Low Body Weight and Long-term Outcomes in Patients with Venous Thromboembolism: Insights from the COMMAND VTE Registry-2

Abstract

Background

Major bleeding and recurrent venous thromboembolism (VTE) both lead to a poor prognosis among patients with VTE. Low body weight (BW) may be a risk factor for bleeding; however, data on its impact remain limited in the direct oral anticoagulant (DOAC) era.

Purpose

We investigated the relationship between low BW and long-term outcomes among VTE patients in the DOAC era.

Methods

From the COMMAND VTE Registry-2 in Japan between January 2015 and August 2020, we analyzed 4,959 patients with symptomatic VTE, who were divided into low BW (≤60 kg) (N = 2,897) and non-low BW (>60 kg) (N = 2,062) groups. The primary outcome was major bleeding.

Results

The low BW group was older (71.3 vs. 62.5 years, P < 0.001), included a higher percentage of female (75% vs. 36%, P < 0.001), and received initial intensive DOAC therapy less often (64% vs. 75%, P < 0.001) and reduced maintenance DOAC doses more frequently (51% vs. 15%, P < 0.001) than the non-low BW group. The risks of major bleeding (16.7% vs. 10.8% at 5 years; adjusted HR 1.43, 95%CI 1.15–1.77, P = 0.001) and all-cause death (38.9% vs. 23.2%; HR 1.59, 95%CI 1.39–1.81, P < 0.001) were higher in the low BW group than in the non-low BW group, while the risk of recurrent VTE was similar (9.4% vs. 9.7%; HR 0.98, 95%CI 0.75–1.29, P = 0.90).

Conclusion

Low BW correlated with higher risks of major bleeding and all-cause death, but not recurrent VTE in the DOAC era.

Keywords

venous thromboembolism - hemorrhage - recurrence - mortality - body weight - anticoagulants - factor Xa inhibitors

Contributors' Statement

S.K. served as principal author, had full access to all the data in the study, and takes responsibility for the integrity of the data and the accuracy of the data analysis; S.K., Y.O., Y.Y., T.M., T.K., and K.Dohi contributed to the design of the study, the analysis and interpretation of data, and drafted the manuscript; R.C., K.Ka., Y.N., N.I., Y.K., S.I., K.Ki., M.I., T.Takase, S.T., M.O., T.Takada, K.O., J.S., T.I., S.U., P.C., K.To., N.K., S.H., K.Doi, H.M., Y.T., K.M., K.Ta., H.N., D.S., W.S., T.D., T.S., and R.N. contributed to acquisition and interpretation of data and reviewed the manuscript. All authors approved the final version of the report.

Publication History

Received: 26 August 2025

Accepted after revision: 01 December 2025

Accepted Manuscript online:
03 December 2025

Article published online:
15 December 2025

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