CKD severity and high bleeding risk in patients undergoing PCI: stage-specific validation of modified ARC-HBR criteria
F M Di Muro, S Sartori, A Oliva, N Procopi, Y Feng, P Krishnan, E Carrion, R Sharma, J Sweeny, J Suleman, P Moreno, G Dangas, A Kini, S Sharma, R MehranAbstract
Background
Chronic kidney disease (CKD) is associated with increased ischemic and bleeding risk in patients undergoing percutaneous coronary intervention (PCI). The Academic Research Consortium for High Bleeding Risk (ARC-HBR) classifies severe CKD as a major and moderate CKD as a minor criterion; however, the performance of modified ARC-HBR criteria within a CKD population remains uncertain.
Purpose
This study aimed to validate a modified version of the Academic Research Consortium High Bleeding Risk (ARC-HBR) criteria in PCI patients with CKD and to evaluate its prognostic performance according to CKD severity and HBR burden.
Methods
This retrospective study included consecutive PCI patients with baseline CKD (estimated glomerular filtration rate [eGFR] <60 mL/min/1.73m²) treated at a large tertiary care academic center in the United States between 2012 and 2022. Patients with cardiogenic shock, cardiac arrest, or missing follow-up data were excluded. HBR status was defined according to ARC-HBR criteria, excluding moderate and severe CKD to avoid circular risk attribution. The primary endpoint was 1-year bleeding (in-hospital or post-discharge). The key secondary outcome was major adverse cardiovascular events (MACE), defined as all-cause death, myocardial infarction (MI), or stroke. Associations between HBR status and outcomes were assessed using Cox proportional hazards models adjusted for baseline variables showing significant imbalance between groups. Stratified analyses of endpoints were performed according to CKD severity based on eGFR (moderate CKD [30–59 mL/min/1.73m²] and severe CKD [<30 mL/min/1.73m²]).
Results
Among 7,388 CKD patients undergoing PCI, 4,320 (58.5%) met the modified ARC-HBR definition. Moderate-to-severe anemia was the most prevalent major criterion, while age >75 years was the most common minor criterion. Compared with non-HBR patients, those classified as HBR were older, more frequently female, and had a greater burden of comorbidities. At 1 year, HBR status was associated with a significantly higher risk of bleeding (10.5% vs. 4.5%; HR 2.21, 95% CI 1.83–2.67; p<0.001), predominantly driven by in-hospital events, as well as a 2.15-fold increased risk of MACE, largely due to all-cause mortality and spontaneous MI. Stratified analyses according to CKD severity demonstrated differential prognostic patterns: in moderate CKD, modified HBR criteria preserved strong discrimination for both bleeding and ischemic outcomes; conversely, in severe CKD, bleeding risk remained elevated, whereas incremental discrimination for ischemic outcomes was attenuated (Figure).
Conclusion
In PCI patients with CKD, a modified ARC-HBR definition excluding renal impairment provides effective risk stratification. Importantly, its stage-specific performance supports the classification of severe CKD as a major and moderate CKD as a minor ARC-HBR criterion.FigureFor image description, please refer to the figure legend and surrounding text.