Validation of the ARC-HBR criteria in 68,874 patients undergoing PCI: A systematic review and meta-analysis.

The Academic Research Consortium High Bleeding Risk (ARC-HBR) criteria aims to stratify patients undergoing percutaneous coronary intervention (PCI) and are now recommended by international guidelines to stratify bleeding risk in clinical practice. We searched electronic databases from 2019 (ARC-HBR proposal) up to February 2021 for studies that reported the occurrence of major bleedings according to ARC-HBR status in patients undergoing PCI and pooled them as relative risk (RR) in a random-effect analysis. Only studies that reported events according to the number of times the ARC-HBR definition was met were included in a sensitivity analysis and RR for each stratum was calculated. Nine studies and 68,874 subjects were included in our analysis; 39.2% of them were at HBR and they had a significantly higher risk of major bleedings (RR: 2.70; 95% CI: 2.35-3.10; p < 0.0001). The ARC-HBR definition also had a moderate discriminative power (pooled c-stat: 0.69; 95% CI: 0.61-0.75) while calibration was suboptimal with a tendency toward underpredicting bleeding events (pooled observed:expected ratio: 1.47; 95% CI: 0.82-2.60). Our sensitivity analysis included 5 studies and 46,712 patients and confirmed the incremental, additive power of the ARC-HBR when it is met multiple times. Finally, among baseline characteristics explored, only presenting with an acute coronary syndrome had a significant impact on the ARC-HBR predictive ability. The ARC-HBR definition is a useful clinical tool, but with a tendency towards underpredicting major bleedings and its predictive ability might be optimized by including the number of times the definition is met.