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Association Between Index VTE Event and 12-Months Outcomes for Patients in Routine Clinical Practice Enrolled in the ETNA-VTE-Europe Registry

1Amsterdam University Medical Centers - University of Amsterdam, Department of Vascular Medicine, Amsterdam, the Netherlands, 2Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom, 3Medical University of Vienna, Hematology and Hemostaseology, Vienna, Austria, 4Cliniques Universitaires Saint Luc, UCL, Brussels, Belgium, 5Ludwig-Maximilians-University Munich, Munich, Germany, 6Mater Misericordiae University Hospital, Dublin, Ireland, 7Ramón y Cajal Hospital, Madrid, Spain, 8University of Bern, Bern University Hospital, Swiss Cardiovascular Centre, Division of Angiology, Bern, Switzerland, 9Steinbeis-University, Institute for Health Economics, Berlin, Germany, 10LEGOS, Université Paris - Dauphine, Paris, France, 11University of Castilla-La Mancha, Toledo, Spain, 12Université Paris Descartes, Department of Medicine, Paris, France, 13Institute for Pharmacology and Preventive Medicine, Berlin, Germany, 14University of Perugia, Internal and Cardiovascular Medicine-Stroke Unit, Perugia, Italy

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)
234 (9.7)
89 (38.2)
476 (47.4)
75 (7.5)

86 (8.6)
110 (11.0)
38 (34.9)
565 (40.3)
189 (13.5)

76 (5.4)
124 (8.8)
51 (41.1)
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)
307 (12.8)

891 (88.7)
113 (11.3)

1209 (86.2)
194 (13.8)
*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)
6 (0.25)

47 (1.95)

 29 (2.89)
17 (1.69)

13 (1.29)
4 (0.40)

16 (1.59)

 39 (2.78)
10 (0.71)

8 (0.57)
2 (0.14)

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.

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