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Practice Guideline
. 2023 Nov;78(5):1313-1321.
doi: 10.1016/j.jvs.2023.07.050. Epub 2023 Jul 29.

Consensus minimum core data elements adapted to peripheral vascular intervention in the drug-eluting era: Consensus report from the Registry Assessment of Peripheral Interventional Devices (RAPID) Pathways "LEAN" working group

James H Black 3rd  1 , Donna Buckley  2 , Martha Velezis  2 , Jens Eldrup-Jorgensen  3 , Nina D Serratore  4 , Jorge A Gutierrez  5 , Eleni Whatley  2 , Rebecca A Marmor  6 , Daniel J Bertges  7 , James E Tcheng  5 , Sara Royce  2 , Misti Malone  2 , Andrew Farb  2 , Eric A Secemsky  8 , Sahil A Parikh  9 , Joshua Smale  10 , Michael R Jaff  11 , Roseann White  12 , Rebecca W Wilgus  5 , Mitchell W Krucoff  5
Affiliations
Practice Guideline

Consensus minimum core data elements adapted to peripheral vascular intervention in the drug-eluting era: Consensus report from the Registry Assessment of Peripheral Interventional Devices (RAPID) Pathways "LEAN" working group

James H Black 3rd et al. J Vasc Surg. 2023 Nov.

Abstract

Registry Assessment of Peripheral Interventional Devices (RAPID) initiated the Pathways Program to provide a transparent, collaborative forum in which to pursue insights into multiple unresolved questions on benefit-risk of paclitaxel-coated devices, including understanding the basis of the mortality signal, without a demonstrable potential biological mechanism, and whether the late mortality signal could be artifact intrinsic to multiple independent prospective randomized data sources that did not prespecify death as a long-term end point. In response to the directive, the LEAN-Case Report Form working group focused on enhancements to the RAPID Phase I Minimum Core Data set through the addition of key clinical modifiers that would be more strongly linked to longer-term mortality outcomes after peripheral arterial disease intervention in the drug-eluting device era, with the goal to have future mortality signals more accurately examined.

Keywords: PAD; Paclitaxel; RAPID.

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Conflict of interest statement

The editors and reviewers of this article have no relevant financial relationships to disclose per the JVS policy that requires reviewers to decline review of any manuscript for which they may have a conflict of interest.

Figures

Fig 1.
Fig 1.
Phases of Registry Assessment of Peripheral Interventional Devices (RAPID) activity. MCDE, mulitple CDE; PVI, peripheral vascular intervention.
Fig 2.
Fig 2.
Covariate poll results for mortality. SAP, Statistical analysis plan.
See this image and copyright information in PMC

References

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