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Active Cancer and Venous Thromboembolism: Safety and Effectiveness of Edoxaban in Patients from the Noninterventional Global ETNA-VTE Program

1Guy's and St Thomas' NHS Foundation Trust, King's College London, London, United Kingdom, 2Nakamura Medical Clinic, Department of Internal Medicine, Pediatrics and Cardiology, Kuwana, Japan, 3Far Eastern Memorial Hospital, Cardiovascular Center, New Taipei City, Taiwan, Province of China, 4Yuan Ze University, Electrical Engineering, Taoyuan City, Taiwan, Province of China, 5Hanyang University Myongji Hospital, Department of Internal Medicine, Goyang-si, Korea, Republic of, 6Daiichi Sankyo Europe GmbH, Clinical Operations and Biostatistics and Data Operations, Munich, Germany, 7Daiichi Sankyo, Inc., Basking Ridge, United States, 8University of Perugia, Internal and Cardiovascular Medicine-Stroke Unit, Perugia, Italy

Abstract Number: LPB0090

Meeting: ISTH 2021 Congress

Theme: Venous Thromboembolism » Cancer Associated Thrombosis

Background: Active cancer is a major risk factor for recurrent venous thromboembolism (VTE) and major bleeding (MB). The direct oral anticoagulant edoxaban was noninferior to dalteparin for the composite endpoint of recurrent VTE or MB in the randomized Hokusai VTE Cancer trial. Data from real-world practice setting complement clinical trial results and can be of particular clinical relevance.

Aims: To investigate the safety and effectiveness of edoxaban in patients with active cancer and VTE in real world clinical practice

Methods: The prospective, noninterventional global ETNA-VTE program enrolled from European and Asian countries unselected patients with acute, symptomatic VTE who were treated with edoxaban. Written informed consent and ethics committee approvals were obtained. Baseline and clinical event data were collected over a period of up to 12-months. Patients with active cancer were identified according to medical history and included in this analysis.

Results: Of 4,595 patients enrolled, 539 (11.7%) had active cancer, most of whom (77%) were from Japan. Baseline characteristics of patients with and without active cancer were similar, with a few exceptions: patients with active cancer had lower body weight, lower percentage of VTE history, higher percentage of bleeding history, and higher VTE-BLEED score (Table 1). The vast majority (89%) of patients with active cancer received the recommended edoxaban dose according to prescribing information. At 1-year follow up, the annualized clinical event rate was 6.3% for recurrent VTE, 8.2% for ISTH MB (intracranial hemorrhage 0.6%, major gastrointestinal bleeding 2.5%). Malignancy-related deaths accounted for the majority of all-cause mortality (Table 2).

All Patients
 (N = 4,595)		 Patients with active cancer
 (n = 539)		 Patients with no active cancer
 (n = 4,056)
Age – yr, Mean (SD) 64.9 (15.5) 66.9 (11.9) 64.6 (15.9)
Male gender, n (%) 2,222 (48.4) 233 (43.2) 1,989 (49.0)
Weight – kg, Mean (SD) 72.8 (19.2) 61.8 (15.1) 74.3 (19.2)
Creatinine Clearance – mL/min, Mean (SD) 87.9 (40.6) 82.0 (36.2) 88.8 (41.1)
VTE-BLEED score, mean (SD) 1.8 (1.5) 3.9 (1.3) 1.6 (1.3)
HAS-BLED score*, mean (SD) 1.7 (1.2) 1.6 (1.2) 1.7 (1.2)
History of VTE 793 (17.3) 40 (7.4) 753 (18.6)
History of bleeding 207 (4.5) 47 (8.7) 160 (3.9)
History of major bleeding 96 (2.1) 18 (3.3) 78 (1.9)

Baseline characteristics and medical history*Modified HAS-BLED score excluding labile INR

Data shown as
 %/year, [95%CI]		 All Patients
 (N = 4,595)		 Patients with active cancer
 (n = 539)		 Patients with no active cancer
 (n = 4,056)
Recurrent VTE 3.09 [2.55; 3.70] 6.33 [3.87; 9.77] 2.79 [2.26; 3.41]
      PE with or without DVT 1.19 [0.87; 1.59] 2.81 [1.29; 5.34] 1.04 [0.73; 1.44]
      DVT only 1.99 [1.56; 2.49] 4.39 [2.40; 7.36] 1.76 [1.35; 2.27]
Major bleeding (ISTH) 2.44 [1.97; 2.99] 8.23 [5.37; 12.06] 1.91 [1.48; 2.43]
Intracranial hemorrhage 0.58 [0.36; 0.88] 0.62 [0.08; 2.24] 0.58 [0.35; 0.89]
Major GI bleeding 0.66 [0.43; 0.97] 2.48 [1.07; 4.90] 0.49 [0.28; 0.78]
All-cause death 5.15 [4.45; 5.92] 31.89 [26.03; 38.67] 2.67 [2.15; 3.27]
Malignancy death 2.60 [2.11; 3.17] 25.08 [19.92; 31.17] 0.52 [0.31; 0.82]
Cardiovascular death 1.08 [0.77; 1.46] 2.79 [1.27; 5.29]  0.92 [0.63; 1.30]

Annualized rates of clinical events

Conclusions: In the real-world global ETNA-VTE program, patients with active cancer had higher VTE and bleeding event rates than those without. Edoxaban demonstrated a safety and effectiveness profile in patients with VTE and active cancer that is consistent with the findings from previous randomized controlled trial.

To cite this abstract in AMA style:

Cohen A, Nakamura M, Chiu K-, Choi W-, Reimitz P-, Jiang W, Chen C, Unverdorben M, Agnelli G. Active Cancer and Venous Thromboembolism: Safety and Effectiveness of Edoxaban in Patients from the Noninterventional Global ETNA-VTE Program [abstract]. Res Pract Thromb Haemost. 2021; 5 (Suppl 2). https://abstracts.isth.org/abstract/active-cancer-and-venous-thromboembolism-safety-and-effectiveness-of-edoxaban-in-patients-from-the-noninterventional-global-etna-vte-program/. Accessed October 1, 2023.

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