Key result
The Academic Research Consortium High Bleeding Risk (ARC-HBR) criteria identified approximately 15% of Korean ACS patients as high risk for both bleeding and thrombotic events (P=0.002).
Why the study?
The clinical applicability of the ARC-HBR criteria in East-Asian patients receiving potent antiplatelet therapy for ACS was undetermined.
Does ticagrelor compared to clopidogrel affect bleeding and ischemic outcomes in Korean ACS patients, and does the ARC-HBR definition accurately identify high-risk patients?
RCT (n=800)
1:1
Does ticagrelor compared to clopidogrel affect bleeding and ischemic outcomes in Korean ACS patients, and does the ARC-HBR definition accurately identify high-risk patients?
The ARC-HBR criteria successfully identify Korean ACS patients at high risk for both bleeding and thrombotic events.
Supports ARC-HBR use for bleeding risk stratification in East Asian ACS patients; confirms criteria validity in this population.
Background: Clinical applicability of the Academic Research Consortium High Bleeding Risk (ARC-HBR) criteria in East-Asian patients receiving potent antiplatelet therapy for acute coronary syndromes (ACS) is still undetermined. Objectives: The purpose of this study was to validate the ARC definition for HBR in East-Asian patients with ACS for invasive management. Methods: We analyzed data from the TICAKOREA (Ticagrelor Versus Clopidogrel in Asian/Korean Patients With ACS Intended for Invasive Management) trial and randomly assigned 800 Korean ACS subjects to receive, in a 1:1 ratio, ticagrelor or clopidogrel. Patients were considered HBR if they met at least 1 major or 2 minor ARC-HBR criteria. The primary bleeding endpoint was Bleeding Academic Research Consortium 3 or 5 bleeding and the primary ischemic endpoint was a major adverse cardiovascular event (MACE) (a composite of cardiovascular death, myocardial infarction, or stroke) at 12 months. The relative treatment effect of ticagrelor or clopidogrel on primary bleeding and ischemic outcomes were different between each group. Conclusions: This study validates the ARC-HBR definition in Korean ACS patients. Approximately 15% of patients qualified as HBR patients who were at increased risk not only for bleeding but also for thrombotic events. The clinical application of ARC-HBR to determine the relative effect of different antiplatelet regiments should be further investigated. (Safety and Efficacy of Ticagrelor Versus Clopidogrel in Asian/KOREAn Patients with Acute Coronary Syndromes Intended for Invasive Management [TICA KOREA]; NCT02094963).
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Lee et al. (2023) conducted an RCT in Acute coronary syndromes (ACS) (n=800). Ticagrelor vs. Clopidogrel was evaluated on Bleeding Academic Research Consortium 3 or 5 bleeding and major adverse cardiovascular event (MACE) (composite of cardiovascular death, myocardial infarction, or stroke) at 12 months (p=0.002). The Academic Research Consortium High Bleeding Risk (ARC-HBR) criteria identified approximately 15% of Korean ACS patients as high risk for both bleeding and thrombotic events (P=0.002).
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