Long-Term Outcomes of Exercise Therapy Versus Revascularization in Patients With Intermittent Claudication

Abstract

Objective: The aim was to analyze the risk of progression to chronic limb-threatening ischemia (CLTI), amputation and subsequent interventions after revascularization versus noninvasive therapy in patients with intermittent claudication (IC). Background: Conflicting evidence exists regarding adverse limb outcomes after each treatment strategy. Methods: Preferred Reporting Items for Systematic Reviews and Meta-Analyses 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 noninvasive 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; noninvasive, 712 patients) were eligible. During a mean of 3.6-year follow-up, progression to CLTI after invasive [5 (2–8) per 1000 person-years] and noninvasive treatment [6 (3–10) per 1000 person-years] were not statistically different [rate ratio (RR): 0.77; 95% CI, 0.35–1.69; P=0.51, I 2=0%]. Incidence of amputation (RR: 1.69; 95% CI, 0.54–5.26; P=0.36, I 2=0%) and all-cause mortality (hazard ratio: 1.26; 95% CI, 0.91–1.74; P=0.16, I 2=0%) also did not differ between the groups. However, the invasive treatment group underwent significantly more revascularizations (RR: 4.15; 95% CI, 2.80–6.16; P<0.00001, I 2=83%). The 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 with noninvasive 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 noninvasive treatment for first-line IC therapy is supported.