Bivalirudin, a synthetic analogue of
hirudin, is a specific and reversible inhibitor of
thrombin which binds directly with both fluid-phase and clot-bound
thrombin. In patients with
unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA), results from a large well designed study and its reanalysis (n = 4312) indicate that
bivalirudin is more effective than
heparin in the prevention of ischaemic complications for up to 90 days after the start of treatment. In addition, among patients undergoing PTCA for post
myocardial infarction (MI)
bivalirudin may be more effective than
heparin in preventing ischaemic complications for up to 180 days
after treatment was started. Data from dose-finding studies indicate
bivalirudin has potential in the treatment of patients with
unstable angina not undergoing
percutaneous coronary intervention (PCI); however, well designed comparative studies are needed before firm conclusions can be made. Among patients with acute ST elevation MI, randomised trials have demonstrated
bivalirudin to be significantly more effective than
heparin in improving early patency in patients receiving
thrombolytic therapy with
streptokinase. Data from the
Hirulog and Early Reperfusion/Occlusion (HERO)-1 trial (n = 412) indicate that
bivalirudin recipients were significantly more likely to have
Thrombin Inhibition in Myocardial Ischaemia (TIMI) grade 3 flow at 90 to 120 minutes than
heparin recipients. In addition, data from the HERO-2 trial (n = 17 073) show
bivalirudin was significantly more effective than
heparin in reducing adjudicated 96-hour reinfarction and 30-day investigator-reported death/reinfarction than
heparin.
Bivalirudin was as effective as
heparin in reducing 30-day mortality. Data from a meta-analysis of four randomised trials among patients undergoing PTCA or treatment for
acute coronary syndromes indicate that, at after 30 to 50 days of follow-up,
bivalirudin was significantly more effective than
heparin in reducing the incidence of nonfatal MI and the combined endpoint of death or nonfatal MI. The most significant adverse events associated with
bivalirudin are
bleeding complications. In individual trials,
bivalirudin was as well tolerated as
heparin with, in general, a reduced incidence of
bleeding complications. Additionally,
bivalirudin provides a more consistent, predictable
anticoagulant response. In 4312 patients with
unstable angina undergoing PTCA the incidence of retroperitoneal
bleeding,
blood transfusion and major haemorrhage was significantly lower in
bivalirudin than
heparin recipients. Data from the HERO-2 trial in patients with acute MI indicate that although
bivalirudin recipients had a significantly higher incidence of mild or moderate
bleeding than
heparin recipients, there was no difference in intracranial haemorrhage, severe
bleeding or transfusions. Data from a meta-analysis among 5674 patients with ischaemic
heart disease show
bivalirudin recipients were at a significantly lower risk of haemorrhagic events than
heparin recipients.
CONCLUSIONS: