Comparison of bivalirudin versus heparin during percutaneous coronary intervention (the Randomized Evaluation of PCI Linking Angiomax to Reduced Clinical Events [REPLACE]-1 trial)
To assess the efficacy of the direct thrombin inhibitor bivalirudin relative to heparin during contemporary coronary intervention, 1,056 patients who underwent elective or urgent revascularization were randomized in a large-scale pilot study to receive heparin (70 U/kg initial bolus) or bivalirudin...
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| Published in | The American journal of cardiology Vol. 93; no. 9; pp. 1092 - 1096 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
New York, NY
Elsevier Inc
01.05.2004
Elsevier Elsevier Limited |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0002-9149 1879-1913 |
| DOI | 10.1016/j.amjcard.2004.01.033 |
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| Abstract | To assess the efficacy of the direct thrombin inhibitor bivalirudin relative to heparin during contemporary coronary intervention, 1,056 patients who underwent elective or urgent revascularization were randomized in a large-scale pilot study to receive heparin (70 U/kg initial bolus) or bivalirudin (0.75 mg/kg bolus, 1.75 mg/kg/hour infusion during the procedure). All patients received aspirin; pretreatment with clopidogrel was encouraged, and glycoprotein (GP) IIb/IIIa blockade was at the physician's discretion. Stents were placed in 85% of patients; 72% received a GP IIb/IIIa inhibitor, and 56% were pretreated with clopidogrel. Activated clotting times were higher among patients randomized to bivalirudin than among those given heparin before device activation (median 359 vs 293 seconds, p <0.001). The composite efficacy end point of death, myocardial infarction, or repeat revascularization before hospital discharge or within 48 hours occurred in 5.6% and 6.9% of patients in the bivalirudin and heparin groups, respectively (p = 0.40). Major bleeding occurred in 2.1% versus 2.7% of patients randomized to bivalirudin or heparin, respectively (p = 0.52). This trial represents the largest prospective dataset of bivalirudin administered concomitantly with planned GP IIb/IIIa blockade and provides evidence of the safety and efficacy of this combined antithrombotic approach. |
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| AbstractList | To assess the efficacy of the direct thrombin inhibitor bivalirudin relative to heparin during contemporary coronary intervention, 1,056 patients who underwent elective or urgent revascularization were randomized in a large-scale pilot study to receive heparin (70 U/kg initial bolus) or bivalirudin (0.75 mg/kg bolus, 1.75 mg/kg/hour infusion during the procedure). All patients received aspirin; pretreatment with clopidogrel was encouraged, and glycoprotein (GP) IIb/IIIa blockade was at the physician's discretion. Stents were placed in 85% of patients; 72% received a GP IIb/IIIa inhibitor, and 56% were pretreated with clopidogrel. Activated clotting times were higher among patients randomized to bivalirudin than among those given heparin before device activation (median 359 vs 293 seconds, p <0.001). The composite efficacy end point of death, myocardial infarction, or repeat revascularization before hospital discharge or within 48 hours occurred in 5.6% and 6.9% of patients in the bivalirudin and heparin groups, respectively (p = 0.40). Major bleeding occurred in 2.1% versus 2.7% of patients randomized to bivalirudin or heparin, respectively (p = 0.52). This trial represents the largest prospective dataset of bivalirudin administered concomitantly with planned GP IIb/IIIa blockade and provides evidence of the safety and efficacy of this combined antithrombotic approach. To assess the efficacy of the direct thrombin inhibitor bivalirudin relative to heparin during contemporary coronary intervention, 1,056 patients who underwent elective or urgent revascularization were randomized in a large-scale pilot study to receive heparin (70 U/kg initial bolus) or bivalirudin (0.75 mg/kg bolus, 1.75 mg/kg/hour infusion during the procedure). All patients received aspirin; pretreatment with clopidogrel was encouraged, and glycoprotein (GP) IIb/IIIa blockade was at the physician's discretion. Stents were placed in 85% of patients; 72% received a GP IIb/IIIa inhibitor, and 56% were pretreated with clopidogrel. Activated clotting times were higher among patients randomized to bivalirudin than among those given heparin before device activation (median 359 vs 293 seconds, p less than 0.001). The composite efficacy end point of death, myocardial infarction, or repeat revascularization before hospital discharge or within 48 hours occurred in 5.6% and 6.9% of patients in the bivalirudin and heparin groups, respectively (p = 0.40). Major bleeding occurred in 2.1% versus 2.7% of patients randomized to bivalirudin or heparin, respectively (p = 0.52). This trial represents the largest prospective dataset of bivalirudin administered concomitantly with planned GP IIb/IIIa blockade and provides evidence of the safety and efficacy of this combined antithrombotic approach. [PUBLICATION ABSTRACT] To assess the efficacy of the direct thrombin inhibitor bivalirudin relative to heparin during contemporary coronary intervention, 1,056 patients who underwent elective or urgent revascularization were randomized in a large-scale pilot study to receive heparin (70 U/kg initial bolus) or bivalirudin (0.75 mg/kg bolus, 1.75 mg/kg/hour infusion during the procedure). All patients received aspirin; pretreatment with clopidogrel was encouraged, and glycoprotein (GP) IIb/IIIa blockade was at the physician's discretion. Stents were placed in 85% of patients; 72% received a GP IIb/IIIa inhibitor, and 56% were pretreated with clopidogrel. Activated clotting times were higher among patients randomized to bivalirudin than among those given heparin before device activation (median 359 vs 293 seconds, p <0.001). The composite efficacy end point of death, myocardial infarction, or repeat revascularization before hospital discharge or within 48 hours occurred in 5.6% and 6.9% of patients in the bivalirudin and heparin groups, respectively (p = 0.40). Major bleeding occurred in 2.1% versus 2.7% of patients randomized to bivalirudin or heparin, respectively (p = 0.52). This trial represents the largest prospective dataset of bivalirudin administered concomitantly with planned GP IIb/IIIa blockade and provides evidence of the safety and efficacy of this combined antithrombotic approach.To assess the efficacy of the direct thrombin inhibitor bivalirudin relative to heparin during contemporary coronary intervention, 1,056 patients who underwent elective or urgent revascularization were randomized in a large-scale pilot study to receive heparin (70 U/kg initial bolus) or bivalirudin (0.75 mg/kg bolus, 1.75 mg/kg/hour infusion during the procedure). All patients received aspirin; pretreatment with clopidogrel was encouraged, and glycoprotein (GP) IIb/IIIa blockade was at the physician's discretion. Stents were placed in 85% of patients; 72% received a GP IIb/IIIa inhibitor, and 56% were pretreated with clopidogrel. Activated clotting times were higher among patients randomized to bivalirudin than among those given heparin before device activation (median 359 vs 293 seconds, p <0.001). The composite efficacy end point of death, myocardial infarction, or repeat revascularization before hospital discharge or within 48 hours occurred in 5.6% and 6.9% of patients in the bivalirudin and heparin groups, respectively (p = 0.40). Major bleeding occurred in 2.1% versus 2.7% of patients randomized to bivalirudin or heparin, respectively (p = 0.52). This trial represents the largest prospective dataset of bivalirudin administered concomitantly with planned GP IIb/IIIa blockade and provides evidence of the safety and efficacy of this combined antithrombotic approach. |
| Author | Mehta, Sameer Tift-Mann, J Kereiakes, Dean J Lincoff, A.Michael Parker, H.Graham Tannenbaum, Mark A Kleiman, Neal S Topol, Eric J Feit, Frederick Chew, Derek P Bachinsky, William B Jackman, J.Daniel Harrington, Robert A Sarembock, Ian J Maierson, Elizabeth S Niederman, Alan L Bittl, John A |
| Author_xml | – sequence: 1 givenname: A.Michael surname: Lincoff fullname: Lincoff, A.Michael email: lincofa@ccf.org organization: Cleveland Clinic Foundation, Cleveland, Ohio, USA – sequence: 2 givenname: John A surname: Bittl fullname: Bittl, John A organization: Ocala Heart Institute, Munroe Regional Medical Center, Ocala, Florida, USA – sequence: 3 givenname: Neal S surname: Kleiman fullname: Kleiman, Neal S organization: Baylor College of Medicine and Methodist Hospital, Houston, Texas, USA – sequence: 4 givenname: Ian J surname: Sarembock fullname: Sarembock, Ian J organization: University of Virginia Health System, Charlottesville, Virginia, USA – sequence: 5 givenname: J.Daniel surname: Jackman fullname: Jackman, J.Daniel organization: Tyler Cardiovascular Consultants/Trinity Mother Frances Hospital, Tyler, Texas, USA – sequence: 6 givenname: Sameer surname: Mehta fullname: Mehta, Sameer organization: Cedars Medical Center, Miami, Florida, USA – sequence: 7 givenname: Mark A surname: Tannenbaum fullname: Tannenbaum, Mark A organization: Iowa Heart Center, Des Moines, Iowa, USA – sequence: 8 givenname: Alan L surname: Niederman fullname: Niederman, Alan L organization: Greater Fort Lauderdale Heart Group Research, Fort Lauderdale, Florida, USA – sequence: 9 givenname: William B surname: Bachinsky fullname: Bachinsky, William B organization: Pinnacle Health at Harrisburgh Hospital, Harrisburgh, Pennsylvania, USA – sequence: 10 givenname: J surname: Tift-Mann fullname: Tift-Mann, J organization: Wake Heart Center, Raleigh, North Carolina, USA – sequence: 11 givenname: H.Graham surname: Parker fullname: Parker, H.Graham organization: Carolina Cardiology Consultants, Greenville, South Carolina, USA – sequence: 12 givenname: Dean J surname: Kereiakes fullname: Kereiakes, Dean J organization: The Lindner Center, Ohio Heart Health Center, Cincinnati, Ohio, USA – sequence: 13 givenname: Robert A surname: Harrington fullname: Harrington, Robert A organization: Duke Clinical Research Institute, Durham, North Carolina, USA – sequence: 14 givenname: Frederick surname: Feit fullname: Feit, Frederick organization: New York University School of Medicine, New York, New York, USA – sequence: 15 givenname: Elizabeth S surname: Maierson fullname: Maierson, Elizabeth S organization: Cleveland Clinic Foundation, Cleveland, Ohio, USA – sequence: 16 givenname: Derek P surname: Chew fullname: Chew, Derek P organization: Flinders Medical Centre, Bedford Park, SA, Australia – sequence: 17 givenname: Eric J surname: Topol fullname: Topol, Eric J organization: Cleveland Clinic Foundation, Cleveland, Ohio, USA |
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| Keywords | Evaluation Randomization Angioplasty Instrumentation therapy Clinical trial Anticoagulant Bivalirudin Circulatory system Heparin Cardiology Phlebology Comparative study |
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| Title | Comparison of bivalirudin versus heparin during percutaneous coronary intervention (the Randomized Evaluation of PCI Linking Angiomax to Reduced Clinical Events [REPLACE]-1 trial) |
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