Short-term therapeutic efficacy analysis of drug-coated balloon combined with chocolate balloon for the treatment of femoropopliteal artery lesions.

Background: To report our experience of short-term results of drug-coated balloon (DCB) combined with chocolate balloon in the treatment of femoropopliteal artery lesions.

Methods: From June 2021 to December 2022, patients with femoropopliteal artery lesions (Rutherford classification 2-6) who underwent DCB combined with Chocolate PTA balloon catheter treatment were included. Clinical data of the patients were collected, and follow-up was conducted at 3, 6, and 12 months. The primary patency rate and the freedom from clinically-driven target lesion revascularization (f-TLR) rate were calculated by Kaplan-Meier survival curves.

Results: This study included a total of 43 patients (mean age 72.84 ± 10.19 years, male proportion 67.4%) with 47 lesions. Among them, 17 lesions (36.2%) presented severe stenosis with an average lesion length of 110.41 ± 47.67 mm. Thirty lesions (63.8%) were identified as chronic total occlusions (CTO), with an average occlusion length of 104.13 ± 61.12 mm. The Kaplan-Meier survival curve estimated a primary patency rate of 87.2% at 6 months and 78.7% at 12 months. The f-TLR rate at 12 months was 85.1%, estimated by Kaplan-Meier survival curve. The mean ankle-brachial index (ABI) increased from 0.53 ± 0.12 before the surgery to 0.87 ± 0.12 at 12 months postoperatively, and this difference was statistically significant (p < 0.001). A total of 91.5% of patients (43/47) showed a decrease in Rutherford classification at 12 months postoperatively. The proportion of patients with Rutherford class 4-6 decreased from 70.2% (33/47) preoperatively to 4.3% (2/47) at 12 months postoperatively, and this difference was statistically significant (p < 0.001). Among the limbs, 34 (72.3%) experienced dissection during the surgery, with 29 cases classified as type B or lower dissection and 5 cases classified as type C or higher (severe dissection) (10.6%). Two limbs (4.3%) required the use of salvage stents. There were no procedure- or device-related deaths within the 12-month period. Twelve limbs (25.5%) underwent minor amputations (toe amputations).

Conclusion: The combination of DCB and chocolate balloon angioplasty has achieved satisfactory patency rates and f-TLR results in 1-year follow-up for the treatment of femoropopliteal artery lesions. However, further confirmation of these findings is needed through multicenter data and long-term follow-up results.