Five Years After ARC-HBR's Global Introduction: A Prospective Validation Study in Egypt.

Abstract

Five years after the global introduction of the ARC-HBR criteria, prospective validation in real-world clinical settings has remained globally lacking. This study aims to prospectively assess the predictive utility of ARC-HBR criteria in an Egyptian percutaneous coronary intervention (PCI) population, describe contemporary bleeding patterns, and establish a regional reference for post-PCI major bleeding outcomes. This single-center study included 1,018 PCI patients treated at Alexandria Main University Hospital between March 2022 and August 2023. High bleeding risk (HBR) was defined as ≥1 major or ≥2 minor ARC-HBR criteria. The primary endpoint was major bleeding (BARC type 3 or 5), including in-hospital, post-discharge, and cumulative events. Secondary endpoints included ARC-HBR prevalence, individual criterion associations with bleeding, and overall predictive performance. HBR patients (44.6%) experienced significantly higher cumulative major bleeding rates (8.4% vs. 3.2%; HR = 2.8, p < 0.001). In-hospital bleeding was low (1.2%) with no significant group difference, while post-discharge bleeding was markedly higher in HBR patients (7.6% vs. 2.4%, p < 0.001). Mild anemia and chronic kidney disease (CKD) were the most common ARC-HBR criteria. Severe CKD, non-deferrable surgery on dual antiplatelet therapy (DAPT), and oral anticoagulation (OAC) were the strongest predictors of bleeding. ARC-HBR demonstrated moderate predictive performance (C-statistic = 0.682). In conclusion, this study provides the first prospective validation of ARC-HBR in Egypt. While ARC-HBR criteria effectively identify HBR patients, persistently high post-discharge and cumulative bleeding rates highlight the need for improved mitigation strategies in real-world, resource-limited healthcare systems.