Literature

Clinical Pearls & Morning Reports

Posted by Carla Rothaus

Published December 21, 2022

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How did surgical bypass compare with endovascular therapy among patients who had a single segment of great saphenous vein that could be used for surgery in the trial by Farber et al.?

Farber et al. conducted a randomized trial that compared endovascular therapy with surgical revascularization in patients with chronic limb-threatening ischemia caused by infrainguinal peripheral artery disease. Read the NEJM Original Article here.

Clinical Pearls

Q: How common is chronic limb-threatening ischemia among patients with peripheral artery disease?

A: Chronic limb-threatening ischemia, the most severe manifestation of peripheral artery disease, is defined by ischemic foot pain at rest, ischemic ulcerations, or gangrene. More than 200 million people have peripheral artery disease worldwide; chronic limb-threatening ischemia affects up to 11% of this population. Aside from the severe health outcomes associated with chronic limb-threatening ischemia, the economic effect of the condition is substantial, with an estimated annual cost of approximately $12 billion in the United States alone.

Q: How are decisions made regarding the choice of therapy for chronic limb-threatening ischemia?

A: Treatment for chronic limb-threatening ischemia includes guideline-directed medical therapy to reduce cardiovascular risk, revascularization to improve limb perfusion, and local care to control infection and improve wound healing. Without timely revascularization, the incidence of limb amputation is approximately 25% at 1 year after diagnosis. The choice of surgery or endovascular therapy as the initial treatment varies greatly among providers and is based on the patient’s arterial disease pattern, surgical risk, availability of an autogenous conduit for vein bypass, and patient preference, along with such physician factors as training, skill set, and treatment bias. The extent to which this variability affects clinical outcomes in patients with chronic limb-threatening ischemia is unknown.

Morning Report Questions 

Q: How did surgical bypass compare with endovascular therapy among patients who had a single segment of great saphenous vein that could be used for surgery in the trial by Farber et al.?

A: The primary outcome of major adverse limb events or death from any cause occurred in 302 of 709 patients (42.6%) in the surgical group and in 408 of 711 patients (57.4%) in the endovascular group (hazard ratio, 0.68; 95% confidence interval [CI], 0.59 to 0.79; P<0.001). Major reinterventions occurred in 65 of 709 patients (9.2%) in the surgical group and in 167 of 711 patients (23.5%) in the endovascular group (hazard ratio, 0.35; 95% CI, 0.27 to 0.47). Above-ankle amputation of the index limb occurred in 74 of 709 patients (10.4%) in the surgical group and in 106 of 711 patients (14.9%) in the endovascular group (hazard ratio, 0.73; 95% CI, 0.54 to 0.98). The incidences of death from any cause and perioperative death were similar in the two groups. There were no material between-group differences in the incidence of major adverse cardiovascular events overall or at 30 days or of myocardial infarction or stroke.

Q: Was surgery also superior to endovascular therapy among patients who needed an alternative bypass conduit?

A: In this cohort of patients, the primary outcome of major adverse limb events or death from any cause occurred in 83 of 194 patients (42.8%) in the surgical group and in 95 of 199 patients (47.7%) in the endovascular group (hazard ratio, 0.79; 95% CI, 0.58 to 1.06; P = 0.12). The time until a major reintervention favored the surgical group. There were no material between-group differences in the time until above-ankle amputation or death from any cause.

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