2 The technology
2.1 Bivalirudin (Angiox, The Medicines Company) has a marketing authorisation 'as an anticoagulant in adult patients undergoing percutaneous coronary intervention (PCI), including patients with ST-segment-elevation myocardial infarction (STEMI) undergoing primary PCI'. This indication is an extension of the original indication and was approved in November 2009. The summary of product characteristics (SPC) states that bivalirudin should be administered with aspirin and clopidogrel.
2.2 According to the SPC, a very common adverse event associated with bivalirudin treatment is bleeding, which can occur anywhere in the body. Common adverse events are thrombosis (blood clots) and bleeding and bruising at the puncture site (after PCI). Uncommon adverse events are allergic reactions such as hives (nettle rash), itching all over the body and tightness of the chest. For full details of side effects and contraindications, see the SPC.
2.3 Bivalirudin is administered by injection or infusion. It is available in vials containing 250 mg powder for reconstitution and dilution before injection or infusion. The recommended dose of bivalirudin for patients undergoing PCI is an intravenous bolus of 0.75 mg/kg body weight followed immediately by an intravenous infusion at a rate of 1.75 mg/kg body weight/hour for at least the duration of the procedure. The infusion may be continued for up to 4 hours after PCI according to clinical need. After cessation of the infusion at 1.75 mg/kg/hour, a reduced dose infusion of 0.25 mg/kg/hour may be continued for 4–12 hours as clinically necessary. Assuming one 250 mg vial is used per patient, the acquisition cost of treatment with bivalirudin is £310.00 (British national formulary [BNF] edition 61]), excluding VAT. Costs may vary in different settings because of negotiated procurement discounts.