Comparison of open and endovascular treatment of patients with critical limb ischemia in the Vascular Quality Initiative.

OBJECTIVE: There is significant controversy in the management of critical limb ischemia (CLI) arising from infrainguinal peripheral arterial disease. We sought to compare practice patterns and perioperative and long-term outcomes for patients undergoing lower extremity bypass (LEB) and percutaneous vascular interventions (PVIs) for CLI in the Vascular Quality Initiative (VQI).
METHODS: The prospectively collected VQI (2010-2013) LEB and PVI databases were retrospectively queried. Demographics, comorbidities, and perioperative outcomes were recorded. We evaluated all patients (cohort 1), those without comorbidities known to increase surgical risk (cohort 2) to control for patient factors, and patients with treatment anatomically limited to the superficial femoral artery (cohort 3) to control for anatomic factors. Multivariable analyses were performed to identify predictors of outcomes.
RESULTS: There were 7897 patients with CLI and infrainguinal peripheral arterial disease, 4838 treated with PVI and 3059 with LEB. PVI patients had more comorbidities across all cohorts, whereas those undergoing LEB were more likely to have had a previous revascularization procedure. Follow-up at 1 year was 45.8% for PVI and 53.5% for LEB. After adjustment for comorbidities, cohort 1 patients treated with PVI vs LEB had lower odds of in-hospital or 30-day mortality (odds ratio [OR], 0.59; 95% confidence interval [CI], 0.43-0.81; P = .001). This difference was not seen for the lower risk (cohort 2) patients (OR, 0.66; 95% CI, 0.39-1.14; P = .134) or the superficial femoral artery-only (cohort 3) patients (OR, 1.25; 95% CI, 0.53-2.96; P = .604). The 3-year mortality was higher with PVI in cohort 1 (HR, 1.23; 95% CI, 1.07-1.42; P = .003) and cohort 2 (HR, 1.63; 95% CI, 1.32-2.02; P < .001) but not cohort 3 (HR, 1.18; 95% CI, 0.82-1.71; P = .368). Amputation or death at 1 year was similar for PVI vs LEB in cohort 1 (HR, 0.98; 95% CI, 0.82-1.16; P = .816), cohort 2 (HR, 0.89; 95% CI, 0.7-1.15; P = .37), and cohort 3 (HR, 1.67; 95% CI, 0.86-3.2; P = .13). Major adverse limb event or death was lower for PVI at 1 year in cohort 1 (HR, 0.81; 95% CI, 0.72-0.91; P < .001) and cohort 2 (HR, 0.83; 95% CI, 0.71-0.97; P = .02) but not in cohort 3 (HR, 1.25; 95% CI, 0.85-1.84; P = .259). Length of stay for PVI was lower in all cohorts.
CONCLUSIONS: In the VQI, PVI was more frequently offered to patients who were older and had more comorbidities, and LEB patients were more likely to have a history of previous interventions. Patients treated with PVI had lower perioperative mortality overall, although this benefit was not seen when treating patients with fewer comorbidities or less advanced disease. However, PVI patients had higher adjusted 3-year mortality in the overall sample and in lower-risk patients. Limitations to this study, especially the follow-up, hamper meaningful interpretation of reinterventions and further reinforce the need for large, randomized, clinical studies with better long-term follow-up.