Clinical Outcomes of Combined Interventional Therapy for Below-The-Knee Arterial Lesions in Patients with Diabetic Foot: A Prospective Cohort Study.

BACKGROUND

This study aimed to assess the clinical outcomes of combined interventional therapy (CIT) for below-the-knee (BTK) arterial lesions in individuals with diabetic foot (DF).

METHODS

A prospective cohort study was conducted involving 138 patients with DF and BTK arterial lesions who underwent BTK arterial revascularization. Participants were assigned to one of 2 treatment groups: the control group received percutaneous transluminal angioplasty (PTA) with a drug-coated balloon (DCB), while the experimental group underwent excimer laser atherectomy (ELA) followed by DCB-PTA. All participants were followed for 12 months. Outcomes compared between groups included primary patency rate (PPR), target lesion revascularization rate (TLRR), primary wound healing rate (PWHR), secondary wound healing rate (SWHR), primary wound healing rate without revascularization (PWHRR), wound healing time (WHT), major amputation rate, and mortality rate.

RESULTS

The overall PPR was 63.80%, with a higher rate in the experimental group (74.10%) compared with the control group (56.30%) (χ2 = 4.657, P = 0.031). The overall TLRR was 20.30%, with a lower rate in the experimental group (8.60%) compared with the control group (28.70%) (χ2 = 8.424, P = 0.004). The overall PWHR was 77.50%, with the experimental group demonstrating a higher rate (89.70%) compared with the control group (68.80%) (χ2 = 8.436, P = 0.004). The median WHT was 108.50 days; the experimental group achieved a shorter healing time (82.00 days) compared with the control group (128.00 days) (Z = 6.680, P < 0.001).

CONCLUSION

CIT demonstrated safety and efficacy in the management of BTK arterial lesions in individuals with DF, yielding improved vessel patency, lower revascularization rates, higher wound healing rates, and reduced healing times compared with drug-coated balloon PTA alone.