Defining High Bleeding Risk in Patients Undergoing Percutaneous Coronary Intervention - Aix-Marseille Université Accéder directement au contenu
Article Dans Une Revue Circulation Année : 2019

Defining High Bleeding Risk in Patients Undergoing Percutaneous Coronary Intervention

Philip Urban
  • Fonction : Auteur
Pedro Eerdmans
  • Fonction : Auteur
Michael Haude
  • Fonction : Auteur
Stefan James
  • Fonction : Auteur
Takeshi Kimura
  • Fonction : Auteur
Olivier Varenne

Résumé

Identification and management of patients at high bleeding risk undergoing percutaneous coronary intervention are of major importance, but a lack of standardization in defining this population limits trial design, data interpretation, and clinical decision-making. The Academic Research Consortium for High Bleeding Risk (ARC-HBR) is a collaboration among leading research organizations, regulatory authorities, and physician-scientists from the United States, Asia, and Europe focusing on percutaneous coronary intervention–related bleeding. Two meetings of the 31-member consortium were held in Washington, DC, in April 2018 and in Paris, France, in October 2018. These meetings were organized by the Cardiovascular European Research Center on behalf of the ARC-HBR group and included representatives of the US Food and Drug Administration and the Japanese Pharmaceuticals and Medical Devices Agency, as well as observers from the pharmaceutical and medical device industries. A consensus definition of patients at high bleeding risk was developed that was based on review of the available evidence. The definition is intended to provide consistency in defining this population for clinical trials and to complement clinical decision-making and regulatory review. The proposed ARC-HBR consensus document represents the first pragmatic approach to a consistent definition of high bleeding risk in clinical trials evaluating the safety and effectiveness of devices and drug regimens for patients undergoing percutaneous coronary intervention.
Fichier principal
Vignette du fichier
CIRCULATIONAHA.119.040167.pdf (373.16 Ko) Télécharger le fichier
Origine : Fichiers éditeurs autorisés sur une archive ouverte
Loading...

Dates et versions

hal-02542119 , version 1 (14-04-2020)

Licence

Paternité - Pas d'utilisation commerciale - Pas de modification

Identifiants

Citer

Philip Urban, Roxana Mehran, Roisin Colleran, Dominick Angiolillo, Robert Byrne, et al.. Defining High Bleeding Risk in Patients Undergoing Percutaneous Coronary Intervention. Circulation, 2019, 140 (3), pp.240-261. ⟨10.1161/CIRCULATIONAHA.119.040167⟩. ⟨hal-02542119⟩
153 Consultations
235 Téléchargements

Altmetric

Partager

Gmail Facebook X LinkedIn More