Abstract Number: PB2461
Meeting: ISTH 2020 Congress
Theme: Venous Thromboembolism and Cardioembolism » VTE Treatment
Background: Edoxaban, a direct FXa inhibitor, is approved for the treatment and secondary prevention of acute venous thromboembolism (VTE). The efficacy and safety of edoxaban was evaluated in the randomized phase III trial Hokusai-VTE. ETNA-VTE-Europe is a prospective, single-arm, non-interventional, post-authorization safety study designed to confirm the real-world safety and effectiveness of edoxaban.
Aims: To assess patient characteristics and evaluate the rates and associations between the index VTE event (pulmonary embolism [PE] with or without deep vein thrombosis [DVT] versus DVT alone) and 12-month outcomes.
Methods: A total of 2407 patients with acute symptomatic VTE who were receiving edoxaban in routine practice were enrolled across eight European countries. Patients with an index event of PE with or without DVT (PE±DVT) were compared with those with an index event of DVT without PE.
Results: Patients with acute PE±DVT had a slightly higher age, a higher percentage of frailty, more hypertension and a more frequent history of PE than patients with DVT only (Table 1). The patients with DVT alone had more history of chronic venous insufficiency and an increased history of prior DVT. VTE recurrence was 2.83%, rates of any bleeding 13.00%, stroke rate 0.83% and all-cause mortality 3.37%. Patients with index PE±DVT had numerically higher rates of all-cause mortality (4.08% versus 2.85%), cardiovascular mortality (1.69% versus 1.21%) and major bleeding (2.39% versus 1.57%) rates than those with index DVT alone (Table 2). Table 1: Patien… Table 2. Clini…
Conclusions: Low rates of bleeding and VTE events were reported after 12 months of treatment with edoxaban in clinical practice. Patients with index PE with or without DVT reported a higher risk of mortality and bleeding events than those with index DVT alone.
Overall (N=2407) | PE±DVT (n=1004) | DVT alone (n=1403) | |
Female, n (%) | 1121 (46.6) | 485 (48.3) | 636 (45.3) |
Age (years), mean ± SD | 63.2 ± 15.87 | 64.4 ± 15.29 | 62.3 ± 16.23 |
Recalc. eGFR (Cockroft-Gault, mL/min), mean ± SD | 94.2 ± 38.97 | 92.8 ± 38.30 | 95.3 ± 39.47 |
Frailty (physician judgement), n (%) | 306 (12.7) | 140 (14.0) | 166 (11.8) |
Medical history, n (%) Hypertension Chronic venous insufficiency COPD Cancer Cancer still active* |
1041 (43.2) 264 (11.0) 162 (6.7) |
476 (47.4) 75 (7.5) 86 (8.6) |
565 (40.3) 189 (13.5) 76 (5.4) |
Prior VTE, n (%) Prior PE±DVT Prior DVT only |
177 (7.4) 388 (16.1) |
112 (11.2) 110 (11.0) |
65 (4.6) 278 (19.8) |
Edoxaban treatment at baseline, n (%) Edoxaban 60 mg Edoxaban 30 mg |
2100 (87.2) |
891 (88.7) |
1209 (86.2) |
*Percentage based on patients with cancer history. COPD, chronic obstructive pulmonary disease; DVT, deep vein thrombosis; eGFR, estimated glomerular filtration rate; PE, pulmonary embolism; SD, standard deviation; VTE, venous thromboembolism. |
[Table 1: Patient baseline characteristics according to type of index event 1-year follow-up analysis set [N=2407]]
Outcomes during 12-months follow-up, n (%) | Overall (N=2407) | PE±DVT (n=1004) | DVT alone (n=1403) |
Any VTE recurrences PE with or w/o DVT recurrence PE w/o DVT recurrence PE with DVT recurrence DVT only recurrence |
68 (2.83) 27 (1.12) 21 (0.87) 47 (1.95) |
29 (2.89) 17 (1.69) 13 (1.29) 16 (1.59) |
39 (2.78) 10 (0.71) 8 (0.57) 31 (2.17) |
Any bleeding ICH Major bleeding (ISTH) CRNM bleeding Major GI bleeding |
313 (13.00) 12 (0.50) 46 (1.91) 82 (3.41) 10 (0.42) |
149 (14.84) 10 (1.00) 24 (2.39) 38 (3.78) 4 (0.40) |
164 (11.69) 2 (0.14) 22 (1.57) 44 (3.14) 6 (0.43) |
Stroke or systemic embolism | 24 (1.00) | 11 (1.10) | 13 (0.93) |
All-cause mortality | 81 (3.37) | 41 (4.08) | 40 (2.85) |
CV mortality | 34 (1.41) | 17 (1.69) | 17 (1.21) |
CRNM, clinically relevant non-major; CV, cardiovascular; DVT, deep vein thrombosis; GI, gastrointestinal; ICH, intracranial hemorrhage; ISTH, International Society on Thrombosis and Haemostasis; PE, pulmonary embolism; VTE, venous thromboembolism. |
[Table 2. Clinical outcomes of patients enrolled in the ETNA-VTE-Europe study during 12-months follow-up according to type of index event (n=2407)]
To cite this abstract in AMA style:
Coppens M, Cohen AT, Ay C, Hainaut P, Hoffmann U, Gaine S, Jiménez D, Schindewolf M, Brüggenjürgen B, Levy P, López Bastida J, Vicaut E, Bramlage P, Agnelli G, ETNA-VTE-Europe Investigators . Association Between Index VTE Event and 12-Months Outcomes for Patients in Routine Clinical Practice Enrolled in the ETNA-VTE-Europe Registry [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/association-between-index-vte-event-and-12-months-outcomes-for-patients-in-routine-clinical-practice-enrolled-in-the-etna-vte-europe-registry/. Accessed October 1, 2023.« Back to ISTH 2020 Congress
ISTH Congress Abstracts - https://abstracts.isth.org/abstract/association-between-index-vte-event-and-12-months-outcomes-for-patients-in-routine-clinical-practice-enrolled-in-the-etna-vte-europe-registry/