Patients undergoing coronary stenting typically receive dual antiplatelet therapy (DAPT) for 6 to 12 months, consisting of a P2Y12 receptor inhibitor and aspirin. While DAPT reduces the risk of recurrent ischemic events, it also increases the risk of bleeding. In patients at high risk of bleeding, European and US guidelines recommend shortening the duration of DAPT or de-escalating therapy (switching from ticagrelor or prasugrel to clopidogrel, or using a P2Y12 inhibitor as monotherapy).
To identify patients at high bleeding risk, European Society of Cardiology guidelines recommend using either the ARC-HBR (Academic Research Consortium for High Bleeding Risk) definition or the PRECISE-DAPT (PREdicting bleeding Complications In patients undergoing Stent implantation and subsEquent Dual Anti Platelet Therapy) score. These risk stratification tools aim to identify patients for whom shorter or less intensive antiplatelet therapy may offer a favorable balance between absolute bleeding risk and ischemic risk.
In this study, we used the ARC-HBR definition and the PRECISE-DAPT score to identify high bleeding risk patients in a cohort undergoing angioplasty. We evaluated the rates of bleeding and ischemic events among patients categorized as high or low bleeding risk, and analyzed whether the observed risks matched the risks predicted by both tools.
The primary endpoint (PEP) was the type of bleeding predicted by each risk tool: BARC type 3 to 5 bleeding in the analyses using the ARC-HBR definition, and TIMI major or minor bleeding in the analyses using the PRECISE-DAPT score. The secondary endpoint (SEP) included TIMI major or minor bleeding in analyses using the ARC-HBR definition; BARC type 3 to 5 bleeding in analyses using the PRECISE-DAPT score; and intracranial bleeding, TIMI major bleeding, and ischemic events (a combination of myocardial infarction and ischemic stroke) in analyses of both tools.
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Out of 7562 patients, 27% (2004/7562) were categorized as high bleeding risk by ARC-HBR and 38% (2894/7562) by PRECISE-DAPT. A total of 22% (1696/7562) had discordant high-risk classifications when comparing both tools.
Compared to those without high risk, patients identified as high bleeding risk by ARC-HBR had a higher risk of BARC type 3 to 5 bleeding (1-year risk: 7.1% vs. 2.3%; hazard ratio [HR]: 3.21; 95% confidence interval [CI]: 2.47–4.17) and ischemic events (7.8% vs. 2.8%; HR: 2.96; 95% CI: 2.31–3.79). Patients classified as high risk by the PRECISE-DAPT score also showed a higher risk of TIMI major or minor bleeding (4.4% vs. 2.1%; HR: 2.17; 95% CI: 1.63–2.89) and ischemic events (6.2% vs. 2.7%; HR: 2.38; 95% CI: 1.85–3.05).
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The PRECISE-DAPT score underestimated bleeding risk at nearly all levels (mean absolute difference between observed and predicted 1-year risk: 1.1%; T1–T3: 0.8%–1.4%).
Conclusion
In this cohort of patients undergoing coronary stenting, there was substantial discordance in high bleeding risk categorization between the ARC-HBR definition and the PRECISE-DAPT score. While both tools identified patients at increased bleeding risk, these patients also had elevated ischemic risk. The observed bleeding risks were higher than those predicted by PRECISE-DAPT at nearly all score levels. Our study highlights the limited general applicability of the high-risk definitions recommended by clinical guidelines, as well as the need to develop more accurate scoring systems to support decision-making in real-world clinical practice.
Original Title: Discordance and Performance of the ARC-HBR and PRECISE-DAPT High Bleeding Risk Definitions After Coronary Stenting.
Reference: Carl-Emil Lim, MD et al JACCCardiovasc Interv.2025;18:637–650.
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