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ETNA-VTE Global: Evaluation of Bleeding Risk Based on VTE-BLEED Score on 12-month Outcomes in a Population Treated with Edoxaban

A. Cohen1, M. Unverdorben2, C. Chen2, P. Reimitz3, D. Jiménez4,5, G. Agnelli6

1Guy's and St Thomas' NHS Foundation Trust, King's College London, London, United Kingdom, 2Daiichi Sankyo, Inc., Global Medical Affairs, Basking Ridge, United States, 3Daiichi Sankyo Europe GmbH, Clinical Operations and Biostatistics and Data Operations, Munich, Germany, 4University of Alcalá, Madrid, Spain, 5Ramon y Cajal Hospital, Madrid, Spain, 6University of Perugia, Internal and Cardiovascular Medicine‐Stroke Unit, Perugia, Italy

Abstract Number: PB2478

Meeting: ISTH 2020 Congress

Theme: Venous Thromboembolism and Cardioembolism » VTE Treatment

Background: Venous thromboembolism (VTE) is the third most common cardiovascular (CV) condition. Edoxaban has been approved for the treatment and secondary prevention of VTE. Relevant to clinical practice is the understanding of safety and effectiveness of oral anticoagulation treatment relative to the bleeding risk of the patient.

Aims: To investigate outcomes in VTE patients treated with edoxaban categorised into low or high bleeding risk using the VTE-BLEED Score (active cancer, anemia, age ≥60 years, male with SBP ≥140 mmHg, eGFR < 60 ml/min, history of CRNMB).

Methods: Patients with acute symptomatic VTE who received edoxaban were recruited across eight European and three Asian countries. Patients were divided into two bleeding risk categories low or high (VTE-BLEED Scores < 2 or ≥ 2) and followed for safety (bleeding) and effectiveness (VTE) events for 12 months.

Results: Of 3908 patients, 1994 (51%) had low, 1575 (40.3%) had high, and 339 (8.7%) had unknown bleeding risk (due to incomplete data). The proportion of high bleeding risk patients, who were generally older, had lower body weight, lower creatinine clearance and more comorbidities, was highest in Japan with 723/1245 (57.5%) followed by Korea/Taiwan 107/247 (43.3%) and Europe 745/2407 (30.9%) (Table 1). All categories of bleeding events, all-cause mortality and CV mortality were higher in the high-risk group compared with the low risk group, with approximately a 3-fold difference in major bleeding. The frequency of recurrent VTE and its components PE and DVT, were similar (Table 2).

Conclusions: In VTE patients on edoxaban, the results show that high vs low bleeding risk as identified by the VTE-BLEED score is associated with similar VTE recurrence risk but higher all-cause and cardiovascular mortality and higher incidences of any bleeding type or category.

  Overall Low
bleeding risk
(n = 1994)
High
bleeding risk
(n = 1575)
Female, n (%) 2008 (51.4%) 1082 (54.3%) 811 (51.5%)
Age, years, mean ± SD 64.9 ± 15.50 58.4 ± 15.12 74.2 ± 10.58
Weight, kg, mean ± SD 73.6 ± 19.05 78.4 ± 18.93 66.5 ± 17.15
Creatinine clearance (CG), ml/min,
mean ± SD
88.2 ± 38.44 104.7 ± 35.30 65.7 ± 30.69
Geographic region, n (%)
Europe
Japan
South Korea/Taiwan

2407 (61.6%)
1254 (32.1%)
247 (6.3%)

1412 (70.8%)
458 (23.0%)
124 (6.2%)

745 (47.3%)
723 (45.9%)
107 (6.8%)
Type of index
VTE event, n (%)

PE w/o DVT
PE with DVT
DVT

744 (19.0%)
937 (24.0%)
2227 (57.0%)

423 (21.2%)
503 (25.2%)
1068 (53.6%)

283 (18.0%)
402 (25.5%)
890 (56.5%)

Medical history, n (%)
Hypertension
Diabetes mellitus
Dyslipidemia
COPD
Major surgery or trauma
Malignancya
Bleeding history
Major or CRNM bleeding
Major bleeding
Major GI bleeding

1713 (43.8%)
506 (12.9%)
849 (21.7%)
218 (5.6%)
559 (14.3%)
449 (11.5%)
175 (4.5%)
124 (3.2%)
80 (2.0%)
12 (0.3%)

727 (36.5%)
231 (11.6%)
367 (18.4%)
87 (4.4%)
308 (19.0%)
0 (0.0%)
36 (1.8%)
13 (0.7%)
6 (0.35%)
2 (0.1%)

875 (55.6%)
246 (15.6%)
427 (27.1%)
125 (7.9%)
206 (21.7%)
449 (28.5%)
137 (8.7%)
109 (6.9%)
72 (4.6%)
10 (0.6%)
Edoxaban 60 mg at baseline, n (%) 2716 (69.5%) 1659 (83.2%) 760 (48.3%)
a active at enrolment
Abbreviations: BMI, body mass index; CG, Cockcroft-Gault; COPD, chronic obstructive pulmonary disease; CRNM, clinically relevant nonmajor; DVT, deep vein thrombosis; GI, gastrointestinal; PE, pulmonary embolism; SD, standard deviation; VTE, venous thromboembolism.

[Baseline characteristics by bleeding risk by VTE-BLEED score]

Events, n (%)/year Overall Low
bleeding risk
(n = 1994)
High
bleeding risk
(n = 1575)
VTE recurrence
PE with or w/o DVT
PE w/o DVT
PE with DVT
DVT only
111 (3.45)
44 (1.36)
37 (1.14)
7 (0.21)
77 (2.38)
58 (3.26)
23 (1.28)
16 (0.89)
7 (0.39)
42 (2.35)
44 (3.85)
18 (1.56)
18 (1.56)
0 (0.00)
29 (2.52)
All−cause mortality
CV mortalitya
198 (6.07)
37 (1.13)
38 (2.11)
12 (0.67)
153 (13.19)
23 (1.98)
Any bleeding
Major bleeding [ISTH]
ICH bleeding
Major GI bleeding
CRNM bleeding
459 (15.42)
83 (2.57)
20 (0.61)
23 (0.71)
123 (3.86)
223 (13.56)
27 (1.51)
6 (0.33)
5 (0.28)
56 (3.17)
209 (19.86)
51 (4.46)
10 (0.87)
18 (1.56)
58 (5.14)
asensitivity analysis
Abbreviations: CRNM, clinically relevant nonmajor; CV, cardiovascular; DVT, deep vein thrombosis; GI, gastrointestinal; ICH, intracranial haemorrhage; ISTH, International Society on Thrombosis and Haemostasis; PE, pulmonary embolism; VTE, venous thromboembolism.

[Clinical events during 12-month follow-up by VTE-BLEED score]

To cite this abstract in AMA style:

Cohen A, Unverdorben M, Chen C, Reimitz P, Jiménez D, Agnelli G. ETNA-VTE Global: Evaluation of Bleeding Risk Based on VTE-BLEED Score on 12-month Outcomes in a Population Treated with Edoxaban [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/etna-vte-global-evaluation-of-bleeding-risk-based-on-vte-bleed-score-on-12-month-outcomes-in-a-population-treated-with-edoxaban/. Accessed June 6, 2023.

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