This article was originally published here
Ann Vasc Surgery. December 10, 2021: S0890-5096(21)00917-1. doi: 10.1016/j.avsg.2021.10.066. Online before printing.
Purpose: Restenosis is a common complication after endovascular treatment of peripheral arterial disease. Drug-coated balloon (DCB) therapy has been proven to be safe and effective, reducing the rate of restenosis in simple and short lesions. However, the clinical results of DCBs for long lesions are still very limited. This study aims to evaluate the effectiveness and safety of DCBs in the treatment of long femoral popliteal artery disease. The results of this study will also supplement the existing evidence of DCB treatment of long lesions.
Methods: According to computed tomography angiography (CTA) or angiography in the AcoArt I study, patients with lesions ≥ 15 cm in length were included in this study. According to the balloon catheter used during treatment, patients were divided into DCB group and percutaneous transluminal angioplasty (PTA) group. The demographic, pathological and surgical characteristics of the two groups and the results of the 24-month follow-up were compared. The primary efficacy endpoint is angiographic late lumen loss (LLL), primary patency (PP), freedom from CD-TLR and changes in the ankle brachial artery at 6 months or clinically driven target lesion revascularization (CD-TLR) . During the 24-month follow-up period, the index (ABI) and Rutherford grade. The safety endpoint is the occurrence of major adverse events.
Results: A total of 87 patients, including 42 in the DCB group and 45 in the PTA group. There were no significant differences between the two groups in demographics, disease, and surgical characteristics. The 6-month follow-up angiography showed that the LLL of the DCB group was significantly smaller than that of the PTA group (0.27 ± 0.90 mm vs 1.32 ± 0.91 mm; P<0.001). At 24 months, compared with the PTA group, the CD-TLR free rate in the DCB group was significantly higher (81.58% vs 43.18%; P<0.001), and the PP rate was significantly higher (46.88% vs 15.00%; P= 0.003). The ABI of the DCB group at 6, 12, and 24 months was significantly higher than that of the PTA group (P<0.001, P=0.004, and P=0.018, respectively). The DCB group had better Rutherford grades at 6 and 12 months than the PTA group (P=0.033 and P=0.012, respectively); at 24 months, there was no significant difference in Rutherford grade between the two groups (P =0.127). The incidence of major adverse events did not differ significantly between the two groups.
Conclusion: During the 24-month follow-up period, DCB is more effective than standard uncoated balloons in treating long lesions. In addition, the security of DCB is the same as PTA.