Abstract:

Objective To evaluate the efficacy and safety of Acotec drug⁃coated balloon（DCB）for chronic ischemic disease in lower extremity. Methods Clinical data of 427 patients with 528 occlusive/stenotic lesions in 481 lower extremities treated by DCB from April 2016 to January 2020 were retrospectively analyzed. The mean age was 67 years. Rutherford stage 2，3，4，5，and 6 were classified in 12（2.5%），168（34.9%），179（37.2%），94 （19.5%），and 28（5.8%）limbs，respectively. The mean length of the targeted lesions was 228.5 mm. Of all lesions， 433 were located at femoral and/or popliteal arteries，and 95 were at infra⁃popliteal arteries. All the patients were followed up for 6 months. The major evaluation endpoints included late lumen loss（LLL），target lesion restenosis， target lesion revascularization（TLR），and severe clinical events including mortality and major amputation. Results The technique success rate was 97.5%. Stents were placed in 59（13.8%）cases for flow ⁃limited dissections or remnant stenosis greater than 50% after DCB angioplasty. The median follow ⁃ up time was 27months（12 ~ 45 months）. The mean LLL was（1.00 ± 0.30），（1.73 ± 0.41），（2.14 ± 0.40）mm，respectively，1，2，and 3 years after operation. The restenosis rate at 1，2 and 3⁃year was 17.1% vs. 24.1%（P = 0.151），18.4% vs. 29.8%（P = 0.070），and 26.7% vs. 36.7%（P = 0.277），respectively，in femoropopliteal and BTK arm，and the TLR rate was 8.0% vs. 16.5%（P = 0.032），9.9% vs. 19.3%（P = 0.065），and 15.9% vs. 23.3%（P = 0.303），respectively. Twenty⁃three patients died and 33 received major amputation. Conclusions Acotec DCB was safe and effective in treating chronic ischemic diseases of lower extremities. Compared with infrapopliteal arteries ，a better clinical outcome was achieved in femoro⁃popliteal arteries.

Key words: peripheral arterial occlusive disease； , percutaneous transluminal angioplasty； , drug coated balloon