Drug-Coated Balloon Angioplasty Compared With Uncoated Balloons in the Treatment of 200 Chinese Patients With Severe Femoropopliteal Lesions: 24-Month Results of AcoArt I

Objectives

The authors sought to investigate the midterm efficacy and safety of drug-coated balloon (DCB) in the treatment of severe femoropopliteal artery disease (FPAD).

Background

The midterm outcome of DCB versus uncoated balloon percutaneous transluminal angioplasty (PTA) for FPAD are still debated.

Methods

A total of 200 Chinese patients with FPAD were prospectively randomized into treatment with DCB or with PTA. The primary efficacy endpoints were primary patency of the target lesion, freedom from clinically driven target lesion revascularization, improved ankle-brachial index, and improved Rutherford class at 24 months. The primary safety endpoint was the rate of major adverse events.

Results

The DCB group and PTA group were comparable in demographic characteristics and clinical severity at baseline. At 24-month follow-up, primary patency was better in the DCB group versus PTA group (64.6% vs. 31.4%; p < 0.001). The DCB group had a higher rate of freedom from clinically driven target lesion revascularization than the PTA group (86.5% vs. 58.9%; p < 0.001). Rutherford class and ankle-brachial index also confirmed more improvements in the DCB group (p < 0.01 and p < 0.05, respectively). There was no significant difference in major adverse events.

Conclusions

The superiority of DCB versus PTA in the efficacy of FPAD treatment persists at 24-month follow-up and the safety of DCB is equivalent to that of PTA.