The midterm result of drug coated balloon with paclitaxel for the treatment of TASC C/D superficial femora-popliteal artery disease

Objective To evaluate the safety and efficacy of the drug coated balloon(DCB) for complex TASC C/D superficial femora-popliteal artery diseases. Methods Patency, target lesion revascularization (TLR) rate, clinical improvement and safety endpoints of femora-popliteal lesions in 68 patients from PLA General Hospital treated with DCB were retrospectively analyzed from June 2016 to June 2018. The mean age of the patients were (72.7±13.2) years old. Rutherford categories were from 2 to 5, and ABI baseline were 0.56±0.22. Results There were 76 limbs treated by DCB in total in this study. Mean lesion length was (26.7±15.3) cm. 73.6% of lesions were totally occluded, 26.4% were of stenosis and 61.8% were highly calcified. Stent implantation was performed in 36.8% cases. Kaplan Meier estimates of primary patency were 74.2%±7.6% and 67.7%±6.4% at 1 and 2 years, respectively, whereas freedom from TLR was 81.4%±5.1% and 73.6%±5.4%. ABI were 0.83±0.16 at 1 year, and 0.79±0.24 at 2 years. Major amputation rate was 2.9% and mortality rate was 2.9% and 4.4% at 1 year and 2 years respectively. Diabetes, highly calcification, renal insufficiency and re-stenotic lesions were identified as predictors of restenosis. Conclusions DCB are safe and effective in delaying restenosis in complex TASC C/D superficial femora-popliteal artery disease as found by midterm follow-up. Key words: Peripheral arterial diseases; Arteries; Drug coated balloon