Early outcomes of drug-coated balloon angioplasty of infrapopliteal lesions in diabetic foot

Abstract: PURPOSE: To evaluate 6-month outcomes of drug-coated balloon (DCB) angioplasty of infrapopliteal lesions in patients with diabetic foot. METHODS: We analyzed 6-month follow-up data from the prospective PRIME-WIFI study with 203 consecutive patientswith diabetic foot who underwent DCB angioplasty for infrapopliteal arterial occlusive disease. The primary outcome was freedom from major adverse event (MAE), a composite of major amputation, all-cause death, and clinically-driven target limb reintervention (CD-TLR). Secondary outcomes included amputation-free survival (AFS), freedom from each primary outcome component, and complete wound healing. RESULTS: The mean age was 69.78 ± 9.50 years and 61 were female. A total of 271 lesions, with an average length of 26.02 ± 12.94 cm, accepted DCB angioplasty. Both infrapopliteal runoff score and pedal runoff score improved significantly after procedure compared with baseline. The score changes were − 5.73 and − 0.39, respectively (P < 0.001 for both). Within 6-month follow-up, 16 of the 203 patients died and 32 (15.76%) were lost to follow-up. By Kaplan–Meier analysis, at 6 months postprocedure, freedom from MAE was 85.77% (95% confidence interval [CI], 80.92%–90.91%); AFS was 88.88% (95% CI, 84.49%–93.49%); and freedom from major amputation, all-cause death, and CD-TLR were 95.65% (95% CI, 92.73%–98.65%), 92.57% (95% CI, 88.88%–96.4%), and 95.51% (95% CI, 92.51%–98.61%), respectively. During the 6-month follow up, complete wound healing was achieved in 67.11% patients. CONCLUSION: In patients with diabetic foot, DCB angioplasty of infrapopliteal lesions was effective and safe.