Validation of the ARC-HBR criteria in 68,874 patients undergoing PCI: A systematic review and meta-analysis
Related Experiment Video
Updated: Oct 24, 2026

Intracoronary Acetylcholine Provocation Testing for Assessment of Coronary Vasomotor Disorders
Published on: August 18, 2016
Claudio Montalto1, Andrea Raffaele Munafò2, Luca Arzuffi2
1Department of Molecular Medicine, University of Pavia, Pavia, Italy; De Gasperis Cardio Center, Interventional Cardiology Unit, Niguarda Hospital, Milan, Italy.
Insights
The Academic Research Consortium High Bleeding Risk (ARC-HBR) criteria identify patients at higher risk for major bleeding after percutaneous coronary intervention (PCI). While useful, the criteria tend to underpredict bleeding events, suggesting potential for optimization.
Area of Science:
- Cardiology
- Clinical Risk Stratification
- Interventional Cardiology
Background:
- The Academic Research Consortium High Bleeding Risk (ARC-HBR) criteria are recommended by international guidelines for stratifying bleeding risk in patients undergoing percutaneous coronary intervention (PCI).
- Accurate bleeding risk assessment is crucial for optimizing antithrombotic therapy and patient management post-PCI.
Purpose of the Study:
- To evaluate the real-world performance of the ARC-HBR criteria in predicting major bleeding events in patients undergoing PCI.
- To assess the discriminative power and calibration of the ARC-HBR definition and explore factors influencing its predictive ability.
Main Methods:
- A systematic search of electronic databases was conducted for studies published from 2019 to February 2021 that reported major bleeding events based on ARC-HBR status in PCI patients.
- A random-effect meta-analysis was performed to pool relative risks (RR) of major bleeding. A sensitivity analysis examined the impact of meeting the ARC-HBR definition multiple times.
- Pooled measures of discrimination (c-statistic) and calibration (observed:expected ratio) were calculated.
Main Results:
- Nine studies encompassing 68,874 patients were included. Patients meeting ARC-HBR criteria (39.2%) had a significantly higher risk of major bleeding (RR: 2.70).
- The ARC-HBR definition demonstrated moderate discriminative power (c-stat: 0.69) but suboptimal calibration, tending to underpredict bleeding events (O:E ratio: 1.47).
- Sensitivity analysis confirmed an incremental risk with multiple ARC-HBR criteria fulfillment. Acute coronary syndrome presentation was the only baseline characteristic significantly impacting predictive ability.
Conclusions:
- The ARC-HBR criteria are a valuable tool for identifying high bleeding risk in PCI patients, associated with a substantially increased risk of major bleeding.
- The criteria exhibit moderate discrimination but tend to underpredict bleeding events, indicating a need for refinement.
- Optimizing the predictive accuracy of the ARC-HBR criteria may involve incorporating the number of criteria met and considering baseline clinical factors like acute coronary syndrome.
Abstract:
The Academic Research Consortium High Bleeding Risk (ARC-HBR) criteria aims to stratify patients undergoing percutaneous coronary intervention (PCI) and are now recommended by international guidelines to stratify bleeding risk in clinical practice. We searched electronic databases from 2019 (ARC-HBR proposal) up to February 2021 for studies that reported the occurrence of major bleedings according to ARC-HBR status in patients undergoing PCI and pooled them as relative risk (RR) in a random-effect analysis. Only studies that reported events according to the number of times the ARC-HBR definition was met were included in a sensitivity analysis and RR for each stratum was calculated. Nine studies and 68,874 subjects were included in our analysis; 39.2% of them were at HBR and they had a significantly higher risk of major bleedings (RR: 2.70; 95% CI: 2.35-3.10; p < 0.0001). The ARC-HBR definition also had a moderate discriminative power (pooled c-stat: 0.69; 95% CI: 0.61-0.75) while calibration was suboptimal with a tendency toward underpredicting bleeding events (pooled observed:expected ratio: 1.47; 95% CI: 0.82-2.60). Our sensitivity analysis included 5 studies and 46,712 patients and confirmed the incremental, additive power of the ARC-HBR when it is met multiple times. Finally, among baseline characteristics explored, only presenting with an acute coronary syndrome had a significant impact on the ARC-HBR predictive ability. The ARC-HBR definition is a useful clinical tool, but with a tendency towards underpredicting major bleedings and its predictive ability might be optimized by including the number of times the definition is met.
More Related Videos
05:41Left Anterior Descending Coronary Artery Ligation for Ischemia-Reperfusion Research: Model Improvement via Technical Modifications and Quality Control
Published on: December 16, 2022
06:16Signal Acquisition, Score Interpretation, and Economics of a Non-Invasive Point-of-Care Test for Coronary Artery Disease
Published on: August 9, 2024
Related Concept Videos
Coronary Artery Disease V: Interprofessional Care
Acute Coronary Syndrome III: Diagnostic Studies
Peripheral Arterial Disease II: Clinical Manifestations and Diagnostic Evaluation