Safety of bivalirudin versus unfractionated heparin in endovascular revascularization of peripheral arteries in short- and long-term follow-up

INTRODUCTION: Patients with peripheral artery disease (PAD) are considered as a high-risk group for hemorrhagic events. AIM: To assess the safety of bivalirudin vs. unfractionated heparin (UFH) in percutaneous peripheral interventions (PPI) in short- and long-term follow-up. MATERIAL AND METHODS: The retrospective single-center, observational study included 160 patients, undergoing PPI. Patients were divided into 2 groups based on the use of anticoagulation – unfractionated heparin (UFH group) or bivalirudin (Biv. group) – and observed up to 5 years. RESULTS: The UFH group consisted of 101 patients and the Biv. group consisted of 59. We registered the following end points during in-hospital observation: 1 death (0.63% Biv, p = 0.18), 12 hematomas at puncture site (0.63% Biv. vs. 7.05% UFH, p = 0.04), 2 pseudoaneurysms (1.27% UFH, p = 0.29), thrombosis (0.63% UFH, p = 0.45), 1 bleeding from puncture site (0.63% UFH, p = 0.45). The total number of hemorrhagic complications was 1.24% in the Biv. group and 8.07% in the UFH group (p = 0.04). During long-term follow-up of 65.7 ±36.4 months the all-cause mortality rate was higher in the Biv. group (8.59% Biv vs. 0% in UFH group, p = 0.009). Regression analysis showed that bivalirudin administration is a risk factor for increased mortality risk (p = 0.003, OR = 15, 95% CI: 3.3–107.8). CONCLUSIONS: Usage of UFH was associated with a higher number of hemorrhagic complications, especially hematomas at the puncture site in comparison to patients receiving bivalirudin.