Twelve-Month Outcomes of a Novel Iopromide-Based Paclitaxel-Coated Balloon for the Treatment of Chronic Total Occlusion of Femoropopliteal Arteries.

Abstract

Objective: We designed a retrospective study to evaluate the performance and outcomes of a novel iopromide-based paclitaxel-coated balloon for the treatment of chronic total occlusion of femoropopliteal arteries.

Methods: Patients with femoropopliteal chronic total occlusion (<100 mm) on angiogram were screened from hospital management system and were included in the study. The width and length of the drug-eluting peripheral balloon was chosen to ensure a vessel/balloon ratio of 1: 1 and exceed the lesion by 10 mm on both ends (based on visual estimation).

Results: The proportion of patients with ankle-brachial index improvement was 89.8% (106 of 118). The mean ankle-brachial index was 0.5 (0.4-0.7) at baseline and 0.8 (0.7-0.9) at 12 months (P < 0.001). Changes in the Rutherford category between baseline and 12 months were statistically significant (P < 0.001), with the majority of patients (77.9%, 92/118) having ≥1 level improvement. The rate of clinically driven target lesion revasculariza-tion at 12 months was 13.5%(16/118). Overall, the 1-year primary patency rate was 86.4% (102 of 118). The major adverse limb event rate was 9.8% (16/162). Acute limb ischemia was detected in 14 patients, and amputation was performed in 2 patients.

Conclusion: Our study is a non-randomized clinical study focusing on the use of drug-eluting balloon as a single treatment strategy. There was significant clinical benefit to patients, as clearly demonstrated by the improvement in ankle-brachial index and the reduction in Rutherford class in the short term, and these results may offer clear insights on the revascularization strategy outlook of interventionalists.