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|Issue 155||June 2019|
The report is a product of the VA/HSR&D Evidence Synthesis Program.
Cost-Effectiveness of Leg Bypass versus Endovascular Therapy for Critical Limb Ischemia
Critical limb ischemia (CLI) is a severe form of peripheral arterial disease marked by ischemic rest pain, tissue loss, or gangrene. CLI is associated with significant morbidity, mortality, and resource utilization. Diagnostic evaluation and revascularization are important steps in the management of patients with CLI, with revascularization taking two primary forms – surgery or endovascular therapy. While the efficacy of surgical versus endovascular therapy for CLI continues to be debated, the economics are also unclear.
Thus far, only one randomized controlled trial (RCT) has compared surgery with endovascular therapy for patients with CLI—the multi-center, UK-based BASIL (Bypass versus Angioplasty in Severe Ischemia of the Leg) Study. Since the BASIL study had several limitations, additional trials - including BASIL-II and BEST-CLI - are currently underway, but results are not expected for some time.
The aim of this rapid review was to help clinicians, patients, and policymakers decide between surgery-first and endovascular-first approaches for patients with CLI. Investigators with VA's Evidence Synthesis Program in West Los Angeles, CA reviewed the literature in PubMed from 1/1/2000 to 1/16/2019 and Embase from 1/1/2000 to 1/17/2019. After conducting a full-text review of 143 publications, investigators identified 27 articles that were useful for this review, which included 5 reports from the BASIL RCT to which they added 4 cost-effectiveness models and 18 observational studies.
Summary of Findings
More recent cost-effectiveness models have found a lower incremental cost-effectiveness ratio, yet these results can only be as sound as their underlying data, for which no randomized comparisons of modern therapies have been published.
Observational studies of effectiveness and utilization have found, in general, that endovascular therapy is associated with shorter initial hospital lengths of stay and similar (or even better) short-term outcomes (e.g., 30-day mortality) than surgery; however, there are signals that longer-term outcomes like mortality and patency may favor surgical therapy. However, baseline differences between patients may be as – or more responsible for long-term differences in mortality than initial choice of endovascular or surgical therapy.
Hospital length of stay
The certainty of evidence is very low that surgical therapy has lower long-term mortality than endovascular therapy. There is a signal in the observational studies, and there is a statistically significant benefit in the one RCT, but these are subject to the same reservations about the RCT.
Cost-effectiveness by population
Register for the "Cost-Effectiveness of Leg Byass versus Endovascular Therapy for Critical Limb Ischemia" cyberseminar to be held on Monday July 1, 2019 from 3:00pm to 4:00pm EST..
Related HSR&D Research Topics:
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ESP is currently soliciting review topics from the broader VA community. Nominations will be accepted electronically using the online Topic Submission Form. If your topic is selected for a synthesis, you will be contacted by an ESP Center to refine the questions and determine a timeline for the report.
This Management e-Brief is provided to inform you about recent HSR&D findings that may be of interest. The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of the Department of Veterans Affairs. If you have any questions or comments about this Brief, please email CIDER. The Center for Information Dissemination and Education Resources (CIDER) is a VA HSR&D Resource Center charged with disseminating important HSR&D findings and information to policy makers, managers, clinicians, and researchers working to improve the health and care of Veterans.
This report is a product of VA/HSR&D's Evidence Synthesis Program (ESP), which was established to provide timely and accurate synthesis of targeted healthcare topics of particular importance to VA managers and policymakers – and to disseminate these reports throughout VA.
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