Mid-term outcome of drug coated balloon in the treatment of femoropopliteal artery disease / 中华普通外科杂志

ABSTRACT

Objective:To evaluate the mid-term outcome of drug coated balloon (DCB) in the treatment of femoropopliteal artery occlusive disease(FPOD). Methods Clinical date of FPOD patients receiving DCB treatment at Renji Hospital from Dec 2016 to Dec 2020 were retrospectively analyzed . The primary patency, primary assisted patency, secondary patency, free from clinically-driven target lesion revascularization (F-TLR) and the safety outcomes such as perioperative adverse events, major amputation rate and all-cause mortality were calculated. Results:One hurdred and seventy two patients (191 lower limbs) received DCB treatment. Among them, 13 lesions were TASC A (6.8%), 38 lesions were TASC B (19.9%), 98 lesions were TASC C (51.3%), and 42 lesions were TASC D (22.0%). One hundred and twenty six lesions were de novo lesions (66.0%), 33 lesions were in-stent restenosis (17.3%, ISR), and 32 lesions were both de novo lesions and ISR (16.8%). The average length of lesions was (27.8±10.4) mm. Fourty-eight lesions were mildly calcified (25.1%), 20 lesions were moderately calcified (10.5%), and 25 lesions were severely calcified (13.1%). Among de novo lesions, 97 lesions were chronic total occlusion (CTO) lesions (61.4%), and the average length of CTO lesions was (17.2±12.4) cm. The technical success rate was 97.4%.The provisonal stent rate was 22.0%. 12 month and 24 month after operation, the primary patency rate was 68.4% and 55.9%, the primary assisted patency rate was 78.8% and 69.8%, the secondary patency rate was 95.8% and 91.5%, and the F-TLR rate was 85.3% and 81.9%. The de novo lesion subgroup had a 24-month postoperative primary patency rate of 62.7%, while the in-stent restenosis subgroup had a rate of 44.9%.All cause mortality was 13.4% and major amputation rate was 4.7%. Chronic limb-threatening ischemia ( P=0.046) and CTO lesions length ≥15 cm ( P=0.006) were independent risk factors affecting the primary patency rate. Conclusion:DCB is a safe and effective endovascular intervention therapy for the treatment of femoropopliteal artery disease.