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Standard Definition Proposed for High Bleeding Risk in PCI

PARIS — A group took the first step to standardizing what it means for a percutaneous coronary intervention (PCI) candidate to be at “high bleeding risk.”

This is when BARC 3 or 5 bleeding risk is at least 4% and/or when the risk of intracranial hemorrhage is at least 1% within a year of the procedure, according to Philip Urban, MD, of Hôpital de la Tour in Geneva, on behalf of the Academic Research Consortium for High Bleeding Risk (ARC-HBR).

Patients can have just one of the following to meet the threshold for high bleeding risk, Urban said during a press conference at the EuroPCR meeting:

  • Impaired kidney function (eGFR <30 ml/min)
  • Active cancer in the past 12 months
  • Low platelet count
  • Long-term oral anticoagulant use after PCI
  • Anemia with hemoglobin <110 g/L

The full list of criteria was published online in Circulation.

Without a standard definition of high bleeding risk, the stenting literature had suffered from limited generalizability and poolability of data.

“While this ARC-HBR definition will require both validation and probable recalibration as data accrue, we believe it provides a much-needed framework for understanding and evaluating treatment options for PCI patients at increased bleeding risk,” the presenter said.

Instead of having one of the aforementioned major criteria, patients may be deemed at high bleeding risk if they have two of the following minor criteria:

  • Age 75 or older
  • Milder or less recent stroke history
  • Chronic nonsteroidal anti-inflammatory drug or steroid use after PCI
  • Anemia with reduced hemoglobin (<130 g/L for men, <120 g/L for women)

“Currently, physicians are making decisions on intensity and duration of antiplatelet therapy using variables such as clinical indication for PCI (stable angina vs acute coronary syndrome) or stent type. A more personalized approach incorporating bleeding risk with the ARC HBR will need to be compared to other bleeding risk scores such as PRECISE DAPT in PCI,” J. Dawn Abbott, MD, of Warren Alpert Medical School at Brown University in Providence, Rhode Island, told MedPage Today.

Potential risk factors that wound up not making it to the list of high bleeding risk criteria included acute coronary syndrome presentation, frailty, and race, Urban said.

Nevertheless, Cindy Grines, MD, of Northwell Health in Hempstead, New York, said that the existing criteria “seem very reasonable.”

They can help operators determine which individuals should be excluded from PCI altogether and which might benefit from bleeding risk-reducing strategies, she said, adding that these strategies include radial access, femoral vascular closure device use, avoidance of strong antithrombotics, and use of intracoronary imaging to allow for early discontinuation of dual antiplatelet therapy.

A smartphone app is available to help clinicians determine if PCI candidates are at high bleeding risk according to the ARC-HBR.

The project was organized by the European Cardiovascular Research Center (a contract research organization where Urban is a co-medical director) with financial support from industry.