Clinical question: Which is a better approach for patients with chronic limb-threatening ischemia (CLTI): surgery or endovascular therapy?
Background: CLTI is a complication of advanced peripheral vascular disease (PVD). CLTI occurs in patients with PVD who have ischemic foot pain at rest, ischemic ulcerations, or gangrene. In addition to guideline-directed medical therapy, revascularization practices utilizing vascular surgery and endovascular therapy have both been practiced. This trial compared the clinical outcomes of these interventions.
Study design: Superiority trial that used two parallel cohort trials: Cohort 1 included patients with the ability to use a single autogenous conduit graft (using the greater saphenous vein), and Cohort 2, patients who needed an alternative bypass graft. Both cohorts were randomized into receiving surgical bypass or endovascular intervention in a 1:1 ratio.
Setting: 150 sites in five different countries. Enrollment occurred from August 2014 through October 2019 with follow-up through October 2021 (Cohort 1) and December 2019 (Cohort 2).
Synopsis: For Cohort 1, the primary composite outcome of major adverse limb event and/or death from any cause was 42.6% with surgery and 57.4% with endovascular treatment (P <0.001), with a 32% reduction in major medical events related to CLTI with surgery, a 65% reduction in re-interventions and a 27% reduction in amputations. No difference was found between the two groups in death rates alone.
For Cohort 2, the primary composite outcome was 42.8% in the surgical group and 47.7% in the endovascular group (P=0.12). There was no difference in the incidence of new or recurrent CLTI events or time until amputation or death from any cause.
Bottom line: Patients who could and did have saphenous vein grafting did better than those that received only endovascular intervention. But in patients without a saphenous vein graft option, both surgery and endovascular treatment had similar outcomes and efficacy. The major limitation is the exclusion of patients too high-risk for open vascular surgery.
Citation: Farber A, et al. Surgery or endovascular therapy for chronic limb-threatening ischemia. N Engl J Med. 2022;387(25):2305-16.
Dr. Fadden is an academic hospitalist at Richmond Veterans Affairs Medical Center and an assistant professor of medicine at Virginia Commonwealth University in Richmond, Va.