UK NICE approves bivalirudin
MedWire News: Bivalirudin has been endorsed by the UK National Institute for Health and Clinical Excellence (NICE) for patients with ST segment-elevation myocardial infarction (STEMI) who are undergoing percutaneous coronary intervention (PCI).
The anticoagulant, known as Angiox in Europe and Angiomax in the USA, has been approved for use in combination with aspirin and clopidogrel in these patients.
The results of the HORIZONS-AMI trial, which compared bivalirudin in combination with aspirin and clopidogrel, with heparin used in conjunction with a glycoprotein IIb/IIIa inhibitor, showed that the rate of major adverse cardiovascular events was comparable in both groups, at 5.5% after 30 days, and 12% after 1 year.
However, all-cause mortality was significantly lower with bivalirudin therapy than with heparin therapy, occurring in 3.5% versus 4.8% of patients after 1 year of follow-up (p=0.037). Cardiac mortality was also significantly lower with bivalirudin therapy, occurring in 2.1% versus 3.8% of patients (p=0.005).
In addition, bivalirudin patients had a lower incidence of major bleeding events than heparin patients, at 5.1% versus 8.8% at 30 days, and 5.8% versus 9.2% at 1 year (p<0.0001 for both).
Bivalirudin is already used extensively in the UK, but the new endorsement means that primary care centers in England and Wales will be more likely to adopt it for STEMI patients undergoing PCI.
The NICE Health Technology Evaluation Center Director, Carole Longson, commented: "With the number of PCIs being carried out increasing each year, this guidance provides the NHS in England and Wales with another important tool to enable it to treat patients who have had a heart attack more effectively."
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By Piriya Mahendra