Data sources and applied methods for paclitaxel safety signal discernment.

Journal: Frontiers in cardiovascular medicine
Published Date: Feb 23, 2024

Abstract

BACKGROUND: Following the identification of a late mortality signal, the Food and Drug Administration (FDA) convened an advisory panel that concluded that additional clinical study data are needed to comprehensively evaluate the late mortality signal observed with the use of drug-coated balloons (DCB) and drug-eluting stent (DES). The objective of this review is to (1) identify and summarize the existing clinical and cohort studies assessing paclitaxel-coated DCBs and DESs, (2) describe and determine the quality of the available data sources for the evaluation of these devices, and (3) present methodologies that can be leveraged for proper signal discernment within available data sources.

Authors

  • Laura Elisabeth Gressler
    Office for Clinical Evidence and Analysis, United States Food and Drug Administration, Silver Spring, MD, United States.
  • Erika Avila-Tang
    Office for Clinical Evidence and Analysis, United States Food and Drug Administration, Silver Spring, MD, United States.
  • Jialin Mao
    Department of Population Health Sciences, Weill Cornell Medicine, New York, NY, United States.
  • Alejandra Avalos-Pacheco
    Applied Statistics Research Unit, Faculty of Mathematics and Geoinformation, TU Wien, Vienna, Austria.
  • Fadia T Shaya
    School of Pharmacy, University of Maryland Baltimore, Baltimore, MD, United States.
  • Yelizaveta Torosyan
    Office for Clinical Evidence and Analysis, United States Food and Drug Administration, Silver Spring, MD, United States.
  • Alexander Liebeskind
    Office for Clinical Evidence and Analysis, United States Food and Drug Administration, Silver Spring, MD, United States.
  • Madris Kinard
    Device Events, York, PA, United States.
  • Christina D Mack
    IQVIA Real World Solutions, Research Triangle Park, Raleigh, NC, United States.
  • Sharon-Lise Normand
    Department of Health Care Policy, Harvard Medical School, Boston, MA, United States.
  • Mary E Ritchey
    Med Tech Epi, Philadelphia, PA, United States.
  • Danica Marinac-Dabic
    Office for Clinical Evidence and Analysis, United States Food and Drug Administration, Silver Spring, MD, United States.

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