Nice endorses bivalirudin (Angiox) for heart attack patients

Angiox (bivalirudin), in combination with aspirin and clopidogrel, has been recommended by NICE for the treatment of adults with ST-segment-elevation myocardial infarction (STEMI or heart attack) undergoing emergency lifesaving procedures to unblock their coronary arteries (primary Percutaneous Coronary Intervention or "PCI"). The basis of this recommendation was a review of clinical and cost efficacy data comparing the bivalirudin strategy against a strategy of heparin with glycoprotein inhibitor in combination with aspirin and clopidogrel. PCTs in England and Wales will now be encouraged to adopt the bivalirudin strategy for STEMI patients undergoing primary PCI.

In its review the Appraisal Committee noted "the robustness of the clinical data, in which treatment with bivalirudin dominated treatment with a glycoprotein IIb/IIIa inhibitor plus heparin (that is, was less costly and more effective) and that the results of the model are robust to the various sensitivity analyses." The Committee concluded that "the model is associated with a very low degree of decision uncertainty and that bivalirudin should be recommended for the treatment of adults with STEMI undergoing PCI."

Supporting the positive NICE recommendation, Professor Anthony Gershlick, Interventional Cardiologist, University Hospitals of Leicester, commented: "In carrying out primary PCI we not only have the delicate task of clearing the blockage and, hopefully, saving the heart attack patient - we also have to deal with the concern that the life-saving anti-clotting drugs we are giving these sick patients during the procedure can potentially cause post-operative bleeding which is sometimes fatal. This is a routine concern in this type of patient."

The Medicines Company, manufacturer of bivalirudin, welcomes the decision by NICE which was made on the 'strength of evidence' for the drug. In a statement by NICE today, Dr Carole Longson, Health Technology Evaluation Centre Director said: "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 people who have had a heart attack more effectively. 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."

The NICE Final Appraisal Determination for bivalirudin for the treatment of adults with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention has been made final today for PCT implementation. NICE noted in its report that bivalirudin is already widely in use in the UK and both patients and clinicians are supportive of its continued use.