Off-label direct oral anticoagulants dosing in atrial fibrillation and venous thromboembolism is associated with higher mortality

Francisco Aguilar, Kevin B. Lo, Eduardo E. Quintero, Ricardo J. Torres, Wikien A. Hung, Jeri C. Albano, Isabella Alviz, Carlos Rodriguez, Mario J. Garcia, Jorge E. Romero, Leandro Slipczuk

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Direct oral anticoagulants (DOAC) off-label use data is lacking. Our study aimed to assess the clinical outcomes in a racially mixed population treated for atrial fibrillation (AF) and venous thromboembolism (VTE). Methods: We retrospectively evaluated six months of DOAC prescriptions for AF or VTE treatment. Prescriptions were classified as off-label or appropriate following FDA labeling. The off-label group was sub-classified as under or overdosing. Results: Of the 1,087 DOAC prescriptions, 67% were for AF. African Americans and Caucasians were equally represented. There were 171 (16%) inappropriate prescriptions, with 106 (62%), being underdosed. The off-label group had a higher 30-day readmissions risk (OR = 1.69, 95% CI:1.11–2.54, p = 0.012) and 1-year all-cause mortality (OR = 1.90, 95% CI:1.02–3.37, p = 0.032). There was no difference in major bleeding (OR = 1.27, 95% CI:0.63–2.37, p = 0.480) or new thromboembolism (OR = 1.27, 95% CI:0.73–2.13, p = 0.369) between the groups. Underdosing carried a higher risk of new thromboembolism (OR = 3.15, 95% CI:1.09–9.15, p = 0.024). Conclusions: One in every six patients received off-label DOACs dosing. Off-label use had increased 30-day readmissions and 1-year all-cause mortality. Underdosing was associated with a higher risk of new thromboembolism.

Original languageEnglish (US)
JournalExpert Review of Cardiovascular Therapy
DOIs
StateAccepted/In press - 2021

Keywords

  • Afib
  • DOAC
  • DVT
  • inappropriate
  • NOAC
  • PE

ASJC Scopus subject areas

  • Internal Medicine
  • Cardiology and Cardiovascular Medicine

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