Predictive Factors and Clinical Events Associated with Edoxaban Interruption and Heparin Bridging Strategy: EMIT-AF/VTE

Author:

Santamaria Amparo1ORCID,Chen Cathy2,Colonna Paolo3,von Heymann Christian4,Saxena Manish5,Vanassche Thomas6,Jin James2,Unverdorben Martin2

Affiliation:

1. Hematology Department, University Hospital Vinalopó, Alicante, Spain

2. Global Specialty Medical Affairs, Daiichi Sankyo, Inc., Basking Ridge, NJ, USA

3. Department of Cardiology, Polyclinic of Bari - Hospital, Bari, Italy

4. Department of Anaesthesia, Intensive Care Medicine, Emergency Medicine, and Pain Therapy, Vivantes Klinikum im Friedrichshain, Berlin, Germany

5. Barts NIHR Cardiovascular Biomedical Research Centre, London, UK

6. Department of Cardiovascular Sciences, University Hospitals (UZ) Leuven, Leuven, Belgium

Abstract

Patients treated with edoxaban may require diagnostic and therapeutic procedures that involve edoxaban interruption. Although heparin bridging strategies are not recommended, heparin is frequently used in clinical practice. However, whether heparin use decreases thromboembolic risk remains unclear, and the potential for increased periprocedural bleeding remains a concern. Here, we report factors predicting edoxaban interruption and the use of heparin bridging strategies and associated clinical events from Global EMIT-AF/VTE, a multicenter, prospective, noninterventional study (Clinicaltrials.gov NCT02950168). Eligible patients are adults with atrial fibrillation or venous thromboembolism treated with edoxaban who underwent a diagnostic or therapeutic procedure. Edoxaban interruption, heparin bridging strategies, and clinical event data were collected from 5 days before procedure through 29 days afterwards. Edoxaban was interrupted in 1222/2089 procedures (58.5%); a heparin bridging strategy was used during 178 (14.6%) of these interruptions. Patients who received periprocedural heparin had higher baseline HAS-BLED (2.4±1.0 vs 1.9±1.1, P <0.0001) scores and similar CHA2DS2-VASc (3.6±1.6 vs 3.4±1.6, P = 0.09) scores versus patients who did not. HAS-BLED score >3 and high EHRA procedural risk predicted both edoxaban interruption and the use of a heparin bridging strategy, whereas CHA2DS2-VASc scores did not predict either. Bleeding and ischemic event rates were low; the all-bleeding rate was higher with the use of a heparin bridging strategy versus without (6.2% vs 3.1%, P = 0.04). Periprocedural heparin use was associated with higher bleeding rates, but not with lower thromboembolic risk. Individual patient and procedural bleeding risks appear to contribute more than stroke risk to clinicians’ consideration of a heparin bridging strategy.

Funder

Daiichi Sankyo, Inc

Publisher

SAGE Publications

Subject

Hematology,General Medicine

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