Abstract Number: PB/LB02
Meeting: ISTH 2020 Congress
Theme: Venous Thromboembolism and Cardioembolism » VTE Treatment
Background: The direct oral anticoagulant edoxaban was noninferior to conventional therapy with significantly less bleeding in patients with venous thromboembolism (VTE), including severe pulmonary embolism (PE). There is a paucity of contemporary baseline and outcome data comparing patients with and without VTE recurrence in the real-world clinical setting.
Aims: To analyze the impact of each individual provoked and unprovoked risk factor, including cancer, on VTE recurrence.
Methods: From eight European and three Asian countries, unselected acute symptomatic VTE patients treated with edoxaban participated in the non-interventional ETNA-VTE study and were followed for up to 12 months for safety and effectiveness.
Results: Of 4595 patients (48% male, mean age 64.9 years [SD 15.5]), 2666 (58%) were from Europe, 1652 (36%) from Japan, and 277 (6%) from South Korea and Taiwan. The vast majority of patients were on the recommended edoxaban doses of 60mg/30mg QD (4102/4595; 89%). VTE recurrence rates in Europe (68/2666; 2.6%), Japan (38/1652; 2.3%), and South Korea/Taiwan (10/277; 3.6%) were similar. The recurrence rate by index event, i.e., PE with/without DVT and DVT only were both 2.5%. Patients with VTE recurrence vs those without VTE recurrence were younger (62.7 [14.7] vs 65 [15.5] years), had the same VTE-BLEED score (median 1.5), had higher annualized event rates for all-cause mortality (11%/yr vs 5%/yr), major bleeding (5.6%/yr vs 2.4%/yr), and clinically relevant non-major bleeding (6.6%/yr vs 3.5%/yr).
Conclusions: The 12-month recurrence rate of VTE was low in patients receiving edoxaban, overall and by risk subgroups. In patients with active cancer and reversible provoked risk factors, VTE recurrence was more prevalent. Patients with VTE recurrence had higher annualized rates of bleeding events.
| Baseline Characteristics | All patients [N=4595] |
Without VTE recurrence [N=4479] |
With VTE recurrence [N=116] |
| Body weight [kg], mean (SD) | 72.8 (19.20) | 72.8 (19.16) | 75.5 (20.59) |
| Recalculated CrCl [mL/min], mean (SD) | 87.9 (40.61) | 87.7 (40.57) | 96.9 (41.41) |
| Current smoker | 551 (12%) | 535 (12%) | 16 (14%) |
| Active cancer | 539 (12%) | 519 (12%) | 20 (17%) |
| Any reversible provoking risk factor* | 992 (22%) | 960 (21%) | 32 (28%) |
| Thrombophilia** | 92 (2.0%) | 90 (2.0%) | 2 (1.7%) |
| Unprovoked VTE | 2981 (65%) | 2919 (65%) | 62 (53%) |
| History of VTE History of major bleeding |
793 (17%) 96 (2.1%) |
775 (17%) 94 (2.1%) |
18 (16%) 2 (1.7%) |
| All values are n (%) unless otherwise noted. *Includes: major surgery or trauma, prolonged bed rest (5-7 days), and puerperium **Includes: Antiphospholipid syndrome, deficiencies of protein C, protein S, and antithrombotic protein All individual factors will be presented at the conference. |
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[Table 1. Baseline characteristics]
[Figure. VTE recurrence (%) by risk factor]
To cite this abstract in AMA style:
Cohen A, Chen C, Chiu K-, Choi W-, Nakamura M, Zierhut W, Reimitz P-, Unverdorben M, Agnelli G. Low 1-Year Venous Thromboembolic Recurrence Rates in Patients with and without Thrombotic Risk Factors in Routine Clinical Practice Treated with Edoxaban: The Global ETNA-VTE Study [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/low-1-year-venous-thromboembolic-recurrence-rates-in-patients-with-and-without-thrombotic-risk-factors-in-routine-clinical-practice-treated-with-edoxaban-the-global-etna-vte-study/. Accessed November 27, 2021.« Back to ISTH 2020 Congress
ISTH Congress Abstracts - https://abstracts.isth.org/abstract/low-1-year-venous-thromboembolic-recurrence-rates-in-patients-with-and-without-thrombotic-risk-factors-in-routine-clinical-practice-treated-with-edoxaban-the-global-etna-vte-study/