Abstract Number: PB2432
Meeting: ISTH 2020 Congress
Theme: Venous Thromboembolism and Cardioembolism » VTE Treatment
Background: Obesity (defined as a body mass index [BMI] ≥30 kg/m2) increases the risk for first spontaneous venous thromboembolism (VTE) two-fold. During the treatment of VTE, obesity may also affect bioavailability, distribution, and half-life of edoxaban, and consequently, patient outcomes. Dose reduction of edoxaban is recommended in patients with a bodyweight ≤60 kg.
Aims: To characterize obese patients and to investigate outcomes in patients treated with edoxaban categorised by BMI.
Methods: Patients in ETNA-VTE-Europe who had acute symptomatic VTE and received edoxaban were recruited across eight European countries. Patients were divided according to BMI [kg/m2]: 18.5-25, 25-30 and ≥30.
Results: Of 2131 patients, 573 were normal weight, 849 overweight (BMI 25-30) and 560 obese (BMI ≥30); 149 patients had no BMI data and 18 patients had a BMI < 18.5. Obese patients were more often female, had higher rates of hypertension and diabetes, chronic venous insufficiency and a higher eGFR than non-obese patients. They also had higher rates of prior VTE and were receiving the 60 mg edoxaban dose more often (Table 1). At 1-year follow up, VTE recurrence was 2.67% and consistent across categories. Any bleeding was observed in 12.29% and major bleeding in 1.69% with no increase with BMI. While all-cause mortality was in the same order across BMI groups, there was a trend for a reduced cardiovascular mortality in obese patients (Table 2). Table 1: Baseli... Table 2: Clinic...
Conclusions: Obesity does not appear to substantially affect the risks of recurrent VTE and any bleeding complications in a contemporary cohort of edoxaban treated patients. Apart from all-cause mortality following a U-shape association and CV-mortality being lowest in BMI ≥30, there were no appreciable differences in outcomes across the various subgroups.
| Overall* [N=2131] | BMI 18.5-25* [N=573] | BMI 25-30* [N=849] | BMI ≥30 * [N=560] | |
| Female, n (%) | 983 (46.1%) | 297 (51.8%) | 335 (39.5%) | 322 (51.3%) |
| Age, years, mean ± SD | 62.4 ± 16.07 | 61.9 ± 18.19 | 64.0 ± 14.93 | 61.9 ± 14.97 |
| BMI, kg/m2, mean ± SD | 27.9 ± 5.00 | 22.7 ± 1.85 | 27.3 ± 1.37 | 34.2 ± 4.04 |
| recalc. eGFR (Cockroft-Gault), ml/min, mean ± SD | 95.7 ± 38.95 | 82.1 ± 31.85 | 92.3 ± 34.60 | 114.0 ± 44.88 |
| Frailty (physician judgement), n (%) | 261 (12.2%) | 75 (13.1%) | 106 (12.5%) | 75 (11.9%) |
| Medical history, n (%) Hypertension Diabetes Mellitus Chronic venous insufficiency |
888 (41.7%) 235 (11.0%) 234 (11.0%) |
165 (28.8%) 40 (7.0%) 49 (8.6%) |
359 (42.3%) 81 (9.5%) 104 (12.2%) |
360 (57.3%) 117 (18.6%) 85 (13.5%) |
| History of VTE, n (%) Prior PE±DVT Prior DVT |
160 (7.5%) |
38 (6.6%) |
55 (6.5%) |
54 (8.6%) |
| Edoxaban treatment at baseline, n (%) Edoxaban 60 mg Edoxaban 30 mg |
1873 (87.9%) |
449 (78.4%) |
771 (90.8%) |
521 (93.0%) |
| DVT, deep vein thrombosis; eGFR, estimated glomerular filtration rate; PE, pulmonary embolism; SD, standard deviation; VTE, venous thromboembolism. * Patients with history of cancer, active cancer at baseline or new cancer within six months (182 days) after start of acute index VTE were excluded from analysis. One-hundred forty nine patients had missing BMI. | ||||
[Table 1: Baseline characteristics of patients enrolled in the ETNA-VTE-Europe study according to BMI [N=2131]*]
| Outcomes during 12-months follow-up*, n (%) | Overallǂ [N=2131] | BMI 18.5-25 [N=573] | BMI < 25 [N=573] | BMI ≥30 [N=560] |
| VTE recurrences PE with or w/o DVT DVT only |
57 (2.67%) 24 (1.13%) 38 (1.78%) |
14 (2.44%) 4 (0.70%) 10 (1.75%) |
24 (2.83%) 11 (1.30%) 17 (2.00%) |
17 (2.71%) 7 (1.11%) 12 (1.91%) |
| Any bleeding ICH Major bleeding [ISTH] CRNM bleeding Major GI bleeding |
262 (12.29%) 8 (0.38%) 36 (1.69%) 69 (3.24%) |
78 (13.61%) 1 (0.17%) 10 (1.75%) 18 (3.14%) |
97 (11.43%) 5 (0.59%) 17 (2.00%) 25 (2.94%) |
87 (13.85%) 1 (0.16%) 7 (1.11%) 28 (4.46%) |
| All−cause mortality CV mortality |
46 (2.16%) 23 (1.08%) |
17 (2.97%) 9 (1.57%) |
15 (1.77%) 9 (1.06%) |
15 (2.39%) 5 (0.80%) |
| Any stroke Ischaemic stroke Haemorrhagic stroke |
13 (0.61%) 7 (0.33%) 3 (0.14%) |
3 (0.52%) 2 (0.35%) 0 (0.00%) |
4 (0.47%) 1 (0.12%) 2 (0.24%) |
5 (0.80%) 4 (0.64%) 0 (0.00%) |
| Stroke or systemic embolism | 16 (0.75%) | 3 (0.52%) | 5 (0.59%) | 8 (1.27%) |
| CRNM, clinically relevant nonmajor; CV, cardiovascular; DVT, deep vein thrombosis; GI, gastrointestinal; ICH, intracranial haemorrhage; ISTH, International Society on Thrombosis and Haemostasis; PE, pulmonary embolism; VTE, venous thromboembolism. *Overall population Patients with history of cancer, active cancer at baseline or new cancer within six months (182 days) after start of acute index VTE were excluded from analysis. ǂOne-hundred forty nine patients had missing BMI. | ||||
[Table 2: Clinical outcomes of patients enrolled in the ETNA-VTE-Europe study during 12-month follow-up according to BMI (N=2131)*]
To cite this abstract in AMA style:
Schindewolf M, Brüggenjürgen B, Ay C, Hainaut P, Hoffmann U, Gaine S, Coppens M, Jiménez D, Levy P, López Bastida J, Vicaut E, Bramlage P, Agnelli G, Cohen AT, ETNA-VTE-Europe Investigators . ETNA-VTE Europe: The Effect of Body Mass Index on 12-Month Outcomes in VTE Patients with Edoxaban [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/etna-vte-europe-the-effect-of-body-mass-index-on-12-month-outcomes-in-vte-patients-with-edoxaban/. Accessed November 30, 2023.« Back to ISTH 2020 Congress
ISTH Congress Abstracts - https://abstracts.isth.org/abstract/etna-vte-europe-the-effect-of-body-mass-index-on-12-month-outcomes-in-vte-patients-with-edoxaban/