Bivalirudin reduces bleeding risk compared with standard therapy in
coronory syndromes
Use of bivalirudin to treat acute coronary syndromes is as effective as standard drugs but reduces the risk of major bleeding, a study published last week suggests (New England Journal of Medicine 2006;355:2203).
In the acute catheterisation and urgent intervention triage strategy
(ACUITY) trial, 13,819 patients were enrolled into one of three treatment
groups: unfractionated
heparin or enoxaparin, combined with
a glycoprotein IIb/IIIa inhibitor, bivalirudin and a glycoprotein IIb/IIIa
inhibitor or
bivalirudin alone. Almost all patients received aspirin and most received
clopidogrel before angiography.
The trial investigators did not identify a significant reduction in ischaemic
events with bivalirudin, but they did show that the drug is as good as
heparin for this endpoint. And although bivalirudin alone had similar
rates of ischaemic complications, revascularisations or death as the
other groups, it had lower rates of major bleeding complications (3.0
per cent versus 5.7 per cent; P<0.001, relative risk 0.53, 95 per
cent confidence interval 0.43–0.65).
The study was supported by Nycomed, the manufacturer of bivalirudin.
The author of an accompanying editorial (ibid, p2249) points out that
patients assigned to bivalirudin monotherapy who were not pretreated
with clopidogrel had a significant increase in ischaemic events compared
with those treated with a glycoprotein IIb/IIIa inhibitor. “This
finding suggests, but does not prove conclusively, that patients treated
with bivalirudin monotherapy should be pretreated with clopidogrel.” |
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