PMID- 11489769 OWN - NLM STAT- MEDLINE DCOM- 20010913 LR - 20190623 IS - 1524-4539 (Electronic) IS - 0009-7322 (Linking) VI - 104 IP - 6 DP - 2001 Aug 7 TI - Randomized comparison of enoxaparin, a low-molecular-weight heparin, with unfractionated heparin adjunctive to recombinant tissue plasminogen activator thrombolysis and aspirin: second trial of Heparin and Aspirin Reperfusion Therapy (HART II). PG - 648-52 AB - BACKGROUND: Adjunctive unfractionated heparin (UFH) during thrombolytic therapy for acute myocardial infarction (AMI) promotes the speed and magnitude of coronary artery recanalization and reduces reocclusion. Low-molecular-weight heparins offer practical and potential pharmacological advantages over UFH in multiple applications but have not been systematically studied as adjuncts to fibrinolysis in AMI. METHODS AND RESULTS: Four hundred patients undergoing reperfusion therapy with an accelerated recombinant tissue plasminogen activator regimen and aspirin for AMI were randomly assigned to receive adjunctive therapy for at least 3 days with either enoxaparin or UFH. The study was designed to show noninferiority of enoxaparin versus UFH with regard to infarct-related artery patency. Ninety minutes after starting therapy, patency rates (thrombolysis in myocardial infarction [TIMI] flow grade 2 or 3) were 80.1% and 75.1% in the enoxaparin and UFH groups, respectively. Reocclusion at 5 to 7 days from TIMI grade 2 or 3 to TIMI 0 or 1 flow and TIMI grade 3 to TIMI 0 or 1 flow, respectively, occurred in 5.9% and 3.1% of the enoxaparin group versus 9.8% and 9.1% in the UFH group. Adverse events occurred with similar frequency in both treatment groups. CONCLUSIONS: Enoxaparin was at least as effective as UFH as an adjunct to thrombolysis, with a trend toward higher recanalization rates and less reocclusion at 5 to 7 days. FAU - Ross, A M AU - Ross AM AD - Cardiovascular Research Institute, Institute of Medicine, George Washington University, Washington, DC, USA. allanmross@aol.com FAU - Molhoek, P AU - Molhoek P FAU - Lundergan, C AU - Lundergan C FAU - Knudtson, M AU - Knudtson M FAU - Draoui, Y AU - Draoui Y FAU - Regalado, L AU - Regalado L FAU - Le Louer, V AU - Le Louer V FAU - Bigonzi, F AU - Bigonzi F FAU - Schwartz, W AU - Schwartz W FAU - de Jong, E AU - de Jong E FAU - Coyne, K AU - Coyne K CN - HART II Investigators LA - eng PT - Clinical Trial PT - Clinical Trial, Phase II PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - United States TA - Circulation JT - Circulation JID - 0147763 RN - 0 (Anticoagulants) RN - 0 (Enoxaparin) RN - 0 (Heparin, Low-Molecular-Weight) RN - 0 (Recombinant Proteins) RN - 9005-49-6 (Heparin) RN - EC 3.4.21.68 (Tissue Plasminogen Activator) RN - R16CO5Y76E (Aspirin) SB - IM MH - Anticoagulants/adverse effects/*therapeutic use MH - Aspirin/*therapeutic use MH - Coronary Angiography MH - Coronary Circulation/drug effects MH - Enoxaparin/adverse effects/*therapeutic use MH - Female MH - Heparin/adverse effects/*therapeutic use MH - Heparin, Low-Molecular-Weight/adverse effects/therapeutic use MH - Humans MH - Intracranial Hemorrhages/chemically induced MH - Male MH - Middle Aged MH - Myocardial Infarction/*drug therapy/mortality/physiopathology MH - Myocardial Reperfusion MH - Recombinant Proteins/therapeutic use MH - Survival Rate MH - Thrombolytic Therapy MH - Tissue Plasminogen Activator/*therapeutic use MH - Treatment Outcome EDAT- 2001/08/08 10:00 MHDA- 2001/09/14 10:01 CRDT- 2001/08/08 10:00 PHST- 2001/08/08 10:00 [pubmed] PHST- 2001/09/14 10:01 [medline] PHST- 2001/08/08 10:00 [entrez] AID - 10.1161/hc3101.093866 [doi] PST - ppublish SO - Circulation. 2001 Aug 7;104(6):648-52. doi: 10.1161/hc3101.093866.