Bivalirudin: Treatment Effect Versus Side Effect

Abstract

Alexopoulos et al. 1 presented interesting data showing that in “real-life” scenario, there are no differences in one-month outcome between bivalirudin- and no bivalirudin-treated patients. When talking about bivalirudin efficacy, we have to consider two distinct features: treatment effect (antithrombotic action) and side effect (bleeding events). In HORIZONS-AMI trial, there was a reduction in cardiac mortality in the bivalirudin group that can only partly be attributed to prevention of bleeding 2. Notwithstanding, in EUROMAX trial, there was a substantial decline in bleeding events which did not transfer into survival benefit 3. Repeatedly, however, there was a higher incidence of stent thrombosis and a trend toward a higher incidence of myocardial infarction 3, 4, despite investigators' attempts to prevent it by prolonging bivalirudin infusion to 4 h following PCI. So actually, in terms of treatment effect, the study proved the drug not to be so efficacious. Bleeding events are independently associated with a worse long-term prognosis across a wide spectrum of patients with coronary artery disease and the risk of death progresses with increasing severity of bleeding 5, 6. However, in this instance, it would seem that we have decreased the risk of side effects (excellent safety profile) at the trade-off of increasing the risk of thrombotic events – events that, one would expect, should decline using antithrombotic agent 7. In addition, the cost of bivalirudin far exceeds that of standard treatment, thereby calling into question the ancillary benefits of the drug that would justify its use in place of the conventional regimen. Accordingly, we emphasize caution when talking about therapeutic effect. Until then, findings should be considered signals warranting further investigation. The authors declare no conflict of interest.