PMID- 23102380 OWN - NLM STAT- MEDLINE DCOM- 20130708 LR - 20220318 IS - 0019-4832 (Print) IS - 0019-4832 (Linking) VI - 64 IP - 5 DP - 2012 Sep-Oct TI - Safety and efficacy of bivalirudin with glycoprotein IIb/IIIa for high-risk percutaneous coronary intervention. PG - 444-8 LID - S0019-4832(12)00098-3 [pii] LID - 10.1016/j.ihj.2012.07.022 [doi] AB - 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. CI - Copyright (c) 2012 Cardiological Society of India. All rights reserved. FAU - Deshpande, Niteen V AU - Deshpande NV AD - Spandan Heart Institute and Research Center, Nagpur, Maharashtra, India. FAU - Pratiti, Rebecca AU - Pratiti R FAU - Admane, Parag AU - Admane P FAU - Mukherjee, Debabrata AU - Mukherjee D FAU - Mardikar, Harshawardhan M AU - Mardikar HM LA - eng PT - Comparative Study PT - Journal Article PT - Randomized Controlled Trial DEP - 20120727 PL - India TA - Indian Heart J JT - Indian heart journal JID - 0374675 RN - 0 (Antithrombins) RN - 0 (Biomarkers) RN - 0 (Fibrinolytic Agents) RN - 0 (Hirudins) RN - 0 (Peptide Fragments) RN - 0 (Platelet Aggregation Inhibitors) RN - 0 (Platelet Glycoprotein GPIIb-IIIa Complex) RN - 0 (Recombinant Proteins) RN - 0 (Troponin I) RN - 42HK56048U (Tyrosine) RN - 9005-49-6 (Heparin) RN - GGX234SI5H (Tirofiban) RN - TN9BEX005G (bivalirudin) SB - IM MH - Aged MH - Antithrombins/adverse effects/*therapeutic use MH - Biomarkers/blood MH - Coronary Thrombosis/blood/etiology/*prevention & control MH - Drug Therapy, Combination MH - Female MH - Fibrinolytic Agents/adverse effects/*therapeutic use MH - Hemorrhage/chemically induced MH - Heparin/adverse effects/*therapeutic use MH - Hirudins/adverse effects MH - Humans MH - India MH - Male MH - Middle Aged MH - Myocardial Infarction/blood/etiology/prevention & control MH - Peptide Fragments/adverse effects/*therapeutic use MH - Percutaneous Coronary Intervention/*adverse effects MH - Platelet Aggregation Inhibitors/adverse effects/*therapeutic use MH - Platelet Glycoprotein GPIIb-IIIa Complex/*antagonists & inhibitors MH - Recombinant Proteins/adverse effects/therapeutic use MH - Time Factors MH - Tirofiban MH - Treatment Outcome MH - Troponin I/blood MH - Tyrosine/adverse effects/*analogs & derivatives/therapeutic use MH - Whole Blood Coagulation Time PMC - PMC3860907 EDAT- 2012/10/30 06:00 MHDA- 2013/07/09 06:00 PMCR- 2012/09/01 CRDT- 2012/10/30 06:00 PHST- 2012/04/24 00:00 [received] PHST- 2012/06/18 00:00 [revised] PHST- 2012/07/17 00:00 [accepted] PHST- 2012/10/30 06:00 [entrez] PHST- 2012/10/30 06:00 [pubmed] PHST- 2013/07/09 06:00 [medline] PHST- 2012/09/01 00:00 [pmc-release] AID - S0019-4832(12)00098-3 [pii] AID - 10.1016/j.ihj.2012.07.022 [doi] PST - ppublish SO - Indian Heart J. 2012 Sep-Oct;64(5):444-8. doi: 10.1016/j.ihj.2012.07.022. Epub 2012 Jul 27.