Risk Factors for Major Bleeding during Prolonged Anticoagulation Therapy in Patients with Venous Thromboembolism: From the COMMAND VTE Registry

Kitae Kim; Yugo Yamashita; Takeshi Morimoto; Takeshi Kitai; Takafumi Yamane; Natsuhiko Ehara; Makoto Kinoshita; Shuichiro Kaji; Hidewo Amano; Toru Takase; Seiichi Hiramori; Maki Oi; Masaharu Akao; Yohei Kobayashi; Mamoru Toyofuku; Toshiaki Izumi; Tomohisa Tada; Po-Min Chen; Koichiro Murata; Yoshiaki Tsuyuki; Syunsuke Saga; Tomoki Sasa; Jiro Sakamoto; Minako Kinoshita; Kiyonori Togi; Hiroshi Mabuchi; Kensuke Takabayashi; Hiroki Shiomi; Takao Kato; Takeru Makiyama; Koh Ono; Yutaka Furukawa; Takeshi Kimura; On behalf of the COMMAND VTE Registry Investigators

doi:10.1055/s-0039-1692425

Thrombosis and Haemostasis, Inhaltsverzeichnis

Thromb Haemost 2019; 119(09): 1498-1507
DOI: 10.1055/s-0039-1692425

Stroke, Systemic or Venous Thromboembolism

Georg Thieme Verlag KG Stuttgart · New York

Risk Factors for Major Bleeding during Prolonged Anticoagulation Therapy in Patients with Venous Thromboembolism: From the COMMAND VTE Registry

Kitae Kim

¹Department of Cardiovascular Medicine, Kobe City Medical Center General Hospital, Kobe, Japan

,

Yugo Yamashita

²Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan

,

Takeshi Morimoto

³Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan

,

Takeshi Kitai

¹Department of Cardiovascular Medicine, Kobe City Medical Center General Hospital, Kobe, Japan

,

Takafumi Yamane

¹Department of Cardiovascular Medicine, Kobe City Medical Center General Hospital, Kobe, Japan

,

Natsuhiko Ehara

¹Department of Cardiovascular Medicine, Kobe City Medical Center General Hospital, Kobe, Japan

,

Makoto Kinoshita

¹Department of Cardiovascular Medicine, Kobe City Medical Center General Hospital, Kobe, Japan

,

Shuichiro Kaji

¹Department of Cardiovascular Medicine, Kobe City Medical Center General Hospital, Kobe, Japan

,

Hidewo Amano

⁴Department of Cardiovascular Medicine, Kurashiki Central Hospital, Kurashiki, Japan

,

Toru Takase

⁵Department of Cardiology, Kinki University Hospital, Osaka, Japan

,

Seiichi Hiramori

⁶Department of Cardiology, Kokura Memorial Hospital, Kitakyushu, Japan

,

Maki Oi

⁷Department of Cardiology, Japanese Red Cross Otsu Hospital, Otsu, Japan

,

Masaharu Akao

⁸Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan

,

Yohei Kobayashi

⁹Department of Cardiovascular Center, Osaka Red Cross Hospital, Osaka, Japan

,

Mamoru Toyofuku

¹⁰Department of Cardiology, Japanese Red Cross Wakayama Medical Center, Wakayama, Japan

,

Toshiaki Izumi

¹¹Cardiovascular Center, The Tazuke Kofukai Medical Research Institute, Kitano Hospital, Osaka, Japan

,

Tomohisa Tada

¹²Department of Cardiology, Shizuoka General Hospital, Shizuoka, Japan

,

Po-Min Chen

¹³Department of Cardiology, Osaka Saiseikai Noe Hospital, Osaka, Japan

,

Koichiro Murata

¹⁴Department of Cardiology, Shizuoka City Shizuoka Hospital, Shizuoka, Japan

,

Yoshiaki Tsuyuki

¹⁵Division of Cardiology, Shimada Municipal Hospital, Shimada, Japan

,

Syunsuke Saga

¹⁶Department of Cardiology, Hyogo Prefectural Amagasaki General Medical Center, Amagasaki, Japan

,

Tomoki Sasa

¹⁷Department of Cardiology, Kishiwada City Hospital, Kishiwada, Japan

,

Jiro Sakamoto

¹⁸Department of Cardiology, Tenri Hospital, Tenri, Japan

,

Minako Kinoshita

¹⁹Department of Cardiology, Nishikobe Medical Center, Kobe, Japan

,

Kiyonori Togi

²⁰Division of Cardiology, Nara Hospital, Faculty of Medicine, Kinki University, Ikoma, Japan

,

Hiroshi Mabuchi

²¹Department of Cardiology, Koto Memorial Hospital, Higashiomi, Japan

,

Kensuke Takabayashi

²²Department of Cardiology, Hirakata Kohsai Hospital, Hirakata, Japan

,

Hiroki Shiomi

²Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan

,

Takao Kato

²Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan

,

Takeru Makiyama

²Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan

,

Koh Ono

²Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan

,

Yutaka Furukawa

¹Department of Cardiovascular Medicine, Kobe City Medical Center General Hospital, Kobe, Japan

,

Takeshi Kimura

²Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan

,

On behalf of the COMMAND VTE Registry Investigators

› Institutsangaben

Abstract

Background There are limited data assessing the risk for bleeding on anticoagulation therapy beyond the acute phase in patients with venous thromboembolism (VTE). The present study aimed to identify risk factors for major bleeding during prolonged anticoagulation therapy in VTE patients.

Patients and Methods The COMMAND VTE Registry is a multicenter registry enrolling 3,027 consecutive patients with acute symptomatic VTE. The current study population consisted of 2,728 patients who received anticoagulation therapy beyond the acute phase, after excluding those patients with major bleeding events (n = 48), death (n = 66), or loss to follow-up (n = 32) during the initial parenteral anticoagulation period within 10 days after diagnosis, and those without anticoagulation therapy beyond 10 days after diagnosis (n = 153).

Results During the median follow-up period of 555 days, major bleeding occurred in 189 patients (70 patients within 3 months; 119 patients beyond 3 months) with fatal bleeding in 24 patients (13%). The cumulative incidence of major bleeding was 2.7% at 3 months, 5.2% at 1 year, and 11.8% at 5 years. Active cancer (hazard ratio [HR], 3.06, 95% confidence interval [CI], 2.23–4.18), previous major bleeding (HR, 2.38, 95% CI, 1.51–3.59), anemia (HR, 1.75, 95% CI, 1.27–2.43), thrombocytopenia (HR, 2.11, 95% CI, 1.27–3.33), and age ≥75 years (HR, 1.64, 95% CI, 1.22–2.20) were independently associated with an increased risk for major bleeding by the multivariable Cox regression model.

Conclusion Major bleeding events were not uncommon during prolonged anticoagulation therapy in real-world VTE patients. Active cancer, previous major bleeding, anemia, thrombocytopenia, and old age were the independent risk factors for major bleeding.

Keywords

venous thromboembolism - bleeding - anticoagulation therapy - risk factor

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Referenzen

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