NICE gives thumbs up to bivalirudin for STEMI patients

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The National Institute for Health and Clinical Excellence (NICE) in the U.K. has recommended bivalirudin (Angiox in the EU/Angiomax in the U.S., The Medicines Company) in combination with aspirin and clopidogrel, for the treatment of STEMI patients undergoing PCI.

The decision is based on a review of cost-effectiveness and clinical efficacy data comparing the combination bivalirudin/aspirin or clopidogrel drug treatment with a combination of heparin and glycoprotein IIb/IIIa inhibitor (GPI), in combination with aspirin and clopidogrel (Plavix, Sanofi-Aventis/Bristol-Myers Squibb).

During the review, the appraisal committee said that data held “a very low degree of decision uncertainty and that bivalirudin should be recommended for the treatment of adults with STEMI undergoing PCI.”

Due to positive data, Primary Care Trusts (PCTs) in England and Wales are now encouraged to adopt bivalirudin for STEMI patients undergoing PCI, according to a press release from Parsippany, N.J.-based Medicines Company.

“With the number of PCIs being carried out increasing each year, this guidance provides the NHS (National Health Service) in England and Wales with another important tool to enable it to treat people who have had a heart attack more effectively,” Carole Longson, health technology evaluation centre director for NICE, said in a statement. “The independent committee that advises NICE considered that, on the basis of the available evidence, bivalirudin, in combination with clopidogrel and aspirin, is both more effective and less expensive than treatment with a glycoprotein inhibitor plus heparin. It is also associated with a lower incidence of major bleeding events compared with heparin and glycoprotein inhibitors."

Angiomax with provisional GPI is indicated for patients undergoing PCI and in patients at risk for heparin-induced thrombocytopenia and thrombosis syndrome. Additionally, the drug is indicated for use as an anticoagulant in patients undergoing percutaneous transluminal coronary angioplasty in the U.S. The drug is contraindicated in patients with active major bleeds of hypersensitivity to the drug.

Likewise, bivaluridin is approved as an anticoagulant for adult patients undergoing PCI, including STEMI patients in Europe. Additionally, the drug is indicated for the treatment of adult patients with unstable angina/non-STEMI MI.