Kitae Kim1, Yugo Yamashita2, Takeshi Morimoto3, Takeshi Kitai1, Takafumi Yamane1, Natsuhiko Ehara1, Makoto Kinoshita1, Shuichiro Kaji1, Hidewo Amano4, Toru Takase5, Seiichi Hiramori6, Maki Oi7, Masaharu Akao8, Yohei Kobayashi9, Mamoru Toyofuku10, Toshiaki Izumi11, Tomohisa Tada12, Po-Min Chen13, Koichiro Murata14, Yoshiaki Tsuyuki15, Syunsuke Saga16, Tomoki Sasa17, Jiro Sakamoto18, Minako Kinoshita19, Kiyonori Togi20, Hiroshi Mabuchi21, Kensuke Takabayashi22, Hiroki Shiomi2, Takao Kato2, Takeru Makiyama2, Koh Ono2, Yutaka Furukawa1, Takeshi Kimura2. 1. Department of Cardiovascular Medicine, Kobe City Medical Center General Hospital, Kobe, Japan. 2. Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan. 3. Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan. 4. Department of Cardiovascular Medicine, Kurashiki Central Hospital, Kurashiki, Japan. 5. Department of Cardiology, Kinki University Hospital, Osaka, Japan. 6. Department of Cardiology, Kokura Memorial Hospital, Kitakyushu, Japan. 7. Department of Cardiology, Japanese Red Cross Otsu Hospital, Otsu, Japan. 8. Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan. 9. Department of Cardiovascular Center, Osaka Red Cross Hospital, Osaka, Japan. 10. Department of Cardiology, Japanese Red Cross Wakayama Medical Center, Wakayama, Japan. 11. Cardiovascular Center, The Tazuke Kofukai Medical Research Institute, Kitano Hospital, Osaka, Japan. 12. Department of Cardiology, Shizuoka General Hospital, Shizuoka, Japan. 13. Department of Cardiology, Osaka Saiseikai Noe Hospital, Osaka, Japan. 14. Department of Cardiology, Shizuoka City Shizuoka Hospital, Shizuoka, Japan. 15. Division of Cardiology, Shimada Municipal Hospital, Shimada, Japan. 16. Department of Cardiology, Hyogo Prefectural Amagasaki General Medical Center, Amagasaki, Japan. 17. Department of Cardiology, Kishiwada City Hospital, Kishiwada, Japan. 18. Department of Cardiology, Tenri Hospital, Tenri, Japan. 19. Department of Cardiology, Nishikobe Medical Center, Kobe, Japan. 20. Division of Cardiology, Nara Hospital, Faculty of Medicine, Kinki University, Ikoma, Japan. 21. Department of Cardiology, Koto Memorial Hospital, Higashiomi, Japan. 22. Department of Cardiology, Hirakata Kohsai Hospital, Hirakata, Japan.
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. Georg Thieme Verlag KG Stuttgart · New York.
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 VTEpatients. 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 VTEpatients. Active cancer, previous major bleeding, anemia, thrombocytopenia, and old age were the independent risk factors for major bleeding. Georg Thieme Verlag KG Stuttgart · New York.