Validation of the ARC-HBR criteria in 68,874 patients undergoing PCI: A systematic review and meta-analysis

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.

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