Paris, France, 22 May 2019. Identification and management of patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention (PCI) is of major importance, but a lack of standardisation in defining this population limits trial design, data interpretation, and clinical decision-making.
To address this issue, the Academic Research Consortium for High Bleeding Risk (ARC-HBR), an international group of physician-scientist experts in the field, regulatory authorities and leading research organisations, reviewed the available evidence and developed a consensus-based definition of patients at high bleeding risk after PCI. Fourteen major and six minor HBR criteria were defined.
Major criteria include the use of oral anticoagulation, severe or end-stage chronic kidney disease (eGFR < 30 ml/min), moderate or severe anaemia (haemoglobin <110 g/L), prior spontaneous bleeding requiring hospitalisation or transfusion during the prior 6 months (or at any time if recurrent), moderate or severe thrombocytopenia (< 100 x 109/L), chronic bleeding diathesis, liver cirrhosis with portal hypertension, active malignancy during the prior 12 months, prior spontaneous intracranial bleeding at any time, previous traumatic intracranial bleeding during the prior 12 months, known brain arteriovenous malformation, prior moderate or severe stroke during the prior 6 months, recent major surgery or trauma during the prior 30 days, and planned major surgery on DAPT.
Minor criteria include age ≥75, moderate chronic kidney disease (eGFR 30-59 ml/min), mild anaemia (haemoglobin 110-129 g/L for men and 110-119 g/L for women), spontaneous bleeding requiring hospitalisation and/or transfusion 6-12 months prior to PCI, chronic NSAID or steroid use, and ischaemic stroke more than 6 months prior to PCI.
Patients are considered to be at HBR if at least 1 major criterion or 2 minor criteria are satisfied.
The proposed ARC-HBR consensus document represents the first pragmatic approach to a definition of high bleeding risk for patients undergoing PCI. It is intended to provide consistency in defining this population for clinical trials and complement both clinical decision-making and regulatory review.
On Wednesday, May 22, the document will be published simultaneously in the European Heart Journal and in Circulation, at the time of presentation in the main arena during EuroPCR, and an app will be launched to help medical teams assess the bleeding risk at the bedside.
NOTES TO EDITORS
- A PCR statement on defining high bleeding risk in patients undergoing PCI: a consensus from the Academic Research Consortium for high bleeding risk presented by Philip Urban
- Palais des Congrès Porte Maillot - Paris, France
- Wednesday 22 May 2019 - 14:45 - Main Arena
- For more information see publication in European Heart Journal: Doi: 10.1093/eurheartj/ehz372
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