Evaluation of long-term treatment results of patients with critical limb ischemia and diabetes mellitus with different management approaches

Abstract

Background. In all cases of critical lower limb ischemia revascularization should be performed. However, the overlay of diabetic angiopathy significantly worsens the prognosis of the surgery, and the conservative therapy also frequently turns out to be ineffective even in the nearest future. Therapeutic stimulation of angiogenesis in this group of patients is an additional application point for the possible improvement of treatment results.

Aim. Evaluating treatment results of patients with critical ischemia and underlying diabetes after 5 years from the beginning of supervising, as well as assessing the benefits of additional angiogenesis as a part of treatment.

Material and methods. The study included data from 140 patients with critical ischemia and diabetes mellitus, divided into 4 groups, who received surgical [groups IA (n=45) and IB (n=30)] or therapeutic [groups IIA (n=40) and IIB (n=25)] treatment. Additional angiogenic therapy was also carried out in two groups (groups IB and IIB). Treatment outcomes were assessed over a 5-year period. Efficacy criteria were evaluated in the form of limb preservation and patient survival. The results were studied using descriptive statistics methods. Qualitative data were analyzed by constructing 2×2 contingency tables and using the xi-square method.

Results. The best indices of limb preservation and the lowest mortality of patients were obtained in the group after revascularization with additional angiogenic therapy. Gene therapy induction significantly improved the course of disease in limb preservation for periods from 6 months to 2 years (30% amputations by 2 years of follow-up, p=0.045). Angiogenic induction of angiogenesis also made it possible to improve the treatment results in the groups of conservative therapy but reliably better indicators of limb preservation were obtained in two groups with surgical interventions.

Conclusion. The optimal management tactic for patients with critical lower limb ischemia and underlying diabetes mellitus is direct revascularizing intervention on the lower limb arteries with additional angiogenic therapy in the postoperative period. Additional gene therapy induction of angiogenesis makes it possible to reduce the number of amputations both as part of combined surgical or therapeutic treatment , but it cannot be an alternative to surgery.

Keywords

atherosclerosis / critical ischemia of the lower limbs / diabetes mellitus / angiogenic induction / gene therapy

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