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Renal Artery Stenosis Management Strategies
Comparative Effectiveness Reviews, No. 179
Investigators: Ethan M Balk, MD, MPH, Gowri Raman, MD, MS, Gaelen P Adam, MLIS, Christopher W Halladay, BA, ScM, Valerie N Langberg, ScM, Ijeoma A Azodo, MD, ChM, and Thomas A Trikalinos, MD, PhD.
Author Information and AffiliationsStructured 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 interventions, single-group prospective PTRAS and medical therapy studies, and prospective or retrospective surgery studies. We also included 20 recent case reports of patients with acute ARAS decompensation. Outcomes included all-cause and cardiovascular mortality, cardiovascular events, renal replacement therapy (RRT), other kidney events and function, hypertension events, blood pressure (BP), medication use, and adverse events.
Results:
From 1,454 citations, we included 78 studies and 20 case reports. We included 9 randomized controlled trials (RCTs), 11 nonrandomized comparative studies, 67 cohorts (in 63 studies) of PTRAS; 20 cohorts (in 17 studies) of medical therapy alone; and 4 cohorts of surgery. For the primary comparison of PTRAS versus medical therapy, seven RCTs found no difference in mortality, RRT, cardiovascular events, or pulmonary edema. They mostly found no difference in kidney function or BP control after PTRAS. Procedural adverse events were rare but medication-related adverse events were not reported. The nonrandomized studies were more variable than the RCTs and found no significant difference in mortality, but heterogeneous effects on kidney function and BP control after PTRAS. All 20 case reports describe patients with successful clinical and symptomologic improvement after revascularization. In subgroup analyses, two RCTs found no patient characteristics associated with outcomes between PTRAS and medical therapy. In one retrospective comparative study, patients with flash pulmonary edema or both rapidly declining kidney function and refractory hypertension had decreased mortality with PTRAS (vs. medical therapy). Single-intervention studies found that various factors predicted outcomes.
Conclusions:
There is a low strength of evidence of no statistically significant or minimal clinically important differences in important clinical outcomes (death, cardiovascular events, RRT) or BP control between PTRAS and medical therapy alone, and that kidney function may improve with PTRAS. Clinically important adverse events related to PTRAS are rare; however, studies generally did not report medication-related adverse events. Based on the evidence, subsets of patients benefit from revascularization, but the evidence does not clearly define who these patients are, except that case reports demonstrate that some patients with acute decompensation benefit from revascularization. Evidence is limited regarding differences in outcomes based on different PTRAS-related treatments. The RCTs had limited applicability to many patients for whom PTRAS is recommended, particularly those who present with pulmonary edema or rapidly declining kidney function. All nonrandomized trials were inadequately adjusted to account for underlying differences between patients undergoing different interventions. New studies or reanalyses of data in existing studies are needed to better understand the comparative effectiveness of PTRAS versus medical therapy.
Contents
- Preface
- Technical Expert Panel
- Peer Reviewers
- Executive Summary
- Introduction
- Methods
- Technical Expert Panel
- Search Strategy
- Study Selection
- Population and Condition of Interest
- Interventions of Interest
- Comparators of Interest
- Outcomes of Interest
- Years of Intervention of Interest
- Study Designs of Interest
- Data Extraction
- Risk of Bias Assessment
- Data Synthesis
- Minimal Clinically Important Differences
- Grading the Strength of Evidence
- Peer Review
- Results
- Discussion
- References
- Abbreviations
- Appendix A Search Strategy
- Appendix B Excluded Studies
- Appendix C Summary Tables
- Appendix D Risk of Bias Assessment
Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services1, Contract No. 290-2012-00012-I, Prepared by: Brown Evidence-based Practice Center, Providence, RI
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. 290-2012-00012-I.) AHRQ Publication No. 16-EHC026-EF. Rockville, MD: Agency for Healthcare Research and Quality; August 2016. www.effectivehealthcare.ahrq.gov/reports/final.cfm.
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. 290-2012-00012-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.
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.
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