Bivalirudin vs Unfractionated Heparin during PCI in Patients with ACS without ST-Segment Elevation

Methods: In group I (n=155) - PCI was performed with Bivalirudin and group II (n=191) - with unfractionated heparin. Additional randomization of patients in group I: in subgroup A (n=77) - the bivalirudin infusion was continued for 4 hours after intervention and in the subgroup B (n=78) - infusion was discontinued in the CathLab.
Results: Serious bleeding (BARC 3 and 5) was significantly more often in patients from group II. The groups also did not differ in the incidence of acute stent thrombosis. In the subgroup A was less significant to have MACE, compared with patients from the subgroup B (1,3 and 13%, respectively; p=0.001), and the incidence of bleeding was also not significantly increased. Patients in group I with transradial arterial access, bleeding and MACE were 0 and 2.9%, respectively, while patients with transfemoral arterial access, these figures were significantly higher and was up to 3.3 and 10%, respectively (p<0.001). Similar trend was observed in the second group with transradial arterial access - 6 and 4.6%, respectively, while with transfemoral arterial access were 33.7 and 11.9%, respectively (p<0.001). The long term results of treatment (mean period of 18±1.14 months) were assessed in 192 patients The total incidences of MACE was significantly lower in group I compared to group II and was up to 2.2% and 6%, respectively (p=0,0312).
Conclusion: Bivalirudin during PCI in patients with ACS without ST-segment elevation, reduces the risk of hemorrhagic complications. The implementation of PCI by radial arterial access and the prolongation of the bivalirudin infusion for 4 hours after PCI are additional factors favorable for endovascular treatment of patients (ACS) without ST-segment elevation.