Critical limb ischemia (CLI) is a severe form of peripheral arterial disease (PAD) marked by ischemic rest pain, tissue loss, or gangrene.¹ CLI is associated with significant morbidity, mortality, and resource utilization, not only from the disease itself but because it serves as a harbinger for associated medical conditions.

Diagnostic evaluation and revascularization are important steps in the management of patients with CLI, with revascularization taking 2 primary forms – surgery or endovascular therapy. To date, only 1 randomized controlled trial (RCT) has compared these 2 revascularization strategies in patients with CLI – the multi-center UK-based BASIL study randomized 452 patients with CLI due to infra-inguinal disease to a surgery-first or angioplasty-first management strategy.² They found no difference in their primary endpoint of above-the-ankle amputation or death. However, the study has a number of limitations. Concerns have been expressed that the study was underpowered and that modern surgical and endovascular techniques and materials were not included. Two additional trials – BASIL-II and BEST-CLI – are currently under way to help remedy these limitations, but the results are not expected for some time. Current guidelines from the American College of Cardiology (ACC) and American Heart Association (AHA) published in 2016 do not specifically recommend endovascular or surgical therapy first for patients with CLI.³

While the efficacy of surgical versus endovascular therapy for CLI continues to be debated, the economics of these decisions are also unclear. A 2011 systematic review found the literature insufficient to draw cost-efficacy conclusions as it relates to open versus endovascular therapy in patients with either claudication (a less serious symptom of PAD) or CLI.⁴

To help clinicians, patients, and policymakers decide between surgery-first and endovascular-first approaches in patients with CLI, we were asked to conduct a systematic review of the literature.