Safety and Efficacy of Bivalirudin in Female Acute Coronary Syndrome Patients Undergoing Percutaneous Coronary Intervention.

Abstract

Being women is an independent predictor of adverse events during percutaneous coronary intervention (PCI). Whether newer anticoagulant bivalirudin is safe and effective in female acute coronary syndrome (ACS) patients undergoing PCI, as compared with conventional heparin, is less well defined in Bangladeshi population. Our aim was to evaluate safety and efficacy of Bivalirudin in female ACS patients undergoing PCI. One hundred (100) female ACS patients were enrolled in this randomized controlled study, which underwent PCI from May to November, 2019 at BSMMU. Among them 35 patients were randomly assigned to receive bivalirudin and 65 patients were in control group to receive heparin with or without eptifibatide (GPI, glycoprotein IIb/IIIa inhibitor). The outcome measures were incidence of 30-day hemorrhagic complications, stent thrombosis and major adverse cardiac and cerebral events (MACCEs). Bivalirudin treatment was associated with significantly lower incidences of 30-day net adverse clinical events (NACEs) (5.7% vs. 27.6%, p=0.009) and bleeding (2.8% vs. 16.9%, p=0.03) compared with the control regimen. The incidence of MACCEs (2.8% vs. 15.4%, p=0.05) and stent thrombosis (0.0% vs. 3.1%, p=0.295) were comparable between the two groups. Multivariate analysis showed that bivalirudin (OR: 0.264, 95% CI: 0.071-0.977, p=0.04), trans-radial access (OR: 0.056, 95% CI: 0.003-0.967, p=0.04) and statin (OR: 0.009, 95% CI: 0.0005-0.168, p=0.001) were independent protective factors for 30-day NACEs. Bivalirudin is safe and effective in female ACS patients undergoing PCI as it reduces hemorrhagic complications without increase ischemic events (MACCEs) as compared with conventional heparin.