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.We investigated the relationship between low BW and long-term outcomes among VTE patients in the DOAC era.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.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).Low BW correlated with higher risks of major bleeding and all-cause death, but not recurrent VTE in the DOAC era.
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