[Use of plasma-free autologous platelet lysate in treatment of inoperable patients with critical limb ischemia].

Abstract

Objective: The aim of the study was to determine efficacy of using plasma-free autologous platelet lysate in inoperable patients with stage IV critical limb ischemia.

Patients and methods: We analyzed the results of treating a total of 127 inoperable patients presenting with grade IV critical limb ischemia. The inclusion criteria were as follows: the presence of necrotic defects on toes, impossibility to perform lower limb revascularization, and no history of reconstructions on the extremity concerned. The patients were divided into two groups. Group 1 (n=57) comprised patients who underwent the standard course of conservative therapy supplemented by administration of plasma-free autologous platelet lysate according to an original technique. Group 2 (n=70) was composed of patients whose treatment was limited to the standard course of conservative therapy alone. There were no statistically significant between-group differences in the clinical and demographic characteristics (p>0.05). The duration of follow-up amounted to 6 months. Therapeutic efficacy of treatment was assessed by means of a radionuclide method (three-phase scintigraphy with 99mТс-pyrfotech) used to evaluate alterations in tissue blood flow on the background of treatment.

Results: Complete healing of necrotic defects was observed in 52.6% patients of Group 1 and in 30.0% of Group 2 patients, with the rest pain relieved in 56.1 and 34.3% of patients, respectively. The mean value of the ankle-brachial index increased from 0.38 [0.31; 0.44] to 0.61 [0.52; 0.67] in Group 1 (p=0.003609) and decreased from 0.43 [0.38; 0.46] to 0.37 [0.33; 0.42] in Group 2 (p=0.02585). Clinical improvement in all patients was associated with improved microcirculation (uniform distribution of the radiopharmaceutical, a decrease of hypoperfusion zones, involution of necrotic foci as judged by no increase of the coefficient of relative accumulation of the radiopharmaceutical in the bone phase compared with the tissue one on the scintigrams). Based on the clinical and instrumental findings at six-month follow-up, we managed to achieve improvement in 61.4% of Group 1 patients and 41.4% of Group 2 patients (p<0.0001). The amputation rate amounted to 5.2% and 14.3% in Groups 1 and 2, respectively (p=0.0023). There was one lethal outcome in Group 2.

Conclusion: The use of plasma-free autologous platelet lysate in comprehensive treatment of patients with critical lower limb ischemia made it possible to improve therapeutic results in this patient cohort.