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%) |
1173 (69.3%) |
541 (57.7%) |
693 (54.2%) |
||
Type of index VTE event, n (%) DVT PE with DVT PE w/o DVT |
2227 (57.0%) |
1000 (59.1%) |
500 (53.3%) |
727 (56.9%) |
||
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.« Back to ISTH 2020 Congress
ISTH Congress Abstracts - 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/