Are the minor high bleeding risk criteria of the academic research consortium truly minor? Insights from a high-volume tertiary care pci centre

Abstract

Abstract Background The Academic Research Consortium (ARC) has recently published a consensus-based definition to identify patients at high bleeding risk (HBR), reflected by a BARC 3 or 5 bleeding rate of ≥4% at 1 year after percutaneous coronary intervention (PCI). The HBR criteria included in the definition are divided into minor and major categories, with patients deemed to be at HBR if they fulfill at least one major or two minor criteria. As a result, patients who present with only one minor criterion are categorized as non-HBR. Purpose To compare the differences in baseline characteristics and 1-year bleeding and ischaemic outcomes between non-HBR patients undergoing PCI that present with only one minor HBR criterion versus those that do not fulfill any HBR criteria. Methods The study population consisted of all consecutive patients who underwent PCI with stent implantation in a single high-volume centre from January 2014 to December 2017. Patients were classified as non-HBR if they did not fulfill at least one major or two minor ARC-HBR criteria. The outcomes of interest were major bleeding (composite of peri-procedural and post-discharge bleeding), all-cause death, and myocardial infarction (MI) at 1 year. The Kaplan-Meier method was used for time-to-event analyses, with comparative risks being assessed using Cox regression. Results Of the 9,623 patients included in the analysis, 5,345 were classified as non-HBR. Within the non-HBR patients, 2,078 (38.9%) presented with only one minor HBR criterion and 3,267 (61.1%) presented with no HBR criteria. Non-HBR patients with one minor criterion were more often female, significantly older, with a higher burden of comorbidities such as diabetes mellitus, hypertension and hyperlipidaemia, and more likely to have multivessel disease as well as a history of prior MI and revascularisation, while non-HBR patients with no criteria were more likely to be smokers and have a higher BMI. Distribution of the minor HBR criteria within the group presenting with one minor criterion are illustrated in the figure. Non-HBR patients with only one minor criterion had a numerically higher rate of major bleeding compared to non-HBR patients with no criteria (3.6% vs. 2.9%, p=0.09). While the rate of all-cause death was significantly higher in the group with only one minor criterion (1.2% vs. 0.4%, p=0.004), there was no difference in the rate of MI between the two groups (2.1% vs. 1.9%, p=0.83). Hazard ratios comparing the two groups are presented in the figure. Conclusions Non-HBR patients presenting with only one minor criterion had a numerically higher rate of post-PCI bleeding and significantly higher mortality compared to those without any criteria. Nonetheless, the major bleeding rates of both groups at 1 year were less than the 4% cutoff to qualify as HBR according to the ARC definition, thereby supporting their inclusion as “minor” criteria in the recent ARC-HBR definition. Figure 1 Funding Acknowledgement Type of funding source: None