[Drug-coated Balloon Angioplasty in Femoropopliteal Arteries - Is There a Class Effect?]

Abstract

Aim Percutaneous transluminal angioplasty (PTA) is a well-accepted method to re-establish patency in stenotic and reoccluded vessels. One tool to improve results may be to use paclitaxel drug-coated balloon (DCB) catheters. This systematic review investigates whether there is a class effect among different DCBs. Methods The primary endpoint was "Freedom from Target Lesion Revascularisation" (FfTLR) after 12 months. A systematic literature search was performed in PubMed and risk of bias was assessed of the included trials. Efficacy of DCB vs. POBA (plain old balloon angioplasty) in binary outcomes was investigated with relative risks and number needed to treat (NNT). Results Ten trials including 1835 patients and investigating six different DCB were identified. A high risk of bias was found in these studies. There was a lower Late Lumen Loss at six months and a higher FfTLR and primary patency at one year after DCB-treatment. However, results varied greatly with NNTs ranging from three to thirty-three. Overall, there were no differences in ABI- and Rutherford-Outcome as well as incidence of adverse events. Conclusion Tested DCBs were able to improve PTA results at one year. There were large differences in efficacy between different DCB. A class effect cannot be confirmed yet. There is a risk of overestimating the effect of DCBs due to the high risk of bias in the included trials.