Abstract
A systemic review and meta-analysis analyzed randomized controlled trials using PubMed (MEDLINE), Embase (Excerpta Medica Database), Allied and Complementary Medicine Database, Scopus, Cochrane Central Register of Controlled Trials, archived online content, public filings of regulatory bodies, and published abstracts from international vascular meetings through August 2018. In 28 randomized controlled trials, 4663 patients underwent paclitaxel-coated balloon angioplasty and stenting of the femoropopliteal (FP) artery. All-cause patient death at 2 years (7% vs 4%) and 5 years (15% vs 8%) was significantly higher in paclitaxel-coated devices compared with control arms. Meta-regression analysis showed a significant relationship between exposure to paclitaxel and absolute risk of death (P < .001). There is increased risk of death after application of paclitaxel-coated balloons and stents in FP arteries.
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