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 To validate the ARC definition for HBR in East Asian patients with ACS for invasive management.

METHODS We analyzed data from the TICAKOREA trial, 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 one major or two minor ARC-HBR criteria. The primary bleeding endpoint was Bleeding Academic Research Consortium (BARC) 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.

RESULTS Among 800 randomized patients, 129 (16.3%) were categorized HBR patients. HBR patients, compared to non-HBR patients, had a higher incidence of BARC 3 or 5 bleeding (10.0% vs. 3.7%; hazard ratio [HR], 2.98; 95% confidence interval [CI], 1.52–5.86; P < 0.001) and MACCE (14.3% vs. 6.1%; HR 2.35; 95% CI, 1.35–4.10; P = 0.002). 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.

JACC: Asia Editor-in-Chief 

Jian’an Wang, MD, PhD, FACC

CME Editor 

Kenneth A. Ellenbogen, MD

Authors
Rhanderson Cardoso, MD

Important Dates

Date of Release: June 6, 2023
Term of Approval/Date of CME/MOC Expiration: June 5, 2024