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Cutaneous Small-Vessel Vasculitis following Dabigatran, Rivaroxaban, and Apixaban Use in Patients with Atrial Fibrillation: A Propensity Score Matched Analysis

Basic Details
Date Posted
Status
Complete
Medical Product
apixaban
dabigatran
direct oral anticoagulant (DOAC)
rivaroxaban
warfarin
Health Outcome(s)
cutaneous small-vessel vasculitis
Description

This analysis investigates the risk of cutaneous small-vessel vasculitis (CSVV) associated with the use of dabigatran, rivaroxaban, apixaban, and warfarin among patients with atrial fibrillation in the Sentinel Distributed Database (SDD).

The study period includes data from October 19, 2010 to February 29, 2020. We distributed this request to 16 Data Partners on September 15, 2020.

The analytic package associated with this analysis can be found externally in Sentinel's Git Repository located here. The Git Repository serves as Sentinel's version control tracking system for analytic packages and technical documentation.

Deliverables (2)
Sentinel Analytic Package: Cutaneous Small-Vessel Vasculitis following Dabigatran, Rivaroxaban, and Apixaban Use in Patients with Atrial Fibrillation: A Propensity Score Matched Analysis Sentinel Modular Program Report: Cutaneous Small-Vessel Vasculitis following Dabigatran, Rivaroxaban, and Apixaban Use in Patients with Atrial Fibrillation: A Propensity Score Matched Analysis
Additional Details
FDA Center
CDER
Time Period
October 19, 2010 - February 29, 2020
Analysis Type
Retrospective Inferential
Population / Cohort
Individuals 21 to 99 years of age
Data Sources
Sentinel Distributed Database (SDD)
Related Links
Cutaneous Small-Vessel Vasculitis Algorithm Defined in "Cutaneous Small-Vessel Vasculitis following Dabigatran, Rivaroxaban, and Apixaban Use: A Propensity Score Matched Analysis"
Cutaneous Small-Vessel Vasculitis following Direct Oral Anticoagulants (DOACs), Warfarin, or Allopurinol Use in Patients with Atrial Fibrillation: A Descriptive Analysis
Sentinel Drug Study: Eliquis (Apixaban), Pradaxa (Dabigatran), and Xarelto (Rivaroxaban) & Cutaneous Small-Vessel Vasculitis