Application of the Academic Research Consortium High Bleeding Risk Criteria in an All-Comers Registry of Percutaneous Coronary Intervention

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 majors: 49.9%, 2 majors: 30.6%, 1 major: 18.5%, ≥2 minors: 14.7%, and no-HBR: 6.6%, 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.

Monotherapy With Prasugrel After Dual-Antiplatelet Therapy for Japanese Percutaneous Coronary Intervention Patients With High Bleeding Risk ― A Prospective Cohort Study (PENDULUM mono Study) ―

“…14 Similar trends were observed in the CREDO-Kyoto study, in which the 5-year incidence of the primary bleeding endpoint increased with increasing number of ARC-HBR criteria. 24 Conversely, in patients with ACS, prior PAD, and malignancy, it might be better to consider the balance between the risk and benefits of de-escalation of antiplatelet therapy. In addition, this study confirmed that severe CKD, severe anemia, and heart failure are associated with both ischemic and bleeding events, which is consistent with previous studies in which CKD, anemia, and heart failure, among other factors, were found to be common predictors of both thrombotic and bleeding events.…”

Clinical outcomes of nonagenarians with acute myocardial infarction who undergo percutaneous coronary intervention

“…2,10,11,22 Patients with major bleeding may require discontinuation of antiplatelet therapy or experience haemodynamic changes and adverse effects of transfusion, all of which may lead to increased adverse outcomes such as MI, stroke, stent thrombosis, and death. 7,[22][23][24] However, the inhospital bleeding rate of nonagenarians remains unclear. This study showed that the inhospital major bleeding rate of nonagenarians with AMI undergoing PCI was as high as 15.6% and IABP or PCPS use is associated with this adverse event.…”

Antithrombotic Strategy for Patients with Acute Coronary Syndrome: A Perspective from East Asia

“…Twenty clinical variables were identified as major or minor criteria by consensus, supported by published evidence, and patients are considered to have HBR if at least one major or two minor criteria are met. A previous study from a Japanese all-comers registry (CREDO-Kyoto Registry Cohort-2) [ 26 ] demonstrated that the prevalence of patients with HBR was 43% and the cumulative incidence of major bleeding in patients in the HBR group was 10.4% at one year after PCI; this is much higher than the prevalence of 4% defined at the proposal of the ARC-HBR criteria. These results suggest that application of the ARC-HBR criteria can identify patients with HBR in Japanese clinical practice despite the different risk profiles for bleeding events between East Asian and Western populations [ 12 , 13 , 15 ].…”