A Multicenter Randomized Trial Assessing ZENFlow Carrier-Free Drug-Coated Balloon for the Treatment of Femoropopliteal Artery Lesions

Abstract

Backgrounds and objectives: Drug-coated balloons (DCBs) have shown promising benefits in improving the outcomes for patients with peripheral artery disease. Several randomized clinical trials have reported that paclitaxel-coated balloon significantly reduce the rates of restenosis and the need for reintervention in comparison with regular balloon angioplasty. Due to the differences in excipients, paclitaxel dose, and coating techniques, variable clinical outcomes have been observed with different DCBs. In this study, we aimed to evaluate the safety and efficacy of a novel ZENFlow carrier-free DCB in the treatment of femoropopliteal artery occlusive disease.

Methods: In this randomized controlled trial conducted at 15 sites, 192 patients with Rutherford class 3-5 were randomly assigned into two groups: drug-coated balloon group and percutaneous transluminal angioplasty group. The primary endpoint was a late lumen loss at 6 months based on blinded angiographic core laboratory evaluations, and the secondary endpoints included primary patency rate, binary restenosis, clinically driven target lesion revascularization, ankle-brachial index, Rutherford class change, and major adverse events.

Results: In this multicenter trial, 93 patients received DCB angioplasty, whereas 99 patients underwent regular balloon angioplasty. The late lumen loss at 6-month follow-up was 0.50 ± 0.82 and 1.69 ± 0.87 mm in the drug-coated balloon and percutaneous transluminal angioplasty groups, respectively (p < 0.001). During the 12-month follow-up period, the drug-coated balloon group showed a significantly higher primary patency rate (54 vs. 31.3%, p = 0.009) and markedly lower rates of target vessel restenosis (22.1 vs. 64.3%, p < 0.001) and clinically driven target lesion revascularization rate (5.4 vs. 19.2%, p = 0.006) than the percutaneous transluminal angioplasty group. Compared with the percutaneous transluminal angioplasty group, the drug-coated balloon group had significant improvements in the ankle-brachial index and Rutherford class. The all-cause mortality rate was comparable, and no device-related deaths occurred in either groups.

Conclusions: Balloon angioplasty using a ZENFlow carrier-free drug-coated balloon is a safe and effective treatment method for femoropopliteal artery lesions. This novel drug-coated balloon catheter achieved satisfactory early and 1-year outcomes in this trial.

Clinical trial registration: https://ichgcp.net/clinical-trials-registry/NCT03844724" title="See in ClinicalTrials.gov">NCT03844724.

Keywords: drug-coated balloon; femoropopliteal artery occlusive disease; paclitaxel; percutaneous transluminal angioplasty; peripheral artery disease; restenosis.

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2022 Ni, Ye, Zhang, Jin, Shu, Jiang, Yang, Wu, Li, Yu, Yang, Huang, Wang, Li, Jiang, Wu and Liu.

Figures

Figure 1

Flow diagram of patients. *Four patients in the DCB group and one patient in the PTA group underwent angiography at 6 months but did not match the imaging quality for LLL evaluation. DCB, drug-coated balloon; DUS, duplex ultrasound; FU, follow-up; LFU, loss to follow-up; LLL, late lumen loss; PTA, percutaneous transluminal angioplasty.

Figure 2

Patient with chronic total occlusive lesion in the left SFA treated with DCB and follow-up result. (A) Preprocedure computed tomography angiography (CTA). (B) Initial angiogram during procedure. (C) Inflated balloon. (D) Postprocedure angiogram. (E) 6-month follow-up angiogram showing no restenosis of the target lesion.

Figure 3

Distribution of LLL at 6 months in the DCB and PTA groups in the intention-to-treat population (all subjects in pooled strata) and separately for each stratum (intended balloon or bailout stent groups). DCB, drug-coated balloon; LLL, late lumen loss; PTA, percutaneous transluminal angioplasty.

Figure 4

Kaplan-Meier survival analysis of freedom from CD-TLR. Data of up to 180 days post-treatment are shown. CD-TLR, clinically driven target lesion revascularization.