Original title: Heparin monotherapy or bivalirudin during percutaneous coronary intervention in patients with non-ST-segment elevation acute coronary syndromes or stable ischemic heart disease: results from the Evaluation of Drug-Eluting Stents and Ischemic Events registry. Reference: Bangalore S et al. CircCardiovascInterv. 2014;Epub ahead of print.
Bivalirudin compared to unfractionated heparin as monotherapy is associated with a lower risk of bleeding without increasing the risk of ischemic events including stent thrombosis in patients who receive angioplasty in the context of NSTE-ACS as those receiving angioplasty on a scheduled basis.
EVENT (Evaluation of Drug-Eluting Stents and Ischemic Events) registry enrolled 1480 patients with ACS and 3517 patients admitted to programmatically angioplasty between 2004 and 2007.
All angioplasties were performed with bivalirudin or heparin at the discretion of the interventionist. Propensity score among those admitted experiencing NSTE-ACS , leaving 518 patients in each group for the final analysis, no differences in terms of the composite of death or myocardial infarction (5.6 % versus 6.8 %, P = 0.45 ) or stent thrombosis ( 0.4 % versus 0 %, P = 0.47 ) was observed. Bivalirudin was associated with a 36 % lower risk in the combined in-hospital bleeding (bleeding related to clinically important access, major or minor TIMI bleeding or need for transfusion) with 6 % to heparin and 2.7 % for bivalirudin (p = 0.01). Compared with heparin monotherapy the number required to treat (NNT) was 30 patients with bivalirudin to prevent a bleeding event. Propensity score was also used among those admitted on a scheduled angioplasty, leaving 1031 patients in each group for the final analysis that found similar results to previous, but with an NNT of 53 instead of 30.
Conclusion
In patients experiencing an ACS or stable coronary artery disease who received coronary angioplasty, bivalirudin compared to unfractionated heparin as monotherapy was associated with a lower risk of bleeding without increasing the risk of ischemic events including stent thrombosis.
Editorial comment
The benefit with respect to the observed bleeding with bivalirudin, seems clear in acute patients in concordance with most of the published evidence. For scheduled patients, the margin is much smaller, and the cost benefit is more difficult to sustain. It is also important to note that 98.9% of patients in this registry were performed by femoral approach, which clearly benefited bivalirudin. A randomized study has not been published yet that evaluate bivalirudin versus heparin as monotherapy in stable patients receiving radial access.
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