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Circulation
WHITE PAPER
Defining High Bleeding Risk in Patients
Undergoing Percutaneous Coronary Intervention
A Consensus Document From the Academic Research
Consortium for High Bleeding Risk
ABSTRACT: Identification and management of patients at high bleeding Philip Urban, MD
risk undergoing percutaneous coronary intervention are of major et al
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
D
o
w Food and Drug Administration and the Japanese Pharmaceuticals and
n
l
o
a Medical Devices Agency, as well as observers from the pharmaceutical
d
e
d and medical device industries. A consensus definition of patients at high
f
r
o bleeding risk was developed that was based on review of the available
m
h
t evidence. The definition is intended to provide consistency in defining this
t
p
:
/
/ population for clinical trials and to complement clinical decision-making
a
h
a
j and regulatory review. The proposed ARC-HBR consensus document
o
u
r
n represents the first pragmatic approach to a consistent definition
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