Photo by Frank C. Muller
Results of a large meta-analysis indicate that bivalirudin may not be appropriate thromboprophylaxis for patients undergoing percutaneous coronary intervention (PCI).
Investigators found that bivalirudin was associated with an increased risk of stent thrombosis, when compared to an active control group.
Bivalirudin did confer a lower risk of major bleeding and cardiac death than the other anticoagulants studied.
But the drug had “no discernible impact” on all-cause mortality, according to the investigators.
“The take-home message is that, essentially, we didn’t find a net benefit with bivalirudin,” said Behnood Bikdeli, MD, of Yale-New Haven Hospital in Connecticut.
He and his colleagues detailed this discovery in Thrombosis Research.
The team analyzed data from 25 trials involving 41,243 PCI patients. The trials compared bivalirudin to other anticoagulants—largely unfractionated heparin, with or without other agents.
Compared with the active control group, bivalirudin use was associated with a significantly increased risk of definite stent thrombosis (risk ratio[RR]=1.73, P<0.001) and a significantly decreased risk of major bleeding (RR=0.59, P<0.001) and cardiac death (RR=0.72, P=0.05).
The risk of acute myocardial infarction was similar between the 2 groups (RR=1.00, P=0.96), as was the risk of all-cause mortality (RR=0.96, P=0.69).
The investigators said these results were consistent across a wide set of subgroup and sensitivity analyses.
“In our extensive analyses, we could not identify any patient subgroups that had less bleeding but no increase in the risk of clots, or stent thrombosis [with bivalirudin],” Dr Bikdeli said.
“This expensive medication, which is being used in a widespread manner, is not doing a slam-dunk better job. We might need more studies to see if a select minority of patients could potentially fare better with it.”
