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.

Autor:	Black JH 3rd; Johns Hopkins University School of Medicine, Baltimore, MD. Electronic address: jhblack@jhmi.edu., Buckley D; Office of Cardiovascular Devices, Food and Drug Administration, Silver Spring, MD., Velezis M; Office of Cardiovascular Devices, Food and Drug Administration, Silver Spring, MD., Eldrup-Jorgensen J; Society of Vascular Surgery Patient Safety Organization, Chicago, IL., Serratore ND; Cook Research, Inc, West Lafayette, IN., Gutierrez JA; Duke University Medical Center/Duke Clinical Research Institute, Durham, NC., Whatley E; Office of Cardiovascular Devices, Food and Drug Administration, Silver Spring, MD., Marmor RA; Johns Hopkins University School of Medicine, Baltimore, MD., Bertges DJ; University of Vermont Medical Center, Burlington, VT., Tcheng JE; Duke University Medical Center/Duke Clinical Research Institute, Durham, NC., Royce S; Office of Cardiovascular Devices, Food and Drug Administration, Silver Spring, MD., Malone M; Office of Cardiovascular Devices, Food and Drug Administration, Silver Spring, MD., Farb A; Office of Cardiovascular Devices, Food and Drug Administration, Silver Spring, MD., Secemsky EA; Smith Center for Outcomes Research, Beth Israel Deaconess Medical Center, Boston, MA., Parikh SA; Columbia University Irving Medical Center, New York, NY., Smale J; Becton, Dickinson and Company, Franklin Lakes, NJ., Jaff MR; Boston Scientific, Corporation, Inc, Marlborough, MA., White R; Syntactx, New York, NY., Wilgus RW; Duke University Medical Center/Duke Clinical Research Institute, Durham, NC., Krucoff MW; Duke University Medical Center/Duke Clinical Research Institute, Durham, NC.
Jazyk:	angličtina
Zdroj:	Journal of vascular surgery [J Vasc Surg] 2023 Nov; Vol. 78 (5), pp. 1313-1321. Date of Electronic Publication: 2023 Jul 29.
DOI:	10.1016/j.jvs.2023.07.050
Abstrakt:	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. (Copyright © 2023 Society for Vascular Surgery. All rights reserved.)
Databáze:	MEDLINE
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