Abstract Number: PB2434
Meeting: ISTH 2020 Congress
Theme: Venous Thromboembolism and Cardioembolism » VTE Treatment
Background: Edoxaban, a direct oral anticoagulant inhibiting FXa, has proven its efficacy and safety in the ENGAGE AF-TIMI 48 and Hokusai-VTE clinical trials. Clinical practice patients, however, may differ from those of clinical trials.
Aims: Using an observational study design, we aimed to compare Hokusai-VTE patients with those treated in clinical practice, and expand the knowledge about edoxaban’s clinical effectiveness and safety in the treatment and prevention of venous thromboembolism (VTE).
Methods: ETNA-VTE-Europe is a prospective, non-interventional post-authorisation safety study conducted in eight European countries.
Results: A total of 2,879 patients presenting with acute VTE (median age 65 years, 46.5% female) were enrolled at 339 sites (133 office-based physicians and 206 hospitals). Of the 2,680 patients with complete data, 23.6% reported prior VTE and 2.8% had a history of bleeding.
Patients in ETNA-VTE were older (65 vs. 57 years), more likely to be female (46.5 vs. 39.8%) and had a higher prevalence of chronic venous insufficiency (11.1 vs. 1.6%) than in the European cohort of the Hokusai-VTE clinical trial (n=1,512). Body weight and creatinine clearance were substantially lower in clinical practice with more patients having a bodyweight ≤60 kg (9.3% vs. 5.6%) and a CrCl ≤50 ml/min (10.2% vs. 4.1%).
Edoxaban dosing was adherent to label in 90% of patients, with higher than recommended (60 mg) doses and lower than recommended doses (30 mg) used in 6.6% and 3.3% of the patients, respectively. Heparin lead-in was used in 84.7% of patients. It was more frequently used in PE than DVT patients (91.3% vs. 80.1%; p< 0.0001).
Conclusions: The data describe a clinical practice population of VTE patients that is partially different from prior randomised controlled trials. Edoxaban is largely used adequately in these patients, respecting the recommendations for treatment initiation, dosing, and dose adjustments in special patient populations.
| HOKUSAI-VTE [N = 1,512] | ETNA-VTE [N = 2,680] | ETNA-VTE DVT only [N = 1,559] | ETNA-VTE PE ± DVT [N = 1,121] | p-value DVT vs. PE | |
| Age, years /Female patients | 57 / 39.8 | 65 / 46.5 | 64 / 45.3 | 66 / 48.2 | 0.0052 / 0.1577 |
| Body weight, kg | 84.0 (73.9-95.3) | 80 (70-92) | 80 (70-90) | 81 (70-94) | 0.0031 |
| Acute DVT only | 854 (56.5) | 1,559 (58.2) | 1,559 (100.0) | 0 (0.0) | n.a. |
| PE with or without DVT | 658 (43.5) | 1,121 (41.8) | 0 (0.0) | 1,121 (100.0) | n.a. n.a. |
| Chronic Venous Insufficiency | 24 (1.6) | 297 (11.1) | 214 (13.7) | 83 (7.4) | <0.0001 |
| Cancer | 136 (9.0) | 253 (9.4) | 133 (8.5) | 120 (10.7) | 0.0566 |
| Stroke | 18 (1.2) | 79 (2.9) | 29 (1.9) | 50 (4.5) | 0.0001 |
| CrCL*,**, ml/min | 104.3 (79.0-128.9) | 90.1 (65.7-117.7) | 91.2 (65.5-120.4) | 89.3 (65.9-115.0) | 0.2238 |
| Edoxaban 60 mg | 1,371 (90.7) | 2,351 (87.7) | 1,349 (86.5) | 1,002 (89.4) | 0.0317 |
[Patient characteristics of those in clinical practice (ETNA-VTE) overall and by VTE presentation and those in clinical trials (HOKUSAI-VTE)]
[Dosing according to edoxaban label based on bodyweight, creatinine clearance and P-gp inhibitor use]
To cite this abstract in AMA style:
Cohen AT, Hoffmann U, Hainaut P, Gaine S, Ay C, Coppens M, Schindewolf M, Jimenez D, Brüggenjürgen B, Levy P, Bramlage P, Agnelli G. ETNA VTE Europe: A Contemporary Snapshot of VTE Patients Treated with Edoxaban in Clinical Practice across Eight European Countries [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/etna-vte-europe-a-contemporary-snapshot-of-vte-patients-treated-with-edoxaban-in-clinical-practice-across-eight-european-countries/. Accessed November 30, 2023.« Back to ISTH 2020 Congress
ISTH Congress Abstracts - https://abstracts.isth.org/abstract/etna-vte-europe-a-contemporary-snapshot-of-vte-patients-treated-with-edoxaban-in-clinical-practice-across-eight-european-countries/