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Safety of Paclitaxel Coated Devices: Is the Quest Completed?

Published:August 31, 2022DOI:https://doi.org/10.1016/j.ejvs.2022.08.030
      In this linked registry claims study (Vascular Quality Initiative registry and Medicare claims data), Mao et al. report the outcomes of 11 452 patients with femoropopliteal atherosclerotic disease treated with either paclitaxel coated devices (PCD) or non-PCD.
      • Mao J.
      • Sedrakyan A.
      • Goodney P.P.
      • Malone M.
      • Cavanaugh K.J.
      • Marinac-Dabic D.
      • et al.
      Real-world study of mortality after the use of paclitaxel-coated devices in peripheral vascular intervention.
      The primary outcome was all cause mortality and the secondary outcome was major amputation within three years after the index intervention. The treatment effect was analysed using inverse probability weighting (IPW). In order to identify differential effects and increase the understanding of previous conflicting results, the authors created three subgroups: (A) patients treated for femoropopliteal or infrapopliteal occlusive disease with or without any other concurrent treatment; (B) patients treated for isolated superficial femoral or popliteal artery disease; and (C) patients with inclusion criteria designed to approximate randomised clinical trial (RCT) populations. In this large and robust study based on real world data, with very few missing and a low dropout rate, the authors did not observe increased all cause mortality (even a potential protective effect) or major amputation at three years after the intervention with PCD in any of the groups.
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