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Important considerations for trials for peripheral arterial disease: Lessons learned from the paclitaxel mortality signal: A report on behalf of the registry assessment for peripheral interventional Devices (RAPID) Paclitaxel Pathways Program.

Publication ,  Journal Article
Lottes, AE; Whatley, EM; Royce, SM; Bertges, DJ; Erickson, CA; Farb, A; Fox, ML; Jiang, JH; Wang, L; Lin, AY; Malone, ML; Papandreou, G ...
Published in: Am Heart J
February 2021

The Registry Assessment of Peripheral Devices (RAPID) convened a multidisciplinary group of stakeholders including clinicians, academicians, regulators and industry representatives to conduct an in-depth review of limitations associated with the data available to assess the paclitaxel mortality signal. Available studies were evaluated to identify strengths and limitations in the study design and data quality, which were translated to lessons learned to help guide the design, execution, and analyses of future studies. We suggest numerous actionable responses, such as the development and use of harmonized data points and outcomes in a consensus lean case report form. We advocate for reduction in missing data and efficient means for accrual of larger sample sizes in Peripheral arterial disease studies or use of supplemental datasets. Efforts to share lessons learned and working collaboratively to address such issues may improve future data in this device area and ultimately benefit patients. Condensed Abstract: Data sources evaluating paclitaxel-coated devices were evaluated to identify strengths and limitations in the study design and data quality, which were translated to lessons learned to help guide the design, execution, and analyses of future studies. We suggest numerous actionable responses, which we believe may improve future data in this device area and ultimately benefit patients.

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Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

February 2021

Volume

232

Start / End Page

71 / 83

Location

United States

Related Subject Headings

  • Tubulin Modulators
  • Stents
  • Risk Assessment
  • Reproducibility of Results
  • Randomized Controlled Trials as Topic
  • Popliteal Artery
  • Peripheral Arterial Disease
  • Paclitaxel
  • Mortality
  • Meta-Analysis as Topic
 

Citation

APA
Chicago
ICMJE
MLA
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Lottes, A. E., Whatley, E. M., Royce, S. M., Bertges, D. J., Erickson, C. A., Farb, A., … Krucoff, M. W. (2021). Important considerations for trials for peripheral arterial disease: Lessons learned from the paclitaxel mortality signal: A report on behalf of the registry assessment for peripheral interventional Devices (RAPID) Paclitaxel Pathways Program. Am Heart J, 232, 71–83. https://doi.org/10.1016/j.ahj.2020.10.070
Lottes, Aaron E., Eleni M. Whatley, Sara M. Royce, Daniel J. Bertges, Carla A. Erickson, Andrew Farb, Megan L. Fox, et al. “Important considerations for trials for peripheral arterial disease: Lessons learned from the paclitaxel mortality signal: A report on behalf of the registry assessment for peripheral interventional Devices (RAPID) Paclitaxel Pathways Program.Am Heart J 232 (February 2021): 71–83. https://doi.org/10.1016/j.ahj.2020.10.070.
Lottes AE, Whatley EM, Royce SM, Bertges DJ, Erickson CA, Farb A, Fox ML, Jiang JH, Wang L, Lin AY, Malone ML, Papandreou G, Wilgus RW, Rosenfield K, Krucoff MW. Important considerations for trials for peripheral arterial disease: Lessons learned from the paclitaxel mortality signal: A report on behalf of the registry assessment for peripheral interventional Devices (RAPID) Paclitaxel Pathways Program. Am Heart J. 2021 Feb;232:71–83.
Journal cover image

Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

February 2021

Volume

232

Start / End Page

71 / 83

Location

United States

Related Subject Headings

  • Tubulin Modulators
  • Stents
  • Risk Assessment
  • Reproducibility of Results
  • Randomized Controlled Trials as Topic
  • Popliteal Artery
  • Peripheral Arterial Disease
  • Paclitaxel
  • Mortality
  • Meta-Analysis as Topic