ABSTRACT
AIMS: The aim of the study was to assess the safety and efficacy of bivalirudin + glycoprotein (Gp) IIb/IIIa inhibitor as compared to unfractionated heparin (UFH) + Gp IIb/IIIa inhibitor in high risk patients undergoing elective percutaneous coronary intervention (PCI). The primary end point was time to sheath removal and ambulation where as peri-procedure myocardial damage, access site bleeding and major adverse cardiac events (MACE) rates were secondary end points. METHODS: One hundred and one high risk patients undergoing elective PCI were randomly assigned to either bivalirudin + GpIIb/IIIa inhibitor or UFH + Gp IIb/IIIa inhibitor. PCI was performed by standard technique and activated clotting time was monitored immediately on arrival to recovery area and every 60 min thereafter. Sheath were pulled out once ACT was below 150 seconds and patients were mobilized 6hrs after sheath were removed. Peri-procedure myocardial damage was assessed by serial Trop I levels. RESULTS: Patient assigned to bivalirudin + tirofiban has significantly reduced time to sheath removal and ambulation as compared to those who received UFH + tirofiban (p < 0.0001) although peak Act did not differ in the groups. Peak Trop I levels were significantly lower in bivalirudin + tirofiban group (p = 0.023) and peri-procedure Trop I elevation occurred in significantly lower number of patients treated with bivalirudin + tirofiban (p = 0.029). CONCLUSIONS: The combination of bivalirudin + tirofiban was safe and effective as compared to UFH + tirofiban in high risk patients undergoing elective PCI.
Subject(s)
Antithrombins/therapeutic use , Coronary Thrombosis/prevention & control , Fibrinolytic Agents/therapeutic use , Heparin/therapeutic use , Peptide Fragments/therapeutic use , Percutaneous Coronary Intervention/adverse effects , Platelet Aggregation Inhibitors/therapeutic use , Platelet Glycoprotein GPIIb-IIIa Complex/antagonists & inhibitors , Tyrosine/analogs & derivatives , Aged , Antithrombins/adverse effects , Biomarkers/blood , Coronary Thrombosis/blood , Coronary Thrombosis/etiology , Drug Therapy, Combination , Female , Fibrinolytic Agents/adverse effects , Hemorrhage/chemically induced , Heparin/adverse effects , Hirudins/adverse effects , Humans , India , Male , Middle Aged , Myocardial Infarction/blood , Myocardial Infarction/etiology , Myocardial Infarction/prevention & control , Peptide Fragments/adverse effects , Platelet Aggregation Inhibitors/adverse effects , Recombinant Proteins/adverse effects , Recombinant Proteins/therapeutic use , Time Factors , Tirofiban , Treatment Outcome , Troponin I/blood , Tyrosine/adverse effects , Tyrosine/therapeutic use , Whole Blood Coagulation TimeABSTRACT
Management of acute myocardial infarction (AMI) in India essentially rests on the established reperfusion strategies with unique adaptations compelled by the socioeconomic structure of the country. Due to limited availability of trained interventionists coupled with financial limitations, thrombolysis remains the most utilised reperfusion therapy for AMI. Patient education through the active participation of physicians concerning the early detection of symptoms suggestive of AMI can enhance the impact of thrombolysis on the outcomes by narrowing the door-to-needle time. This article discusses some of these unique issues and possible solutions in the emerging economies to optimise outcomes in AMI.
