The Safety and Effectiveness of Warfarin Vs Apixaban in Patients with NVAF/ VTE and ESKD on Dialysis (WARD)

Abu Dhabi Health Services Company

Status: Completed

Conditions: Venous Thromboembolism (VTE); End-Stage Kidney Disease (ESKD); Non-valvular Atrial Fibrillation (NVAF)

Treatments: Drug: Apixaban; Drug: Warfarin

Study type: Observational

Funder types: Other

Identifiers

NCT06606275

KD/AJ/1063

Details and patient eligibility

About

This is a retrospective study of End-Stage Kidney Disease (ESKD) patients on dialysis receiving apixaban or warfarin at Tawam Hospital [a tertiary care hospital in Al Ain, UAE]. The study aims to assess the appropriateness of prescribing apixaban and warfarin in this population and evaluate their safety and effectiveness.

Full description

Direct oral anticoagulants (DOACs), including apixaban, are used for stroke prevention in non-valvular atrial fibrillation (NVAF) and for venous thromboembolism (VTE) management. Patients with end-stage kidney disease (ESKD) on dialysis face elevated risks of thromboembolic events and bleeding. While apixaban is FDA-approved for use in this population, its safety and efficacy compared to warfarin are not well established in this vulnerable population.

This retrospective observational study aims to assess the prescribing appropriateness of apixaban compared to warfarin and evaluate their safety and effectiveness in a cohort of ESKD patients undergoing dialysis. This study will include ESKD patients on dialysis receiving apixaban or warfarin at Tawam Hospital from May 1, 2018, to January 31, 2024. Data on demographics, anticoagulant dosing, therapy duration, bleeding events, CHA2DS2-VASc score, HAS-BLED score, and thromboembolic events will be collected. Safety will be assessed by bleeding incidents, and effectiveness will be measured by VTE and stroke events. Dose appropriateness was evaluated according to FDA guidelines for apixaban and INR targets for warfarin. Data will be collected for eligible patients through electronic medical records (EMR).

Enrollment: 67 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age more than 18
• CKD on dialysis for at least 1 month
• NVAF or VTE
• On Apixaban or Warfarin for at least 1 month

Exclusion criteria

• Age less than 18
• Received dialysis for less than 1 month (i.e., were treated with dialysis for acute kidney injury).
• On Apixaban or Warfarin for less than 1 month
• Pregnancy

Trial design

67 participants in 2 patient groups

Apixaban arm

Description:

Patient who were receiving warfarin while on dialysis

Treatment:

Drug: Apixaban

Warfarin arm

Description:

Patient who were receiving warfarin while on dialysis

Treatment:

Drug: Warfarin