Fragility and long-term clinical outcomes in patients with venous thromboembolism receiving direct oral anticoagulants: From the COMMAND VTE REGISTRY-2

• DOI: 10.1016/j.thromres.2024.02.023
• Publication Date: 2024-02-29T09:27:35Z
• Authors: Yoshito Ogihara; Yugo Yamashita; Takeshi Morimoto; Ryuki Chatani; Kazuhisa Kaneda; Yuji Nishimoto; Nobutaka Ikeda; Yohei Kobayashi; Satoshi Ikeda; Kitae Kim; Moriaki Inoko; Toru Takase; Shuhei Tsuji; Maki Oi; Takuma Takada; Kazunori Otsui; Jiro Sakamoto; Takeshi Inoue; Shunsuke Usami; Po-Min Chen; Kiyonori Togi; Norimichi Koitabashi; Seiichi Hiramori; Kosuke Doi; Hiroshi Mabuchi; Yoshiaki Tsuyuki; Koichiro Murata; Kensuke Takabayashi; Hisato Nakai; Daisuke Sueta; Wataru Shioyama; Tomohiro Dohke; Toru Sato; Ryusuke Nishikawa; Takeshi Kimura; Kaoru Dohi

There is limited data on the safety of direct oral anticoagulants (DOACs) in fragile patients with venous thromboembolism (VTE).We used the COMMAND VTE Registry-2 enrolling patients with acute symptomatic VTE. The study population consisted of 3928 patients receiving DOACs, who were divided into fragile (2136 patients) and non-fragile groups (1792 patients). Fragility was defined as patients of age ≥ 75 years, creatinine clearance level ≤ 50 ml/min, and/or body weight ≤ 50 kg.The fragile group significantly more often received reduced doses of DOACs compared to the non-fragile group (51 % and 19 %, P < 0.001). The cumulative 5-year incidence of major bleeding was numerically higher in the fragile group than the non-fragile group (15.0 % and 11.1 %, P = 0.052), even with no significant excess risk after adjusting for confounders (HR 1.03, 95%CI 0.81-1.31, P = 0.78). The cumulative 5-year incidence of clinically relevant bleeding was significantly higher in the fragile group than the non-fragile group (28.6 % and 19.6 %, P < 0.001), even after adjusting for confounders (HR 1.28, 95%CI 1.08-1.53, P = 0.005). There was no significant difference in cumulative 5-year incidence of recurrent VTE between the groups (9.6 % and 8.9 %, P = 0.68), which was consistent after adjusting for confounders (HR 1.13, 95%CI 0.84-1.51, P = 0.41).Among VTE patients receiving DOACs, fragile patients were associated with a numerically higher rate of major bleeding and a significantly increased risk of clinically relevant bleeding, but not an increased risk of recurrent VTE.