A recent, large meta-analysis by Katsanos et al. published in the Journal of the American Heart Association reported a significant increased risk of all-cause death beginning 2 years after treatment for patients receiving a paclitaxel-coated balloon or stent in femoropopliteal arterial revascularization compared with patients receiving a device without the drug. The Food and Drug Administration has issued a letter to physicians regarding the reported concern noting that it is assessing the risk.

References

1. Katsanos K, Spiliopoulos S, Kitrou P, Krokidis M, Karnabatidis D. Risk of Death Following Application of Paclitaxel-Coated Balloons and Stents in the Femoropopliteal Artery of the Leg: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Am Heart Assoc 2018;7:e011245.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Interventions and Imaging, Angiography, Nuclear Imaging

Keywords: Angiography, Coronary Angiography, Stents, Paclitaxel, United States Food and Drug Administration, Femoral Artery, Risk

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