Amputation-free survival, limb symptom alleviation and re-intervention rates after open and endovascular revascularization of femoropopliteal lesions in patients with chronic limb-threatening ischemia.

BACKGROUND: The optimal strategy for revascularization in chronic limb-threatening ischemia (CLTI) is not yet completely known and is still under debate. Endovascular treatment methods predominate despite limited evidence for their advantage. In this concurrent, prospective observational cohort study we investigated outcomes after open and endovascular revascularization in the femoropoliteal segment due to CLTI.

METHOD: Between March 2011 and January 2015, 190 patients presenting with CLTI and the principal target lesion in the superficial femoral and/or popliteal segment underwent endovascular intervention (n=117) or bypass surgery (n=73) and were followed prospectively. The choice of revascularization technique was based on international and local guidelines. All patients were followed for two years. The primary endpoint was amputation-free survival assessed with Kaplan-Meier estimates, while secondary endpoints included CLTI symptom alleviation rates and re-intervention rates. A Cox proportional hazard regression model was used to investigate risk factors for amputation and death.

RESULTS: Amputation-free survival (AFS) at two years was 59% in the endovascular group and 76% in the bypass group (p=0.020). Kaplan-Meier survival analysis confirmed a significant difference in AFS, with mortality rate as the main driver for the observed intergroup AFS difference. In sequential multivariable regression analysis the observed difference in AFS between the two groups favored bypass surgery and remained significant after controlling for covariates of known prognostic importance (HR=2.38 (95%CI 1.14-4.96). At two years, a higher proportion of patients subjected to bypass surgery remained free from ischemic rest pain, wounds, and gangrene (65% versus 45%; p=0.009). The proportions of patients who underwent re-intervention within two years were similar in the two groups (38% versus 39%; p=0.90), but repeated re-interventions were more frequent in the bypass group.

CONCLUSION: At two years, bypass surgery was associated with higher amputation-free survival than endovascular intervention, a finding that could not only be explained by differences in case mix. More patients who had bypass surgery were free from CLTI symptoms at both one and two years after revascularization. Re-interventions to maintain patency were equally common after bypass and endovascular intervention.