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Edoxaban Treatment of Venous Thromboembolism in Routine Clinical Practice in the Non-Interventional Global ETNA-VTE Program: A Sub-Analysis by Age Groups

1University of Perugia, Internal and Cardiovascular Medicine-Stroke Unit, Perugia, Italy, 2Nakamura Medical Clinic, Department of Internal Medicine, Pediatrics and Cardiology, Kuwana, Japan, 3Far Eastern Memorial Hospital, Cardiovascular Center, New Taipei City, Taiwan, Republic of China, 4Yuan Ze University, Electrical Engineering, Taoyuan, Taiwan, Republic of China, 5Hanyang University Myongji Hospital, Department of Internal Medicine, Goyang-si, Korea, Republic of, 6Daiichi Sankyo Europe GmbH, Clinical Operations and Biostatistics and Data Operations, Munich, Germany, 7Daiichi Sankyo, Inc., Global Medical Affairs, Basking Ridge, United States, 8Guy's and St Thomas' NHS Foundation Trust, King's College London, London, United Kingdom

Abstract Number: PB2409

Meeting: ISTH 2020 Congress

Theme: Venous Thromboembolism and Cardioembolism » VTE Treatment

Background: Edoxaban is approved for treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE. The non-interventional, global ETNA-VTE program, conducted in Asia and Europe, investigates safety and effectiveness of edoxaban in unselected VTE patients in routine clinical practice.

Aims: Baseline patient characteristics and clinical events at 1-year follow up are reported for overall study population and by age groups.

Methods: This study enrolled patients with acute DVT and/or PE for whom edoxaban was initiated as part of routine clinical care. All patients provided written informed consent, and the study was approved by responsible Ethic Committees and/or Institutional Review Boards. Data were collected at baseline and during 12-month follow-up.

Results: Among the 3,908 patients, mean age was 64.9 ± 15.50 years; 43.3% of patients were ≤65 years, 24% were ≥65 to < 75 years, and 32.7% were ≥75 years old. Mean body weight and creatinine clearance, and the proportion of male gender were lower with advanced age. Thus, the percentage of patients on 60 mg edoxaban once daily was lower with advanced age (Table 1). With increasing age, DVT and PE recurrences trended towards lower incidences whereas major bleeding events trended higher. Total mortality was higher with advanced age and was not driven by cardiovascular mortality (Table 2).

Conclusions: VTE recurrences occurred less frequently and bleeding occurred more frequently in older patients. In routine clinical practice, edoxaban treatment for VTE demonstrated effectiveness and safety across all age groups.

  Overall
[N=3908]		 Age < 65 years [N=1692] Age in
[65; 75) years [N=938]		 Age ≥ 75 years [N=1278]
Age, years, mean ± SD 64.9 ± 15.50 50.1 ± 10.52 69.6 ± 2.86 81.0 ± 4.51
Male, n (%) 1900 (48.6%) 949 (56.1%) 444 (47.3%) 507 (39.7%)
Weight, kg, mean ± SD 73.6 ± 19.05 79.7 ± 19.72 72.9 ± 18.09 66.3 ± 15.92
eGFR (Cockcroft-Gault), ml/min, mean ± SD 88.2 ± 38.44 115.7 ± 36.46 80.8 ± 25.72 58.4 ± 19.03
Geographic region,
n (%)
Europe
Japan
South Korea /Taiwan

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

1173 (69.3%)
428 (25.3%)
91 (5.4%)

541 (57.7%)
338 (36.0%)
59 (6.3%)

693 (54.2%)
488 (38.2%)
97 (7.6%)

Type of index VTE event, n (%)
DVT
PE with DVT
PE w/o DVT

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

1000 (59.1%)
400 (23.6%)
292 (17.3%)

500 (53.3%)
226 (24.1%)
212 (22.6%)

727 (56.9%)
311 (24.3%)
240 (18.8%)
Medical history, n (%)
Hypertension
Diabetes mellitus
Dys-/hyperlipidemia
COPD
Major surgery or trauma
Bleeding history
Major or CRNM bleeding
Major bleeding
Major GI bleeding
Ischemic stroke
1713 (43.8%)
506 (12.9%)
849 (21.7%)
218 (5.6%)
559 (14.3%)
175 (4.5%)
124 (3.2%)
80 (2.0%)
12 (0.3%)
156 (4.0%)
404 (23.9%)
134 (7.9%)
233 (13.8%)
45 (2.7%)
266 (15.7%)
59 (3.5%)
42 (2.5%)
25 (1.5%)
4 (0.2%)
25 (1.5%)
489 (52.1%)
154 (16.4%)
231 (24.6%)
59 (6.3%)
129 (13.8%)
49 (5.2%)
34 (3.6%)
24 (2.6%)
5 (0.5%)
39 (4.2%)
820 (64.2%)
218 (17.1%)
385 (30.1%)
114 (8.9%)
164 (12.8%)
67 (5.2%)
48 (3.8%)
31 (2.4%)
3 (0.2%)
92 (7.2%)
Edoxaban 60 mg at
baseline, n (%)		 2716 (69.5%) 1433 (84.7%) 622 (66.3%) 661 (51.7%)

[Tab. 1: Baseline characteristics]

Events during 12-months follow-up, n (%/year) Overall
[N=3908]		 Age < 65 years [N=1692] Age in
[65; 75) years
[N=938]		 Age ≥ 75 years
[N=1278]
VTE recurrence
DVT only
PE with or w/o DVT
PE w/o DVT
PE with DVT
 111 (3.45)
77 (2.38)
44 (1.36)
37 (1.14)
7 (0.21)		 62 (4.23)
43 (2.92)
26 (1.75)
19 (1.28)
7 (0.47)		 26 (3.37)
19 (2.45)
9 (1.16)
9 (1,16)
0 (0.00)		 23 (2.35)
15 (1.53)
9 (0.92)
9 (0.92)
0 (0.00)
All−cause mortality
CV mortality		 198 (6.07)
37 (1.13)		 54 (3.61)
7 (0.47)		 49 (6.28)
10 (1.28)		 95 (9.63)
20 (2.03)
Any bleeding
Major bleeding [ISTH]
ICH
Major GI bleeding
CRNM bleeding
459 (15.42)
83 (2.57)
20 (0.61)
23 (0.71)
123 (3.86)		 196 (14.40)
22 (1.48)
4 (0.27)
2 (0.13)
54 (3.70)		 107 (14.91)
25 (3.24)
4 (0.51)
10 (1.29)
23 (2.99)		 156 (17.49)
36 (3.70)
12 (1.22)
11 (1.12)
46 (4.80)
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.

[Tab. 2: Clinical events by age during 12-month follow-up]

To cite this abstract in AMA style:

Agnelli G, Nakamura M, Chiu K-, Choi W-, Reimitz P, Chen C, Unverdorben M, Cohen A. Edoxaban Treatment of Venous Thromboembolism in Routine Clinical Practice in the Non-Interventional Global ETNA-VTE Program: A Sub-Analysis by Age Groups [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/edoxaban-treatment-of-venous-thromboembolism-in-routine-clinical-practice-in-the-non-interventional-global-etna-vte-program-a-sub-analysis-by-age-groups/. Accessed November 30, 2023.

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