Five Years After ARCHBR's Global Introduction: A Prospective Validation Study in Egypt

Five years after the global introduction of the ARCHBR criteria, prospective validation in real-world clinical settings has remained globally lacking. This study aims to prospectively assess the predictive utility of ARCHBR 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 ARCHBR criteria. The primary endpoint was major bleeding (BARC type 3 or 5), including in-hospital, postdischarge, and cumulative events. Secondary endpoints included ARCHBR 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 postdischarge 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 ARCHBR criteria. Severe CKD, nondeferrable surgery on dual antiplatelet therapy (DAPT), and oral anticoagulation (OAC) were the strongest predictors of bleeding. ARCHBR demonstrated moderate predictive performance (C-statistic = 0.682). In conclusion, this study provides the first prospective validation of ARCHBR in Egypt. While ARCHBR criteria effectively identify HBR patients, persistently high postdischarge and cumulative bleeding rates highlight the need for improved mitigation strategies in real-world, resource-limited healthcare systems.