Validation of a high bleeding risk definition in cancer patients undergoing percutaneous coronary intervention

Aims Due to the absence of validated bleeding risk tools in cancer patients undergoing percutaneous coronary intervention (PCI), we aimed to validate an adapted version of the Academic Research Consortium (ARC) High Bleeding Risk (HBR) criteria. Methods and results Consecutive patients with active or remission cancer undergoing PCI between 2012 and 2022 at Mount Sinai Hospital (New York, USA) were included. Patients were considered at HBR if they met at least one of the major ARC-HBR criteria, other than cancer, or two minor criteria. The primary endpoint was a composite of periprocedural in-hospital or post-discharge bleeding at 1 year. The key secondary endpoint was major adverse cardiac and cerebrovascular events (MACCEs), including death, myocardial infarction, or stroke. Of the 2007 cancer patients included in this study, 1142 (56.9%) were classified as HBR. Moderate to severe anaemia was the most prevalent major HBR criterion (35%). At 1 year, the incidence of bleeding was significantly higher in HBR compared with non-HBR patients [10.9 vs. 3.9%, adjusted hazard ratio (HR): 2.36, 95% confidence interval (CI): 1.57-3.53, P < 0.001], mainly driven by higher periprocedural bleeding. Similarly, HBR patients were at higher risk of MACCE (11.0% vs. 3.2%, adjusted HR: 2.78, 95% CI: 1.72-4.47, P < 0.001) and death (8.8% vs. 2.2%, adjusted HR: 3.28, 95% CI: 1.87-5.77, P < 0.001) than non-HBR patients. Conclusion An adapted version of the ARC-HBR criteria, in which cancer is not a major criterion, effectively delineates cancer patients undergoing PCI who are at HBR. Cancer patients at HBR according to this definition also exhibited a higher mortality risk. Risk stratification at the time of percutaneous coronary intervention (PCI) is essential to tailor the choice of antithrombotic therapy at hospital discharge to the individual risk profile. While cancer patients are at higher risk of both bleeding and ischaemic events, few validated tools for bleeding risk stratification exist for these patients. In this study, we validated an adapted version of the widely used Academic Research Consortium (ARC) High Bleeding Risk (HBR) definition in cancer patients undergoing PCI. Unlike the original definition, the adapted version did not include cancer as a major criterion. The main findings of our study were the following: center dot Almost 60% of cancer patients were classified as HBR according to this definition. center dot High bleeding risk patients presented a significantly higher risk of bleeding and mortality up to 1 year after PCI, as compared with non-HBR patients. These findings support the use of the adapted ARC-HBR definition to guide the decision-making about antithrombotic therapy in cancer patients undergoing PCI. [GRAPHICS] .