Systematic review and updated meta-analysis of the use of drug-coated balloon angioplasty versus plain old balloon angioplasty for femoropopliteal arterial disease.

OBJECTIVE: An endovascular-first approach is usually recommended in femoropopliteal occlusive disease. However, despite high technical success, plain old balloon angioplasty (POBA) is burdened with high restenosis rates. To reduce this phenomenon, local delivery of drugs has been proposed by way of drug-coated balloons (DCBs). Our goal was to review the evidence for the use of DCBs in the management of femoropopliteal disease and to determine whether it is associated with improved outcomes compared with POBA.
METHODS: Electronic searches of PubMed (MEDLINE), Embase, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, and proceedings of international conferences were performed to identify randomized controlled trials (RCTs) and observational registries evaluating the use of DCBs for femoropopliteal arterial occlusive disease.
RESULTS: This meta-analysis included 13 RCTs, 6 global registries, and 3 global registries focusing on long lesions. They all used paclitaxel in the DCB arm. There was heterogeneity between trials, and the frequency of stent deployment and duration of dual antiplatelet therapy differed. At 2 years, there were significantly better outcomes for DCBs in terms of target lesion revascularization (odds ratio [OR], 0.29; 95% confidence interval [CI], 0.20-0.40), primary patency (OR, 0.38; 95% CI, 0.27-0.54), late lumen loss (mean diameter, -0.80 mm; 95% CI, -1.44 to -0.16), and Rutherford category (OR, 0.82; 95% CI, 0.57-1.19). There was no significant difference between DCBs and POBA in amputation or change in ankle-brachial index. A subgroup analysis revealed that male patients treated with DCBs performed significantly better than female patients and that diabetics, heavily calcified lesions, and popliteal lesions performed significantly worse than nondiabetics, noncalcified and mild to moderately calcified lesions, and exclusive superficial femoral artery lesions, respectively. Secondarily stented and nonpredilated lesions did not perform significantly worse, but standard-dose (3 μg/mm2) DCBs were significantly more effective than low-dose (2 μg/mm2) DCBs in reducing binary restenosis. In addition, in a low-dose DCB, the polyethylene glycol excipient performed significantly better than polysorbate and sorbitol, whereas binary restenosis was significantly less frequent with the urea excipient, associated with a standard-dose DCB, compared with the polysorbate and sorbitol excipient, associated with a low-dose DCB.
CONCLUSIONS: DCB angioplasty is an effective treatment associated with high procedural success. In a meta-analysis of industry-sponsored trials, it consistently reduced late lumen loss, binary restenosis, and target lesion revascularization compared with POBA alone in the treatment of femoropopliteal disease. Further independent, non-industry-sponsored RCTs are necessary to better delineate the role of DCBs in the treatment of infrainguinal occlusive disease.