the risk balance of thrombotic and bleeding events after percutaneous coronary
intervention (PCI) is especially relevant for patients at high bleeding risk
(HBR). In 2019, the Academic Research Consortium for HBR (ARC-HBR) proposed a
consensus definition of HBR in an effort
to standardize the patient population involved. CERC organized the meetings of
the ARC-HBR group. This finally led to the presentation of the consensus
document at EuroPCR 2019 and to
the simultaneous publication in Circulation and the European Heart Journal.
The second initiative from the ARC-HBR is to produce a second consensus document and thus propose recommendations to guide the design of clinical trials of devices and drugs in HBR patients undergoing PCI. Two meetings of the ARC-HBR group took place in Washington, DC, USA, in April 2019, and Paris, France, in October 2019, once again organized by CERC and attended by the same experts from Europe, the USA and Asia, as well as representatives from the US FDA, the Japanese PMDA, a European Notified Body (DEKRA Certification BV, Arnhem, the Netherlands), and observers from the cardiovascular device and pharmaceutical industries. The output of the meetings will be published soon. The authors hope that this second document will promote consistency in trial design across a potential spectrum of applications in HBR patients, including evaluation of novel technologies and iterations of existing devices. This context is particularly important for the ARC-HBR definitions, which are intended for use in patients who have historically been under-represented in device and drug studies, and for whom there is a need for further understanding of both device and drug benefit/risk.