Novel Approaches for Preventing or Limiting Events (NAPLES III) Trial: Randomised Comparison of Bivalirudin Versus Unfractionated Heparin in Patients at High Risk of Bleeding Undergoing Elective Coronary Stenting Throught The Femoral Approach. Rationale and Design

Purpose Bivalirudin (Angiox, The Medicine’s Company, Parsippany, NJ), a synthetic direct thrombin inhibitor, when compared with standard antithrombotic therapy (including unfractionated heparin [UFH] alone or plus a glycoprotein IIb/IIIa inhibitor) determines a significant decrease of major and minor bleeding and similar protection against ischemic events both in elective and in urgent percutaneous coronary intervention (PCI). There is a lack of prospective clinical trial assessing the safety and the efficacy of bivalirudin compared with UFH alone in the subset of biomarker negative patients at high risk of bleeding undergoing to elective PCI through the femoral approach.