Abstract 6191: Efficacy and Safety Assessment of Anticoagulation Strategies in Peripheral Percutaneous Intervention
Background: Anticoagulation strategies used in peripheral percutaneous intervention (PPI) are based primarily on percutaneous coronary intervention. In these studies, relatively higher doses of heparin were used, usually in combination with a GP IIb/IIIa agent. There are no studies comparing PPIs done with low-dose heparin alone versus bivalirudin in PPI. We compared the efficacy and safety (i.e. bleeding complications) of low-dose heparin versus bivalirudin in PPI.
Methods: We assessed prospectively 160 consecutive patients who underwent PPI from January through April 2008 during their index hospitalization for bleeding and thrombotic complications. Inclusion criteria included patients age >18 undergoing PPI for subclavian, renal or lower extremity arterial stenosis. Exclusion criteria included acute limb ischemia, use of fibrinolytic agents or GP IIb/IIIa antagonists, recent MI or CVA, and contraindication to heparin or bivalirudin. Out of 160 patients, 79 patients were dosed with heparin at 50 u/kg (goal ACT of 180 –225) and 81 patients were dosed with bivalirudin at 0.75 mcg/kg bolus followed by 1.75-mcg/kg infusion. Bivalirudin infusions were discontinued at the end of the procedure. Procedural success was defined as less than 30% post procedure residual stenosis. Major bleeding was defined as intracranial or retroperitoneal hemorrhage, or fall in Hgb ≥3 g/dl. All other bleeding was considered a minor bleed. In addition, anticoagulation cost analysis was conducted.
Results: Procedural success in 100% and 96.2% patients (p=NS) (no patient suffered acute vessel occlusion or any intraprocedural thrombotic complications), major bleeding occurred in 0% and 3.7% patients (p=NS), minor bleeding occurred in 5.1% and 11% patients (p=NS), who received heparin and bivalirudin, respectively. There was no statistical difference in time to sheath removal, time-to-ambulation, and length of hospital stay. The average charge to patients for heparin was $66, whereas the charge for bivalirudin was $2727.
Conclusion: Low-dose heparin is equally as safe and effective as bivalirudin in PPI. PPI with heparin is considerably more cost-effective than PPI with bivalirudin. Larger randomized studies are required to further evaluate this issue.