Long-term efficacy of autologous cell therapy, repeated PTA and conservative treatment in people with diabetes and chronic limb threatening ischemia

Aim: Data about long-term clinical outcomes of revascularization procedures, especially for autologous cell therapy (ACT), in diabetic patients with chronic limb-threatening ischemia (CLTI) is lacking. The aim of our study was to compare the mortality and amputation rates in patients with diabetic foot ulcers (DFU) and CLTI treated by ACT with patients treated by repeated percutaneous transluminal angioplasty (re-PTA) and patients treated conservatively. Method: One-hundred and thirty patients with DFU and CLTI (defined as transcutaneous oxygen pressure – TcPO2˂35mmHg after unsuccessful standard revascularization) treated in our foot clinic over 9 years were enrolled into the study. Forty-five patients were treated by ACT, 43 patients underwent re-PTA and 42 patients were treated conservatively and formed the control group. Overall survival, amputation-free survival (AFS) and major amputation rate were assessed over 7-year followup period. Results/Discussion: Patients in all groups did not differ significantly in baseline demographic characteristics or comorbidities. Patients in ACT and control groups had significantly worse baseline angiograms in accordance with Graziani and GLASS (infrapopliteal region) classifications than rePTA group (both p˂0.001), but there were no differences in baseline values of TcPO2 among all groups. The rate of major amputation after 7 years was significantly lower in ACT and re-PTA groups in comparison with control group (p=0.007 and p=0.001), similar results were observed in AFS – both active groups proved significantly longer AFS compared to control (p=0.008 and p=0.003). Re-PTA group showed significantly longer overall survival compared to ACT and control groups (p=0.045 and 0.009). Conclusion: Our study showed significantly lower amputation rates and longer AFS in patients treated by ACT and re-PTA in contrast to patients treated conservatively. Overall survival was significantly longer in re-PTA group. ACT proved to be long-term effective treatment of CLTI.