Objective: The optimal revascularization strategy in diabetic patients with chronic critical limb ischemia (CLI) is unclear. This study assessed the efficacy of tailored endovascular-first vs surgical-first revascularization stratified for the presence of diabetes.
Methods: This prospective cohort study, with 1-year follow up, was conducted in a tertiary referral center in a consecutive series of 383 patients (45.7% had diabetes) presenting 426 limbs with chronic CLI. Interventions were endovascular (PTA cohort, 207 limbs) or surgical (SURG cohort, 85 limbs) revascularization. Conservatively treated patients without revascularization (NON REVASC cohort, 108 limbs) were used as a reference. The main outcome measures were sustained clinical success, defined as survival without major amputation or repeated target extremity revascularization (TER), and a categoric upward shift in clinical symptoms according to the Rutherford classification.
Results: Sustained clinical success of revascularization was significantly better in nondiabetic patients (hazard ratio [HR], 0.48; 95% confidence interval [CI], 0.29 to 0.72; P = .001 [SURG cohort]; HR, 0.53; 95% CI, 0.35 to 0.78; P = .002 [PTA cohort]) compared with diabetic patients (HR, 0.78; 95% CI, 0.44 to 1.43, P = .45 [SURG cohort]; HR, 0.83; 95% CI, 0.55 to 1.27, P = .40 [PTA cohort]). Repeated TER significantly improved clinical success, which became equivalent between diabetic and nondiabetic patients (HR, 1.02; 95% CI, 0.7 to 1.4). In multivariate analysis, treatment success was not influenced by mode of initial revascularization, neither in diabetic nor in nondiabetic patients. Cumulative 1-year mortality was 30.4%, with a trend of increased mortality in patients with diabetes (HR, 1.45; 95% CI, 0.98 to 2.17; P = .064). Limb salvage rates were similar in treatment cohorts, also if stratified for diabetes (HR, 1.04; 95% CI, 0.62 to 1.75).
Conclusion: Diabetic patients with chronic CLI benefit from early revascularization. To achieve this benefit, multiple revascularization procedures may be required, and close surveillance is therefore mandatory. Choice of initial revascularization modality seems not to influence clinical success.