OBJECTIVE: The aim was to analyze the risk of progression to chronic limb threatening ischemia (CLTI), amputation and subsequent interventions after revascularization versus non-invasive therapy in patients with intermittent claudication (IC). BACKGROUND: Conflicting evidence exists regarding adverse limb outcomes after each treatment strategy. METHODS: PRISMA guidelines were followed. MEDLINE, Web of Science, and Google Scholar were searched aided by a health sciences librarian through August 16, 2022. Randomized control trials (RCTs) comparing invasive (endovascular or surgical revascularization) and non-invasive treatment (exercise and/or medical treatment) were included. PROSPERO registration was completed (CRD42022352831). RESULTS: A total of 9 RCTs comprising 1477 patients (invasive, 765 patients; non-invasive, 712 patients) were eligible. During a mean of 3.6 year follow-up, progression to CLTI after invasive (5 (2 to 8) per 1,000 person-years) and non-invasive treatment (6 (3 to 10) per 1,000 person-years) were not statistically different (rate ratio (RR), 0.77, 95% confidence interval (CI) 0.35 to 1.69, p = 0.51, I2 0%). Incidence of amputation (RR, 1.69, 95% CI 0.54 to 5.26, p = 0.36, I2 0%) and all-cause mortality (hazard ratio, 1.26, 95% CI 0.91 to 1.74, p = 0.16, I2 0%) also did not differ between the groups. However, the invasive treatment group underwent significantly more revascularizations (RR, 4.15, 95% CI 2.80 to 6.16, p < 0.00001, I2 83%). Results were not changed by fixed effect or random-effects models, nor by sensitivity analysis. CONCLUSIONS: Although there is equivalent risk of progression to CLTI, major amputation and all-cause mortality compared to non-invasive treatment, invasive treatment for patients with IC led to significantly more revascularization procedures and should be used selectively in patients with major lifestyle limitation. Guideline recommendation of non-invasive treatment for first-line IC therapy is supported.
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