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) |
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| 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%) |
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| Type of index VTE event, n (%) PE w/o DVT PE with DVT DVT |
744 (19.0%) |
423 (21.2%) |
283 (18.0%) |
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| 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%) |
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| 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. |
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[Baseline characteristics by bleeding risk by VTE-BLEED score]
| Events, n (%)/year | Overall | Low bleeding risk (n = 1994) |
High bleeding risk (n = 1575) |
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| 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) |
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| All−cause mortality CV mortalitya |
198 (6.07) 37 (1.13) |
38 (2.11) 12 (0.67) |
153 (13.19) 23 (1.98) |
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| 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) |
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| 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. |
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[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.« Back to ISTH 2020 Congress
ISTH Congress Abstracts - 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/