U.S. Department of Health and Human Services 5600 Fishers Lane Rockville, MD 20857 www.ahrq.gov Contract No. 290-2015-00002-I Prepared by: Brown Evidence-based Practice Center Providence, RI Investigators: Ethan M. Balk, M.D., M.P.H. Gowri Raman, M.D., M.S. Gaelen P. Adam, M.L.I.S. Christopher W. Halladay, B.A., Sc.M. Valerie N. Langberg, Sc.M. Ijeoma A. Azodo, M.D., Ch.M. Thomas A. Trikalinos, M.D., Ph.D. AHRQ Publication No. 16-EHC026-EF August 2016 This report is based on research conducted by the Brown Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2015-00002-I). The findings and conclusions in this document are those of the authors, who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services. None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report. The information in this report is intended to help health care decisionmakers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients. This report is made available to the public under the terms of a licensing agreement between the author and the Agency for Healthcare Research and Quality. This report may be used and reprinted without permission except those copyrighted materials that are clearly noted in the report. Further reproduction of those copyrighted materials is prohibited without the express permission of copyright holders. AHRQ or U.S. Department of Health and Human Services endorsement of any derivative products that may be developed from this report, such as clinical practice guidelines, other quality enhancement tools, or reimbursement or coverage policies, may not be stated or implied. This report may periodically be assessed for the currency of conclusions. If an assessment is done, the resulting surveillance report describing the methodology and findings will be found on the Effective Health Care Program Web site at www.effectivehealthcare.ahrq.gov. Search on the title of the report. Persons using assistive technology may not be able to fully access information in this report. For assistance contact [email protected]. Suggested citation: Balk EM, Raman G, Adam GP, Halladay CW, Langberg VN, Azodo IA, Trikalinos TA. Renal Artery Stenosis Management Strategies: An Updated Comparative Effectiveness Review. Comparative Effectiveness Review No. 179. (Prepared by the Brown Evidence-based Practice Center under Contract No. 290-2015-00002-I.) AHRQ Publication No. 16-EHC026-EF. Rockville, MD: Agency for Healthcare Research and Quality; August 2016. www.effectivehealthcare.ahrq.gov/reports/final.cfm. ii Preface The Agency for Healthcare Research and Quality (AHRQ), through its Evidence-based Practice Centers (EPCs), sponsors the development of systematic reviews to assist public- and private-sector organizations in their efforts to improve the quality of health care in the United States. These reviews provide comprehensive, science-based information on common, costly medical conditions, and new health care technologies and strategies. Systematic reviews are the building blocks underlying evidence-based practice; they focus attention on the strength and limits of evidence from research studies about the effectiveness and safety of a clinical intervention. In the context of developing recommendations for practice, systematic reviews can help clarify whether assertions about the value of the intervention are based on strong evidence from clinical studies. For more information about AHRQ EPC systematic reviews, see www.effectivehealthcare.ahrq.gov/reference/purpose.cfm. AHRQ expects that these systematic reviews will be helpful to health plans, providers, purchasers, government programs, and the health care system as a whole. Transparency and stakeholder input are essential to the Effective Health Care Program. Please visit the Web site (www.effectivehealthcare.ahrq.gov) to see draft research questions and reports or to join an email list to learn about new program products and opportunities for input. If you have comments on this systematic review, they may be sent by mail to the Task Order Officer named below at: Agency for Healthcare Research and Quality, 5600 Fishers Lane, Rockville, MD 20857, or by email to [email protected]. Andrew Bindman, M.D. Arlene S. Bierman, M.D., M.S. Director Director Agency for Healthcare Research and Quality Center for Evidence and Practice Improvement Agency for Healthcare Research and Quality Stephanie Chang, M.D., M.P.H. Elise Berliner, Ph.D. Director Task Order Officer Evidence-based Practice Center Program Center for Evidence and Practice Improvement Center for Evidence and Practice Improvement Agency for Healthcare Research and Quality Agency for Healthcare Research and Quality iii Technical Expert Panel In designing the study questions and methodology at the outset of this report, the EPC consulted several technical and content experts. Broad expertise and perspectives were sought. Divergent and conflicted opinions are common and perceived as healthy scientific discourse that results in a thoughtful, relevant systematic review. Therefore, in the end, study questions, design, methodologic approaches, and/or conclusions do not necessarily represent the views of individual technical and content experts. Technical Experts must disclose any financial conflicts of interest greater than $10,000 and any other relevant business or professional conflicts of interest. Because of their unique clinical or content expertise, individuals with potential conflicts may be retained. The TOO and the EPC work to balance, manage, or mitigate any potential conflicts of interest identified. The list of Technical Experts who provided input to this report follows: Richard Cambria, M.D. Diane Reid, M.D.* Harvard Medical School National Institutes of Health Cambridge, MA Bethesda, MD Kenneth Cavanaugh, Ph.D.* John H. Rundback, M.D., FAHA, FSVM, U.S Food and Drug Administration FSIR* Silver Spring, MD Holy Name Medical Center Teaneck, NJ Matthew Corriere, M.D., M.S.* Wake Forest University School of Medicine Stephen C. Textor, M.D., FAHA* Winston-Salem, NC Mayo Clinic Rochester, MN Joseph Nally, Jr., M.D.* Cleveland Clinic Katherine Tuttle, M.D., FACP, FASN* Cleveland, OH Providence Health Care and University of Washington School of Medicine Jeffrey Olin, M.D. Spokane, WA Icahn School of Medicine at Mount Sinai New York, NY Jonathan Winston, M.D., FAHA, FSVM, FSIR Holy Name Medical Center Teaneck, NJ *Provided input on Draft Report. iv Peer Reviewers Prior to publication of the final evidence report, EPCs sought input from independent Peer Reviewers without financial conflicts of interest. However, the conclusions and synthesis of the scientific literature presented in this report do not necessarily represent the views of individual reviewers. Peer Reviewers must disclose any financial conflicts of interest greater than $10,000 and any other relevant business or professional conflicts of interest. Because of their unique clinical or content expertise, individuals with potential nonfinancial conflicts may be retained. The TOO and the EPC work to balance, manage, or mitigate any potential nonfinancial conflicts of interest identified. The list of Peer Reviewers follows: Matthew Edwards, M.D. Wake Forest Baptist Medical Center Winston-Salem, NC Sanjay Misra, M.D., FSIR, FAHA Mayo Clinic Rochester, MN Christopher White, M.D., FACC, FAHA, MSCAI, FESC Ochsner Medical Center New Orleans, LA v Renal Artery Stenosis Management Strategies: An Updated Comparative Effectiveness Review Structured Abstract Background. Treatment options for atherosclerotic renal artery stenosis (ARAS) include medical therapy alone or renal artery revascularization with continued medical therapy, most commonly by percutaneous transluminal renal angioplasty with stent placement (PTRAS). This review updates a prior Comparative Effectiveness Review of management strategies for ARAS from 2006, which was updated in 2007. Objectives. Compare the effectiveness and safety of PTRAS versus medical therapy, and also versus surgical revascularization, to treat ARAS. Identify predictors of outcomes by intervention. Data sources. MEDLINE®, Embase®, the Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews from inception to March 16, 2016; eligible studies from the original reports and other relevant existing systematic reviews; and other sources. Review methods. We included studies comparing ARAS