Validation of the academic research consortium high bleeding risk definition in Thai PCI registry.

ABSTRACT

BACKGROUND: Bleeding following percutaneous coronary intervention (PCI) has important prognostic implications. The Academic Research Consortium (ARC) have identified a set of clinical criteria to standardize the definition of a high bleeding risk (HBR). Current study sought to externally validate the ARC definition for HBR patients in a contemporary real-world cohort. METHOD: This post hoc analysis included 22,741 patients undergoing PCI between May 2018 and August 2019 enrolled in Thai PCI Registry. The primary endpoint was the incidence of major bleeding at 12 months post index PCI. RESULTS: In total, 8678 (38.2%) and 14,063 (61.8%) patients were stratified to the ARC-HBR and non-ARC-HBR groups, respectively. Incidence of major bleeding was 3.3 and 1.1 per 1000 patients per month in the ARC-HBR group and the non-ARC-HBR group (HR 2.84 [95% CI 2.39-3.38]; p < 0.001). Advanced age and heart failure met the 1-year major criteria performance goal of ≥4% major bleeding. The impact of HBR risk factors was incremental. HBR patients also experienced significantly higher rates of all-cause mortality (19.1% versus 5.2%, HR 4.00 [95% CI 3.67-4.37]; p < 0.001) and myocardial infarction. The ARC-HBR score fairly performed in discriminating bleeding with C-statistic (95% CI) of 0.674 (0.649, 0.698). Updating the ARC-HBR by adding heart failure, prior myocardial infarction, non-radial access, female in the model significantly improved C-statistic of 0.714 (0.691, 0.737). CONCLUSIONS: The ARC-HBR definition could identify patients at increased risk not only for bleeding but also for thrombotic events, including all-cause mortality. Coexistence of multiple ARC-HBR criteria unveiled additive prognostic value.