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Peri-procedural Heparin Use in Patients Receiving Edoxaban: Analyses of the Noninterventional Global EMIT (Edoxaban Management in Diagnostic and Therapeutic Procedures) Study

A. Santamaria1, C. Chen2, C. Von Heymann3, T. Vanassche4, M. Saxena5, J. Jin2, M. Unverdorben2, P. Colonna6

1University Hospital Vall d'Hebron, Service of Haematology, Haemostasis and Thrombosis Unit, Barcelona, Spain, 2Daiichi Sankyo, Inc., Basking Ridge, United States, 3Vivantes Klinikum im Friedrichshain, Department of Anaesthesia & Intensive Care Medicine, Emergency Medicine, and Pain Therapy, Berlin, Germany, 4University Hospitals (UZ) Leuven, Department of Cardiovascular Sciences, Leuven, Belgium, 5Barts Health NHS Trust, NIHR CV BRC, London, United Kingdom, 6Polyclinic of Bari - Hospital, Department of Cardiology, Bari, Italy

Abstract Number: OC 46.1

Meeting: ISTH 2021 Congress

Theme: Coagulation and Natural Anticoagulants » Critical Care and Perioperative

Background: Bridging with low molecular weight heparin for periprocedural management of patients on direct oral anticoagulants undergoing invasive procedures is not supported by scientific evidence, and reports from real world practice addressing this topic are scant.

Aims: To describe and analyze periprocedural heparin use and clinical events in unselected, edoxaban-treated patients undergoing invasive procedures in routine clinical practice.

Methods: The prospective EMIT-AF/VTE study collected data on periprocedural management and clinical events in patients from Europe and Asia treated with edoxaban and undergoing diagnostic/therapeutic procedures, from 5 days pre- to 30 days post-procedure. Bridging was defined as heparin use during periprocedural period in lieu of edoxaban. The primary clinical event outcome was ISTH major bleeding (MB). Secondary outcomes included clinically relevant non-major bleeding (CRNMB) and acute thromboembolic events.

Results: In 1,619 patients, 2,155 procedures were performed, 94% in AF and 6% in VTE patients. Heparin bridging was used in 194 (9%) procedures. Patients with heparin bridging had higher CHA2DS2-VASc (3.6 ± 1.5 vs 3.2 ± 1.6) and HAS-BLED scores (2.4 ± 1.0 vs 1.8 ± 1.1) than those without bridging. Bridging was approximately 5 times more frequent in EHRA high bleeding risk procedures (24%; 120/502) than in low risk (5%; 48/998) and minor risk procedures (5%; 24/501) (Table 1).  MB/CRNMB were more frequent in procedures with heparin bridging (3.6%; 7/194) than in those without bridging (0.9%; 17/1961).  Ischemic stroke occurred in 0.5% (1/194) of procedures with heparin bridging and in 0.4% (7/1961) of procedures without bridging (Table 2).

Baseline characteristics Procedures without heparin bridging 
(n=1961)
Procedures with heparin bridging 
(n=194)
Age [years], Mean (SD) 71.8 (9.8) 72.2 (11.0)
Male, n (%) 1304 (66.5) 119 (61.3)
Weight [kg], Mean (SD) 77.8 (17.1) 80.8 (17.0)
Body Mass Index [kg/m2], Mean (SD) 27.3 (4.8) 27.7 (4.7)
Creatinine Clearance [mL/min], Mean (SD) 72.3 (30.4) 77.2 (33.2)
EHRA Bleeding Risk of Procedure, n (%)
      High 382 (19.5) 120 (61.9)
      Low 950 (48.4) 48 (24.7)
      Minor 477 (24.3) 24 (12.4)

Baseline characteristics by heparin bridgingEHRA = European Heart Rhythm Association

Clinical events Procedures without heparin bridging 
(n=1961)
Procedures with heparin bridging 
(n=194)
p-value
All Bleeding 55 (2.8%) 13 (6.7%) 0.003
MB or CRNMB 17 (0.9%) 7 (3.6%) 0.001
Acute coronary syndrome 0 1 (0.5%) 0.09
Ischemic Stroke 7 (0.4%) 1 (0.5%) 0.53
Transient ischemic attack 2 (0.1%) 0 1.00
Systemic embolic events 0 1 (0.5%) 0.09
Cardiovascular mortality 4 (0.2%) 1 (0.5%) 0.38
All-cause mortality 12 (0.6%) 2 (1.0%) 0.36

Clinical events by heparin bridging

Conclusions: Heparin bridging was uncommon in unselected patients treated with edoxaban and undergoing invasive procedures in routine clinical practice. Bridging was more frequent in EHRA high bleeding risk procedures, was associated with more MB/CRNMB, but did not influence the incidence of acute thromboembolic events.

To cite this abstract in AMA style:

Santamaria A, Chen C, Von Heymann C, Vanassche T, Saxena M, Jin J, Unverdorben M, Colonna P. Peri-procedural Heparin Use in Patients Receiving Edoxaban: Analyses of the Noninterventional Global EMIT (Edoxaban Management in Diagnostic and Therapeutic Procedures) Study [abstract]. Res Pract Thromb Haemost. 2021; 5 (Suppl 2). https://abstracts.isth.org/abstract/peri-procedural-heparin-use-in-patients-receiving-edoxaban-analyses-of-the-noninterventional-global-emit-edoxaban-management-in-diagnostic-and-therapeutic-procedures-study/. Accessed September 29, 2023.

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