Fragility and long-term clinical outcomes in patients with venous thromboembolism receiving direct oral anticoagulants : From the COMMAND VTE REGISTRY-2
Copyright © 2024 Elsevier Ltd. All rights reserved..
INTRODUCTION: There is limited data on the safety of direct oral anticoagulants (DOACs) in fragile patients with venous thromboembolism (VTE).
MATERIALS AND METHODS: 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.
RESULTS: 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).
CONCLUSIONS: 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.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2024 |
|---|---|
| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:236 |
|---|---|
| Enthalten in: |
Thrombosis research - 236(2024) vom: 15. Apr., Seite 191-200 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Ogihara, Yoshito [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Anticoagulants |
|---|
| Anmerkungen: |
Date Completed 01.04.2024 Date Revised 01.04.2024 published: Print-Electronic Citation Status MEDLINE |
|---|
| doi: |
10.1016/j.thromres.2024.02.023 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM369513428 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM369513428 | ||
| 003 | DE-627 | ||
| 005 | 20240401232747.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 240311s2024 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1016/j.thromres.2024.02.023 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1359.xml |
| 035 | |a (DE-627)NLM369513428 | ||
| 035 | |a (NLM)38461613 | ||
| 035 | |a (PII)S0049-3848(24)00064-1 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Ogihara, Yoshito |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Fragility and long-term clinical outcomes in patients with venous thromboembolism receiving direct oral anticoagulants |b From the COMMAND VTE REGISTRY-2 |
| 264 | 1 | |c 2024 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 01.04.2024 | ||
| 500 | |a Date Revised 01.04.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2024 Elsevier Ltd. All rights reserved. | ||
| 520 | |a INTRODUCTION: There is limited data on the safety of direct oral anticoagulants (DOACs) in fragile patients with venous thromboembolism (VTE) | ||
| 520 | |a MATERIALS AND METHODS: 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 | ||
| 520 | |a RESULTS: 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) | ||
| 520 | |a CONCLUSIONS: 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 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Direct oral anticoagulant | |
| 650 | 4 | |a Fragile patients | |
| 650 | 4 | |a Hemorrhage | |
| 650 | 4 | |a Recurrence | |
| 650 | 4 | |a Venous thromboembolism | |
| 650 | 7 | |a Anticoagulants |2 NLM | |
| 700 | 1 | |a Yamashita, Yugo |e verfasserin |4 aut | |
| 700 | 1 | |a Morimoto, Takeshi |e verfasserin |4 aut | |
| 700 | 1 | |a Chatani, Ryuki |e verfasserin |4 aut | |
| 700 | 1 | |a Kaneda, Kazuhisa |e verfasserin |4 aut | |
| 700 | 1 | |a Nishimoto, Yuji |e verfasserin |4 aut | |
| 700 | 1 | |a Ikeda, Nobutaka |e verfasserin |4 aut | |
| 700 | 1 | |a Kobayashi, Yohei |e verfasserin |4 aut | |
| 700 | 1 | |a Ikeda, Satoshi |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Kitae |e verfasserin |4 aut | |
| 700 | 1 | |a Inoko, Moriaki |e verfasserin |4 aut | |
| 700 | 1 | |a Takase, Toru |e verfasserin |4 aut | |
| 700 | 1 | |a Tsuji, Shuhei |e verfasserin |4 aut | |
| 700 | 1 | |a Oi, Maki |e verfasserin |4 aut | |
| 700 | 1 | |a Takada, Takuma |e verfasserin |4 aut | |
| 700 | 1 | |a Otsui, Kazunori |e verfasserin |4 aut | |
| 700 | 1 | |a Sakamoto, Jiro |e verfasserin |4 aut | |
| 700 | 1 | |a Inoue, Takeshi |e verfasserin |4 aut | |
| 700 | 1 | |a Usami, Shunsuke |e verfasserin |4 aut | |
| 700 | 1 | |a Chen, Po-Min |e verfasserin |4 aut | |
| 700 | 1 | |a Togi, Kiyonori |e verfasserin |4 aut | |
| 700 | 1 | |a Koitabashi, Norimichi |e verfasserin |4 aut | |
| 700 | 1 | |a Hiramori, Seiichi |e verfasserin |4 aut | |
| 700 | 1 | |a Doi, Kosuke |e verfasserin |4 aut | |
| 700 | 1 | |a Mabuchi, Hiroshi |e verfasserin |4 aut | |
| 700 | 1 | |a Tsuyuki, Yoshiaki |e verfasserin |4 aut | |
| 700 | 1 | |a Murata, Koichiro |e verfasserin |4 aut | |
| 700 | 1 | |a Takabayashi, Kensuke |e verfasserin |4 aut | |
| 700 | 1 | |a Nakai, Hisato |e verfasserin |4 aut | |
| 700 | 1 | |a Sueta, Daisuke |e verfasserin |4 aut | |
| 700 | 1 | |a Shioyama, Wataru |e verfasserin |4 aut | |
| 700 | 1 | |a Dohke, Tomohiro |e verfasserin |4 aut | |
| 700 | 1 | |a Sato, Toru |e verfasserin |4 aut | |
| 700 | 1 | |a Nishikawa, Ryusuke |e verfasserin |4 aut | |
| 700 | 1 | |a Kimura, Takeshi |e verfasserin |4 aut | |
| 700 | 1 | |a Dohi, Kaoru |e verfasserin |4 aut | |
| 700 | 0 | |a COMMAND VTE Registry-2 Investigators |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Thrombosis research |d 1974 |g 236(2024) vom: 15. Apr., Seite 191-200 |w (DE-627)NLM000010839 |x 1879-2472 |7 nnns |
| 773 | 1 | 8 | |g volume:236 |g year:2024 |g day:15 |g month:04 |g pages:191-200 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1016/j.thromres.2024.02.023 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 236 |j 2024 |b 15 |c 04 |h 191-200 | ||