Abstract 1965: Bivalirudin and Proximal Endovascular Clamping for Carotid Artery Stenting
Background: The use of proximal endovascular clamping (PEC) led to a significant reduction of microembolization, during carotid artery stenting (CAS). This device requires a large femoral sheath. Sheath size is a strong predictor of bleeding after percutaneous procedures. The use of a direct thrombin inhibitor, Bivalirudin, reduces such complications after PCI.
Aim of the Study: To evaluate, in a randomized prospective study, safety and efficacy of bivaluridin vs. heparin during CAS, using PEC as distal protection device.
Methods: From december 2005 to may 2006, 90 consecutive patients undergoing CAS using PEC, have been randomly assigned to one of the study arm (Control Arm: 100 UI/Kg heparin or Bivaluridin arm: 0.75 mg/kg IV bolus of bivalirudin and infusion at 2.5mg/kg/h). Femoral sheaths were removed after 2 hours in the Bivaluridin arm and after 4 hours (assuming that ACT < 150 s) in the control arm.
Results: Procedural success was 100%, without any intraprocedural complications. In hospital MACCE included no deaths, no mayor strokes, 2 % of minor strokes and no AMI. No difference of MACCE was observed between the study groups. Post procedural haemoglobin drop was significatively lower in patients receiving bivaluridin (1,9 ± 0,2 g/dl vs 2,4 ± 0,1 g/dl; p < 0,05). When bivaluridin was administered, femoral sheaths could be safely removed two hours after the procedure, thus reducing the incidence of sheath induced leg ischemia.
Conclusions: The use of direct thrombin inhibitors is a safe and efficient anticoagulation regimen for CAS using PEC as a distal protection device. This treatment reduces post procedural haemoglobin loss and allows an earlier removal of the large femoral sheath. The clinical relevance of these data should be confirmed by multicenter randomized study.