Key result
Patients meeting the ARC-HBR criteria had a significantly higher cumulative incidence of major bleeding at 8 years compared to non-HBR patients (16.2% vs. 5.7%, HR 2.76).
Why the study?
The prevalence of individual ARC-HBR criteria and their prognostic value for long-term bleeding events after PCI were scarcely studied.
Does the ARC-HBR definition and a simplified version predict long-term major bleeding in patients undergoing PCI with everolimus-eluting stents?
Cohort (n=1,193)
No
Does the ARC-HBR definition and a simplified version predict long-term major bleeding in patients undergoing PCI with everolimus-eluting stents?
Hazard Ratio: 2.76 (95% CI 1.8–4.38)
Absolute Event Rate: 16.2% vs 5.7%
p-value: p=<0.0001
A simplified ARC-HBR definition excluding infrequent criteria successfully identifies patients at high risk for long-term bleeding after PCI, performing comparably to the original definition.
ARC-HBR criteria stratify long-term bleeding risk after PCI; leaves open whether simplified definition improves risk stratification in practice.
BACKGROUND: The Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria have been suggested as the standard definition of HBR. However, the prevalence of individual criteria and their prognostic value for long-term bleeding events after percutaneous coronary intervention are scarcely studied. METHODS AND RESULTS: The study population comprised 1,193 patients treated with everolimus-eluting stents between 2010 and 2011. Data on all 17 major and minor criteria of the ARC-HBR definition were retrospectively collected, and applied to this study population. Major bleeding was defined as the occurrence of a BARC type 3 or 5 bleeding event. A simplified definition was developed by excluding the low-frequency criterion, and the prognostic value was assessed by a receiver-operating characteristic curve. Mean follow-up was 2,996±433 days and there were 656 HBR patients (55.0%). The cumulative incidence of major bleeding was significantly higher in the HBR group than in the non-HBR group (16.2% vs. 5.7% at 8 years, P<0.001). The frequencies of 6 of the 17 criteria were less than 1%. The prognostic value of the simplified definition made by excluding these 6 criteria for major bleeding was comparable to that of the original (c-statistic=0.598 and 0.600, P=0.08). CONCLUSIONS: Some risk criteria of the ARC-HBR definition are observed infrequently. Our simplified definition identified patients with long-term bleeding risk as successfully as the original definition.
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Miura et al. (2020) conducted a cohort in Coronary artery disease requiring percutaneous coronary intervention (n=1,193). High Bleeding Risk (ARC-HBR criteria) vs. Non-High Bleeding Risk was evaluated on Major bleeding (BARC type 3 or 5 bleeding event) (HR 2.76, 95% CI 1.80-4.38, p=<0.0001). Patients meeting the ARC-HBR criteria had a significantly higher cumulative incidence of major bleeding at 8 years compared to non-HBR patients (16.2% vs. 5.7%, HR 2.76).
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