Application of the Academic Research Consortium High Bleeding Risk Criteria in an All-Comers Registry of Percutaneous Coronary Intervention
BACKGROUND:Recently, the Academic Research Consortium for High Bleeding Risk (ARC-HBR) has been proposed to standardize the definition of HBR, which was arbitrarily defined as a Bleeding Academic Research Consortium 3 or 5 bleeding ≥4% at 1-year. However, the prevalence and the expected bleeding eve...
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Published in | Circulation. Cardiovascular interventions Vol. 12; no. 11; p. e008307 |
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Main Authors | , , , , , , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
American Heart Association, Inc
01.11.2019
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Online Access | Get full text |
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Abstract | BACKGROUND:Recently, the Academic Research Consortium for High Bleeding Risk (ARC-HBR) has been proposed to standardize the definition of HBR, which was arbitrarily defined as a Bleeding Academic Research Consortium 3 or 5 bleeding ≥4% at 1-year. However, the prevalence and the expected bleeding event rate of HBR patients defined by ARC-HBR criteria are currently unknown in the real-world percutaneous coronary intervention practice.
METHODS:We applied the ARC-HBR criteria in the CREDO-Kyoto (Coronary Revascularization Demonstrating Outcome Study in Kyoto) registry cohort-2, a multicenter registry that enrolled 13 058 consecutive patients who underwent their first percutaneous coronary intervention. The primary bleeding end point was defined as the Global Utilization of Streptokinase and Tissue plasminogen activator for Occluded coronary arteries moderate/severe bleeding. There were 5570 patients (43%) in the HBR group and 7488 patients in the no-HBR group.
RESULTS:Cumulative incidence of the primary bleeding end point was much higher in the HBR group than in the no-HBR group (10.4% versus 3.4% at 1-year, and 18.9% versus 6.6% at 5-year, P<0.0001). Presence of each ARC-HBR major or even minor criterion, in isolation, with the exception of liver cirrhosis and prior ischemic stroke, was also associated with major bleeding risk higher than 4% at 1-year. Cumulative 5-year incidence of the primary bleeding end point got incrementally higher as the number of the ARC-HBR major criteria increased (≥3 majors49.9%, 2 majors30.6%, 1 major18.5%, ≥2 minors14.7%, and no-HBR6.6%, P<0.0001).
CONCLUSIONS:ARC-HBR criteria successfully identified those patients with very HBR after percutaneous coronary intervention, who represented 43% of patients in this all-comers registry. |
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AbstractList | BACKGROUNDRecently, the Academic Research Consortium for High Bleeding Risk (ARC-HBR) has been proposed to standardize the definition of HBR, which was arbitrarily defined as a Bleeding Academic Research Consortium 3 or 5 bleeding ≥4% at 1-year. However, the prevalence and the expected bleeding event rate of HBR patients defined by ARC-HBR criteria are currently unknown in the real-world percutaneous coronary intervention practice. METHODSWe applied the ARC-HBR criteria in the CREDO-Kyoto (Coronary Revascularization Demonstrating Outcome Study in Kyoto) registry cohort-2, a multicenter registry that enrolled 13 058 consecutive patients who underwent their first percutaneous coronary intervention. The primary bleeding end point was defined as the Global Utilization of Streptokinase and Tissue plasminogen activator for Occluded coronary arteries moderate/severe bleeding. There were 5570 patients (43%) in the HBR group and 7488 patients in the no-HBR group. RESULTSCumulative incidence of the primary bleeding end point was much higher in the HBR group than in the no-HBR group (10.4% versus 3.4% at 1-year, and 18.9% versus 6.6% at 5-year, P<0.0001). Presence of each ARC-HBR major or even minor criterion, in isolation, with the exception of liver cirrhosis and prior ischemic stroke, was also associated with major bleeding risk higher than 4% at 1-year. Cumulative 5-year incidence of the primary bleeding end point got incrementally higher as the number of the ARC-HBR major criteria increased (≥3 majors: 49.9%, 2 majors: 30.6%, 1 major: 18.5%, ≥2 minors: 14.7%, and no-HBR: 6.6%, P<0.0001). CONCLUSIONSARC-HBR criteria successfully identified those patients with very HBR after percutaneous coronary intervention, who represented 43% of patients in this all-comers registry. BACKGROUND:Recently, the Academic Research Consortium for High Bleeding Risk (ARC-HBR) has been proposed to standardize the definition of HBR, which was arbitrarily defined as a Bleeding Academic Research Consortium 3 or 5 bleeding ≥4% at 1-year. However, the prevalence and the expected bleeding event rate of HBR patients defined by ARC-HBR criteria are currently unknown in the real-world percutaneous coronary intervention practice. METHODS:We applied the ARC-HBR criteria in the CREDO-Kyoto (Coronary Revascularization Demonstrating Outcome Study in Kyoto) registry cohort-2, a multicenter registry that enrolled 13 058 consecutive patients who underwent their first percutaneous coronary intervention. The primary bleeding end point was defined as the Global Utilization of Streptokinase and Tissue plasminogen activator for Occluded coronary arteries moderate/severe bleeding. There were 5570 patients (43%) in the HBR group and 7488 patients in the no-HBR group. RESULTS:Cumulative incidence of the primary bleeding end point was much higher in the HBR group than in the no-HBR group (10.4% versus 3.4% at 1-year, and 18.9% versus 6.6% at 5-year, P<0.0001). Presence of each ARC-HBR major or even minor criterion, in isolation, with the exception of liver cirrhosis and prior ischemic stroke, was also associated with major bleeding risk higher than 4% at 1-year. Cumulative 5-year incidence of the primary bleeding end point got incrementally higher as the number of the ARC-HBR major criteria increased (≥3 majors49.9%, 2 majors30.6%, 1 major18.5%, ≥2 minors14.7%, and no-HBR6.6%, P<0.0001). CONCLUSIONS:ARC-HBR criteria successfully identified those patients with very HBR after percutaneous coronary intervention, who represented 43% of patients in this all-comers registry. |
Author | Natsuaki, Masahiro Tada, Tomohisa Toyofuku, Mamoru Yamaji, Kyohei Watanabe, Hirotoshi Kadota, Kazushige Nakagawa, Yoshihisa Nagao, Kazuya Furukawa, Yutaka Shiomi, Hiroki Kato, Takao Kimura, Takeshi Morimoto, Takeshi Shizuta, Satoshi Ando, Kenji |
AuthorAffiliation | Department of Cardiovascular Medicine, Saga University, Japan (M.N.). Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan (T.M.). Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Japan (H.S., H.W., S.S., T. Kato, T. Kimura). Division of Cardiology, Kokura Memorial Hospital, Kitakyushu, Japan (K.Y., K.A.). Department of Cardiovascular Medicine, Shiga University of Medical Science Hospital, Otsu, Japan (Y.N.). Department of Cardiovascular Medicine, Kobe City Medical Center General Hospital, Japan (Y.F.). Division of Cardiology, Shizuoka General Hospital, Japan (T.T.). Department of Cardiovascular Center, Osaka Red Cross Hospital, Japan (K.N.). Division of Cardiology, Kurashiki Central Hospital, Japan (K.K.). Division of Cardiology, Wakayama Red Cross Hospital, Wakayama, Japan (M.T.) |
AuthorAffiliation_xml | – name: Department of Cardiovascular Medicine, Saga University, Japan (M.N.). Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan (T.M.). Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Japan (H.S., H.W., S.S., T. Kato, T. Kimura). Division of Cardiology, Kokura Memorial Hospital, Kitakyushu, Japan (K.Y., K.A.). Department of Cardiovascular Medicine, Shiga University of Medical Science Hospital, Otsu, Japan (Y.N.). Department of Cardiovascular Medicine, Kobe City Medical Center General Hospital, Japan (Y.F.). Division of Cardiology, Shizuoka General Hospital, Japan (T.T.). Department of Cardiovascular Center, Osaka Red Cross Hospital, Japan (K.N.). Division of Cardiology, Kurashiki Central Hospital, Japan (K.K.). Division of Cardiology, Wakayama Red Cross Hospital, Wakayama, Japan (M.T.) |
Author_xml | – sequence: 1 givenname: Masahiro surname: Natsuaki fullname: Natsuaki, Masahiro organization: Department of Cardiovascular Medicine, Saga University, Japan (M.N.). Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan (T.M.). Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Japan (H.S., H.W., S.S., T. Kato, T. Kimura). Division of Cardiology, Kokura Memorial Hospital, Kitakyushu, Japan (K.Y., K.A.). Department of Cardiovascular Medicine, Shiga University of Medical Science Hospital, Otsu, Japan (Y.N.). Department of Cardiovascular Medicine, Kobe City Medical Center General Hospital, Japan (Y.F.). Division of Cardiology, Shizuoka General Hospital, Japan (T.T.). Department of Cardiovascular Center, Osaka Red Cross Hospital, Japan (K.N.). Division of Cardiology, Kurashiki Central Hospital, Japan (K.K.). Division of Cardiology, Wakayama Red Cross Hospital, Wakayama, Japan (M.T.) – sequence: 2 givenname: Takeshi surname: Morimoto fullname: Morimoto, Takeshi – sequence: 3 givenname: Hiroki surname: Shiomi fullname: Shiomi, Hiroki – sequence: 4 givenname: Kyohei surname: Yamaji fullname: Yamaji, Kyohei – sequence: 5 givenname: Hirotoshi surname: Watanabe fullname: Watanabe, Hirotoshi – sequence: 6 givenname: Satoshi surname: Shizuta fullname: Shizuta, Satoshi – sequence: 7 givenname: Takao surname: Kato fullname: Kato, Takao – sequence: 8 givenname: Kenji surname: Ando fullname: Ando, Kenji – sequence: 9 givenname: Yoshihisa surname: Nakagawa fullname: Nakagawa, Yoshihisa – sequence: 10 givenname: Yutaka surname: Furukawa fullname: Furukawa, Yutaka – sequence: 11 givenname: Tomohisa surname: Tada fullname: Tada, Tomohisa – sequence: 12 givenname: Kazuya surname: Nagao fullname: Nagao, Kazuya – sequence: 13 givenname: Kazushige surname: Kadota fullname: Kadota, Kazushige – sequence: 14 givenname: Mamoru surname: Toyofuku fullname: Toyofuku, Mamoru – sequence: 15 givenname: Takeshi surname: Kimura fullname: Kimura, Takeshi |
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