Safety and Efficacy of Prolonged Use of Bivalirudin 4 Hours After ePCI (COBER Study)
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
Since the development of percutaneous coronary intervention (PCI) in patients with coronary
heart disease (CHD), unfractionated heparin (UFH) and low molecular weight heparin (LWMH)
have been the preferred anticoagulants in peri-operative period. However, UFH has some
defects, such as incomplete and unstable inhibition of thrombin, large individual
differences, multiple monitoring of activated coagulation time (ACT), ineffective thrombin
binding to fibrin, non-specific protein binding and induced thrombocytopenia (HIT). Compared
with UFH, LWMH has lower non-specific protein binding rate, but it is not superior to UFH in
efficacy, hemorrhage and HIT.
Bivalirudin can bind specifically to thrombin catalytic site and anionic external binding
site, directly inhibit thrombin activity, thereby inhibiting thrombin-catalyzed and induced
reactions. At the same time, thrombin can also inactivate it by enzymatic hydrolysis of
bivalirudin. Therefore, the inhibition of bivalirudin on thrombin is reversible and
transient, and the risk of bleeding after drug withdrawal is relative small. It has been
reported that bivalirudin can significantly reduce the risk of peri-operative bleeding during
PCI period compared with UFH. Clopidogrel had not yet played a role in most patients after
emergency PCI, and there was a "blank period" for 2-4 hours without effective antithrombotic
concentration, which was also the peak period of acute stent thrombosis. Han and coworkers
have shown that for acute myocardial infarction (AMI) patients undergoing emergency PCI,
whether or not glycoprotein IIb/IIIa inhibitors were added, prolonged peri-operative use of
bivalrudin was significantly better than UFH in terms of net clinical adverse event. However,
for patients with elective PCI (ePCI), prolonged bivalirudin use was only used in some
patients in REPLACE-2 and ISAR-REACT-3 studies, and the prolonged time of bivalrudin use
after ePCI was not definite.
Therefore, in the current study we aim to explore the efficacy and safety of prolonged
bivalirudin use 4 hours after elective PCI in patients with CHD.
Phase:
N/A
Details
Lead Sponsor:
Nanjing First Hospital, Nanjing Medical University