Expert OpinionVolume 76, Issue 12, September 2020
JOURNAL:J Am Coll Cardiol. Article Link
Trial Design Principles for Patients at High Bleeding Risk Undergoing PCI: JACC Scientific Expert Panel
D Capodanno, MC Morice, DJ Angiolillo et al.
Keywords:
trial design; high bleeding risk; PCI
ABSTRACT
Investigating the balance of risk for thrombotic and bleeding events
after percutaneous coronary intervention (PCI) is especially relevant
for patients at high bleeding risk (HBR). The Academic Research
Consortium for HBR recently proposed a consensus definition in an effort
to standardize the patient population included in HBR trials. The aim
of this consensus-based document, the second initiative from the
Academic Research Consortium for HBR, is to propose recommendations to
guide the design of clinical trials of devices and drugs in HBR patients
undergoing PCI. The authors discuss the designs of trials in HBR
patients undergoing PCI and various aspects of trial design specific to
HBR patients, including target populations, intervention and control
groups, primary and secondary outcomes, and timing of endpoint
reporting.