Bivalirudin Vs Heparin with Glycoprotein IIB/IIIA Blockade in Acute Coronary Syndrome (ACS) Patients Undergoing Percutaneous Coronary Revascularization: An Observational Study in Indian Patients

Abstract

Introduction: Currently either heparin or bivalirudin can be used during PCI as a class I indication as per PCI guidelines published by AHA in 2011. There are multiple randomized control trials e.g. HORIZONS-AMI, EUROMAX, REPLACE 2, ISAR-REACT 3, ACUITY which favors bivalirudin when compared with heparin in different clinical situations, but the role of bivalirudin during PCI has also been questioned in a recent large, open label randomized control trial, HEAT PPCI which showed higher incidence of acute stent thrombosis and significant bleeding in bivalirudin arm. Present study designed to observe clinical outcomes and adverse events for 30 days in post PCI patients. Material and Methods: A total of 124 patients were studied over a period of 6 months (May 2015-November 2015). Out of 124 patients, 61 received heparin with provisional planned glycoprotein IIb/IIIa (GPI) blockade and 63 received bivalirudin with provisional planned glycoprotein IIb/IIIa blockade. Baseline characteristics of the patients were well matched. Pre procedure aspirin and P2Y12 inhibitor was given to all patients. Glycoprotein IIb/IIIa inhibitor was given in 34.4% of patients in heparin group. No patient in the bivalirudin group received glycoprotein IIb/IIIa inhibitor. Main route of access was femoral (95.9%). Single vessel disease was seen in 70.96% of patients. Results: At time of discharge, MACE was observed in the two cases in the bivalirudin group (3.2%) while heparin group showed no MACE. Both MACE were attributed to mortalities. Major bleeding was seen in only one patient who received bivalirudin (1.6%). No case of cerebrovascular accident, reinfarction or unplanned target lesion, revascularization was observed in either group at time of discharge. At 30 days, one additional MACE happened in the form of definitive sub acute stent thrombosis in bivalirudin arm with no addition in heparin group. Total MACE at 30 days was 4.7% in bivalirudin group, while no MACE was observed in the heparin group. At 30 days, no additional major bleeding noted an in any of the arm. Conclusion: In this study we could not find any statistically significant difference in 30 days efficacy and safety outcome in two groups, one receiving bivalirudin with provisional planned glycoprotein IIb/IIIa blockade and other heparin with provisional planned glycoprotein IIb/IIIa blockade. Though there were 3 MACE and 1 major bleed in bivalirudin arm comparing with no such event in heparin arm but this difference was not statistically significant.