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Michael A Lincoff - One of the best experts on this subject based on the ideXlab platform.
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influence of timing of clopidogrel treatment on the efficacy and safety of Bivalirudin in patients with non st segment elevation acute coronary syndromes undergoing percutaneous coronary intervention an analysis of the acuity acute catheterization an
Jacc-cardiovascular Interventions, 2008Co-Authors: Michael A Lincoff, Frederick Feit, Derek P Chew, Charles V Pollack, Michel E Bertrand, James H Ware, Steven R Steinhubl, Steven V Manoukian, Magnus E Ohman, Walter DesmetAbstract:Objectives This study sought to determine if the efficacy of Bivalirudin alone versus heparin plus a glycoprotein (GP) IIb/IIIa inhibitor is dependent upon the duration of clopidogrel pre-treatment in patients undergoing percutaneous coronary intervention (PCI) in the ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) trial. Background The administration of a clopidogrel loading dose several hours before PCI reduces the risk of periprocedural thrombotic events. Methods Patients with an acute coronary syndrome were randomized to heparin plus a GP IIb/IIIa inhibitor (control), Bivalirudin plus a GP IIb/IIIa inhibitor, or Bivalirudin alone. Dose and timing of clopidogrel were left to the investigator9s discretion. Results Of 13,819 patients randomized, 7,789 underwent PCI. When clopidogrel was initiated at any time before angiography or within 30 min after PCI, randomization to Bivalirudin alone (n = 2,284) or control (n = 2,189) was associated with similar ischemic outcomes (8.2% vs. 8.3%, risk ratio: 0.98, 95% confidence interval: 0.81 to 1.20). Those patients who received clopidogrel g30 min after PCI or not at all experienced an increase in ischemic events when randomized to Bivalirudin alone (n = 290) versus control (n = 317) (14.1% vs. 8.5%, risk ratio: 1.66, 95% confidence interval: 1.05 to 2.63). Major bleeding was significantly less frequent in patients treated with Bivalirudin alone. Conclusions This post-hoc analysis suggests that in acute coronary syndrome patients, as long as clopidogrel is administered before or within 30 min of PCI treatment with Bivalirudin alone is similarly effective to heparin plus a GP IIb/IIIa inhibitor in suppressing 30-day ischemic events with significantly less bleeding. If it is anticipated that clopidogrel will be given late or not at all after PCI, Bivalirudin alone may be associated with worse ischemic outcomes. (Comparison of Angiomax Versus Heparin in Acute Coronary Syndromes; NCT00093158)
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safety and efficacy of switching from either unfractionated heparin or enoxaparin to Bivalirudin in patients with non st segment elevation acute coronary syndromes managed with an invasive strategy results from the acuity acute catheterization and ur
Journal of the American College of Cardiology, 2008Co-Authors: Harvey D White, Michael A Lincoff, Frederick Feit, Derek P Chew, James W Hoekstra, Chadwick D Miller, Charles V Pollack, Michel E Bertrand, Stuart J Pocock, James H WareAbstract:Objectives The aim of this study was to compare outcomes in patients receiving consistent unfractionated heparin (UFH)/enoxaparin (ENOX) therapy and in those switched at randomization to Bivalirudin monotherapy. Background Crossover between UFH and ENOX has been associated with increased adverse outcomes in patients with acute coronary syndromes. The ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) trial demonstrated superior net clinical outcomes with similar rates of ischemia and significantly less major bleeding with Bivalirudin monotherapy compared with UFH/ENOX plus a glycoprotein (GP) IIb/IIIa inhibitor. It is unknown if these results would be preserved in patients switched from UFH/ENOX to Bivalirudin monotherapy. Methods We compared composite ischemia, major bleeding, and net clinical outcomes at 30 days in patients receiving consistent UFH/ENOX therapy and in those switched at randomization from pre-treatment with UFH/ENOX to Bivalirudin monotherapy. We also compared outcomes in patients naive to antithrombin therapy who were randomized to UFH/ENOX or Bivalirudin monotherapy. Results Two thousand one hundred thirty-seven patients received consistent UFH/ENOX (UFH n = 1,294, ENOX n = 843), and 2,078 patients pre-treated with UFH/ENOX were switched to Bivalirudin. Patients switching to Bivalirudin had similar rates of ischemia (6.9% vs. 7.4%, p = 0.52), less major bleeding (2.8% vs. 5.8%, p Conclusions Switching from UFH/ENOX to Bivalirudin monotherapy results in comparable ischemic outcomes and an approximately 50% reduction in major bleeding compared with consistent UFH/ENOX plus a GP IIb/IIIa inhibitor. Patients naive to antithrombin therapy administered Bivalirudin monotherapy had a significant reduction in bleeding and similar rates of ischemia compared with naive patients initiated with UFH or ENOX plus a GP IIb/IIIa inhibitor.
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Bivalirudin in patients with acute coronary syndromes undergoing percutaneous coronary intervention a subgroup analysis from the acute catheterization and urgent intervention triage strategy acuity trial
The Lancet, 2007Co-Authors: Gregg W Stone, Michael A Lincoff, Frederick Feit, Harvey D White, Stuart J Pocock, James H Ware, Brent T Mclaurin, Magnus E Ohman, M E Bertrand, Antonio ColomboAbstract:Summary Background The aim of this study was to assess anticoagulation with the direct thrombin inhibitor Bivalirudin during percutaneous coronary intervention in individuals with moderate and high-risk acute coronary syndromes. Methods 13 819 individuals in the Acute Catheterization and Urgent Intervention Triage strategy (ACUITY) trial were prospectively randomly assigned to receive heparin (unfractionated or enoxaparin) plus glycoprotein IIb/IIIa inhibitors, Bivalirudin plus glycoprotein IIb/IIIa inhibitors, or Bivalirudin alone. Of these individuals, 7789 underwent percutaneous coronary intervention after angiography. The effect of the three regimens on the primary 30-day endpoints of composite ischaemia (death, myocardial infarction, or unplanned revascularisation for ischaemia), major bleeding, and net clinical outcomes (composite ischaemia or major bleeding) was assessed in this subgroup. Analyses were done by intention to treat. This trial is registered with ClinicalTrials.gov, with the number NCT00093158. Findings Of the individuals who underwent percutaneous coronary intervention, 2561 received heparin plus glycoprotein IIb/IIIa inhibitors, 2609 received Bivalirudin plus glycoprotein IIb/IIIa inhibitors, and 2619 received Bivalirudin alone. 26 (0·3%) individuals dropped out or were lost to follow-up. There was no significant difference in the proportion of individuals with composite ischaemia, major bleeding, or net clinical outcomes at 30 days between those who received Bivalirudin plus glycoprotein IIb/IIIa inhibitors and those who received heparin plus glycoprotein IIb/IIIa inhibitors (composite ischaemia: 243 [9%] patients vs 210 [8%] patients, p=0·16; major bleeding: 196 [8%] patients vs 174 [7%] patients, p=0·32; net clinical outcomes: 389 [15%] patients vs 341 [13%] patients, p=0·1). Rates of composite ischaemia were much the same in those who received Bivalirudin alone and those who received heparin plus glycoprotein IIb/IIIa inhibitors (230 [9%] patients vs 210 [8%] patients, p=0·45); however, there were significantly fewer individuals who experienced major bleeding among those who received Bivalirudin alone than among those who received heparin plus glycoprotein IIb/IIIa inhibitors (92 [4%] patients vs 174 [7%] patients, p vs 341 [13%] patients, p=0·057; 0·87, 0·75–1·00). Interpretation Substitution of unfractionated heparin or enoxaparin with Bivalirudin results in comparable clinical outcomes in patients with moderate and high-risk acute coronary syndromes treated with glycoprotein IIb/IIIa inhibitors in whom percutaneous coronary intervention is done. Anticoagulation with Bivalirudin alone suppresses adverse ischaemic events to a similar extent as does heparin plus glycoprotein IIb/IIIa inhibitors, while significantly lowering the risk of major haemorrhagic complications.
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anticoagulation with Bivalirudin for off pump coronary artery bypass grafting the results of the evolution off study
The Journal of Thoracic and Cardiovascular Surgery, 2006Co-Authors: Nicholas G Smedira, Michael A Lincoff, Andreas Koster, Bruce D Spiess, M Jurmann, Cornelius M Dyke, Devinder Bhatia, Harry L Mccarthy, Solomon AronsonAbstract:Objectives Unfractionated heparin has many shortcomings, including indirect and partial inhibition of thrombin, antibody formation, and platelet activation. Bivalirudin, a short-acting direct thrombin inhibitor, avoids these limitations and has superior outcomes during percutaneous revascularization. This trial was performed to evaluate the safety and efficacy of Bivalirudin in off-pump coronary artery bypass grafting. Methods An open-label, multicenter randomized trial compared heparin with protamine reversal to Bivalirudin in patients undergoing off-pump coronary artery bypass. The primary objective was safety as demonstrated by similar rates of procedural success defined as freedom from a composite of death, myocardial infarction, stroke, and repeat revascularization. Twenty-one institutions randomized 105 patients to receive Bivalirudin and 52 patients to receive heparin. Results The mean age was 65 years for both groups. The Bivalirudin group had more grafts: 3.0 ± 1 versus 2.5 ± 1. Procedural success rates at 30 days were identical in Bivalirudin- and heparin-treated patients (93%). Operative times, total blood loss, reoperations for bleeding, and major adverse events were not significantly different. Strokes were more frequent in the heparin group: 5.5% versus 0; P = .05. Mortality was 2% in each group. Repeat revascularization was required in 3% of Bivalirudin- and 2% of the heparin-treated patients. Conclusions For patients undergoing off-pump coronary artery bypass grafting, Bivalirudin was an effective anticoagulant, without excessive bleeding and with a safety profile similar to that of heparin. Further trials are warranted to assess whether anticoagulation with Bivalirudin improves clinical outcomes.
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comparison of Bivalirudin versus heparin during percutaneous coronary intervention the randomized evaluation of pci linking angiomax to reduced clinical events replace 1 trial
American Journal of Cardiology, 2004Co-Authors: Michael A Lincoff, Neal S Kleiman, John A. Bittl, Ian J Sarembock, Daniel J Jackman, Sameer K Mehta, Mark Tannenbaum, Alan Niederman, William Bachinsky, J TiftmannAbstract: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.
Derek P Chew - One of the best experts on this subject based on the ideXlab platform.
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Relative efficacy of Bivalirudin versus heparin monotherapy in patients with ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention: a network meta-analysis
Journal of blood medicine, 2013Co-Authors: Tim Kinnaird, Goran Medic, Gianni Casella, Francois Schiele, Upendra Kaul, Peter W Radke, Indra Eijgelshoven, Gert Bergman, Derek P ChewAbstract:In the absence of head-to-head clinical data, the objective of this study was to indirectly compare the efficacy and safety of a Bivalirudin-based anticoagulation strategy with that of heparin monotherapy in patients with ST-elevation myocardial infarction (STEMI) intended for primary percutaneous coronary intervention. A systematic literature review was performed to identify randomized controlled trials to build a network of Bivalirudin and heparin monotherapy strategies in STEMI patients using heparin, with glycoprotein IIb/IIIa inhibitor as a common reference strategy. At 30 days, the Bivalirudin-based strategy was expected to result in lower mortality rates than heparin monotherapy (odds ratio [OR], 0.55; credible limit [CrL], 0.32-0.95). This relationship was sustained at 1 year. At 30 days, the risk for stroke (OR, 0.88; CrL, 0.37-2.13), myocardial infarction (OR, 0.79; CrL, 0.40-1.55), and thrombolysis in myocardial infarction major and minor bleedings (OR, 0.66; CrL, 0.45-0.98) tended to be numerically reduced with Bivalirudin in comparison with heparin monotherapy. For patients with STEMI intended for primary percutaneous coronary intervention, Bivalirudin is associated with lower mortality rates in comparison with heparin monotherapy. This study suggests that Bivalirudin is more effective and safer than heparin monotherapy and should therefore be preferred over heparin monotherapy.
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influence of timing of clopidogrel treatment on the efficacy and safety of Bivalirudin in patients with non st segment elevation acute coronary syndromes undergoing percutaneous coronary intervention an analysis of the acuity acute catheterization an
Jacc-cardiovascular Interventions, 2008Co-Authors: Michael A Lincoff, Frederick Feit, Derek P Chew, Charles V Pollack, Michel E Bertrand, James H Ware, Steven R Steinhubl, Steven V Manoukian, Magnus E Ohman, Walter DesmetAbstract:Objectives This study sought to determine if the efficacy of Bivalirudin alone versus heparin plus a glycoprotein (GP) IIb/IIIa inhibitor is dependent upon the duration of clopidogrel pre-treatment in patients undergoing percutaneous coronary intervention (PCI) in the ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) trial. Background The administration of a clopidogrel loading dose several hours before PCI reduces the risk of periprocedural thrombotic events. Methods Patients with an acute coronary syndrome were randomized to heparin plus a GP IIb/IIIa inhibitor (control), Bivalirudin plus a GP IIb/IIIa inhibitor, or Bivalirudin alone. Dose and timing of clopidogrel were left to the investigator9s discretion. Results Of 13,819 patients randomized, 7,789 underwent PCI. When clopidogrel was initiated at any time before angiography or within 30 min after PCI, randomization to Bivalirudin alone (n = 2,284) or control (n = 2,189) was associated with similar ischemic outcomes (8.2% vs. 8.3%, risk ratio: 0.98, 95% confidence interval: 0.81 to 1.20). Those patients who received clopidogrel g30 min after PCI or not at all experienced an increase in ischemic events when randomized to Bivalirudin alone (n = 290) versus control (n = 317) (14.1% vs. 8.5%, risk ratio: 1.66, 95% confidence interval: 1.05 to 2.63). Major bleeding was significantly less frequent in patients treated with Bivalirudin alone. Conclusions This post-hoc analysis suggests that in acute coronary syndrome patients, as long as clopidogrel is administered before or within 30 min of PCI treatment with Bivalirudin alone is similarly effective to heparin plus a GP IIb/IIIa inhibitor in suppressing 30-day ischemic events with significantly less bleeding. If it is anticipated that clopidogrel will be given late or not at all after PCI, Bivalirudin alone may be associated with worse ischemic outcomes. (Comparison of Angiomax Versus Heparin in Acute Coronary Syndromes; NCT00093158)
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safety and efficacy of switching from either unfractionated heparin or enoxaparin to Bivalirudin in patients with non st segment elevation acute coronary syndromes managed with an invasive strategy results from the acuity acute catheterization and ur
Journal of the American College of Cardiology, 2008Co-Authors: Harvey D White, Michael A Lincoff, Frederick Feit, Derek P Chew, James W Hoekstra, Chadwick D Miller, Charles V Pollack, Michel E Bertrand, Stuart J Pocock, James H WareAbstract:Objectives The aim of this study was to compare outcomes in patients receiving consistent unfractionated heparin (UFH)/enoxaparin (ENOX) therapy and in those switched at randomization to Bivalirudin monotherapy. Background Crossover between UFH and ENOX has been associated with increased adverse outcomes in patients with acute coronary syndromes. The ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) trial demonstrated superior net clinical outcomes with similar rates of ischemia and significantly less major bleeding with Bivalirudin monotherapy compared with UFH/ENOX plus a glycoprotein (GP) IIb/IIIa inhibitor. It is unknown if these results would be preserved in patients switched from UFH/ENOX to Bivalirudin monotherapy. Methods We compared composite ischemia, major bleeding, and net clinical outcomes at 30 days in patients receiving consistent UFH/ENOX therapy and in those switched at randomization from pre-treatment with UFH/ENOX to Bivalirudin monotherapy. We also compared outcomes in patients naive to antithrombin therapy who were randomized to UFH/ENOX or Bivalirudin monotherapy. Results Two thousand one hundred thirty-seven patients received consistent UFH/ENOX (UFH n = 1,294, ENOX n = 843), and 2,078 patients pre-treated with UFH/ENOX were switched to Bivalirudin. Patients switching to Bivalirudin had similar rates of ischemia (6.9% vs. 7.4%, p = 0.52), less major bleeding (2.8% vs. 5.8%, p Conclusions Switching from UFH/ENOX to Bivalirudin monotherapy results in comparable ischemic outcomes and an approximately 50% reduction in major bleeding compared with consistent UFH/ENOX plus a GP IIb/IIIa inhibitor. Patients naive to antithrombin therapy administered Bivalirudin monotherapy had a significant reduction in bleeding and similar rates of ischemia compared with naive patients initiated with UFH or ENOX plus a GP IIb/IIIa inhibitor.
Frederick Feit - One of the best experts on this subject based on the ideXlab platform.
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influence of timing of clopidogrel treatment on the efficacy and safety of Bivalirudin in patients with non st segment elevation acute coronary syndromes undergoing percutaneous coronary intervention an analysis of the acuity acute catheterization an
Jacc-cardiovascular Interventions, 2008Co-Authors: Michael A Lincoff, Frederick Feit, Derek P Chew, Charles V Pollack, Michel E Bertrand, James H Ware, Steven R Steinhubl, Steven V Manoukian, Magnus E Ohman, Walter DesmetAbstract:Objectives This study sought to determine if the efficacy of Bivalirudin alone versus heparin plus a glycoprotein (GP) IIb/IIIa inhibitor is dependent upon the duration of clopidogrel pre-treatment in patients undergoing percutaneous coronary intervention (PCI) in the ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) trial. Background The administration of a clopidogrel loading dose several hours before PCI reduces the risk of periprocedural thrombotic events. Methods Patients with an acute coronary syndrome were randomized to heparin plus a GP IIb/IIIa inhibitor (control), Bivalirudin plus a GP IIb/IIIa inhibitor, or Bivalirudin alone. Dose and timing of clopidogrel were left to the investigator9s discretion. Results Of 13,819 patients randomized, 7,789 underwent PCI. When clopidogrel was initiated at any time before angiography or within 30 min after PCI, randomization to Bivalirudin alone (n = 2,284) or control (n = 2,189) was associated with similar ischemic outcomes (8.2% vs. 8.3%, risk ratio: 0.98, 95% confidence interval: 0.81 to 1.20). Those patients who received clopidogrel g30 min after PCI or not at all experienced an increase in ischemic events when randomized to Bivalirudin alone (n = 290) versus control (n = 317) (14.1% vs. 8.5%, risk ratio: 1.66, 95% confidence interval: 1.05 to 2.63). Major bleeding was significantly less frequent in patients treated with Bivalirudin alone. Conclusions This post-hoc analysis suggests that in acute coronary syndrome patients, as long as clopidogrel is administered before or within 30 min of PCI treatment with Bivalirudin alone is similarly effective to heparin plus a GP IIb/IIIa inhibitor in suppressing 30-day ischemic events with significantly less bleeding. If it is anticipated that clopidogrel will be given late or not at all after PCI, Bivalirudin alone may be associated with worse ischemic outcomes. (Comparison of Angiomax Versus Heparin in Acute Coronary Syndromes; NCT00093158)
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safety and efficacy of switching from either unfractionated heparin or enoxaparin to Bivalirudin in patients with non st segment elevation acute coronary syndromes managed with an invasive strategy results from the acuity acute catheterization and ur
Journal of the American College of Cardiology, 2008Co-Authors: Harvey D White, Michael A Lincoff, Frederick Feit, Derek P Chew, James W Hoekstra, Chadwick D Miller, Charles V Pollack, Michel E Bertrand, Stuart J Pocock, James H WareAbstract:Objectives The aim of this study was to compare outcomes in patients receiving consistent unfractionated heparin (UFH)/enoxaparin (ENOX) therapy and in those switched at randomization to Bivalirudin monotherapy. Background Crossover between UFH and ENOX has been associated with increased adverse outcomes in patients with acute coronary syndromes. The ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) trial demonstrated superior net clinical outcomes with similar rates of ischemia and significantly less major bleeding with Bivalirudin monotherapy compared with UFH/ENOX plus a glycoprotein (GP) IIb/IIIa inhibitor. It is unknown if these results would be preserved in patients switched from UFH/ENOX to Bivalirudin monotherapy. Methods We compared composite ischemia, major bleeding, and net clinical outcomes at 30 days in patients receiving consistent UFH/ENOX therapy and in those switched at randomization from pre-treatment with UFH/ENOX to Bivalirudin monotherapy. We also compared outcomes in patients naive to antithrombin therapy who were randomized to UFH/ENOX or Bivalirudin monotherapy. Results Two thousand one hundred thirty-seven patients received consistent UFH/ENOX (UFH n = 1,294, ENOX n = 843), and 2,078 patients pre-treated with UFH/ENOX were switched to Bivalirudin. Patients switching to Bivalirudin had similar rates of ischemia (6.9% vs. 7.4%, p = 0.52), less major bleeding (2.8% vs. 5.8%, p Conclusions Switching from UFH/ENOX to Bivalirudin monotherapy results in comparable ischemic outcomes and an approximately 50% reduction in major bleeding compared with consistent UFH/ENOX plus a GP IIb/IIIa inhibitor. Patients naive to antithrombin therapy administered Bivalirudin monotherapy had a significant reduction in bleeding and similar rates of ischemia compared with naive patients initiated with UFH or ENOX plus a GP IIb/IIIa inhibitor.
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Bivalirudin in patients with acute coronary syndromes undergoing percutaneous coronary intervention a subgroup analysis from the acute catheterization and urgent intervention triage strategy acuity trial
The Lancet, 2007Co-Authors: Gregg W Stone, Michael A Lincoff, Frederick Feit, Harvey D White, Stuart J Pocock, James H Ware, Brent T Mclaurin, Magnus E Ohman, M E Bertrand, Antonio ColomboAbstract:Summary Background The aim of this study was to assess anticoagulation with the direct thrombin inhibitor Bivalirudin during percutaneous coronary intervention in individuals with moderate and high-risk acute coronary syndromes. Methods 13 819 individuals in the Acute Catheterization and Urgent Intervention Triage strategy (ACUITY) trial were prospectively randomly assigned to receive heparin (unfractionated or enoxaparin) plus glycoprotein IIb/IIIa inhibitors, Bivalirudin plus glycoprotein IIb/IIIa inhibitors, or Bivalirudin alone. Of these individuals, 7789 underwent percutaneous coronary intervention after angiography. The effect of the three regimens on the primary 30-day endpoints of composite ischaemia (death, myocardial infarction, or unplanned revascularisation for ischaemia), major bleeding, and net clinical outcomes (composite ischaemia or major bleeding) was assessed in this subgroup. Analyses were done by intention to treat. This trial is registered with ClinicalTrials.gov, with the number NCT00093158. Findings Of the individuals who underwent percutaneous coronary intervention, 2561 received heparin plus glycoprotein IIb/IIIa inhibitors, 2609 received Bivalirudin plus glycoprotein IIb/IIIa inhibitors, and 2619 received Bivalirudin alone. 26 (0·3%) individuals dropped out or were lost to follow-up. There was no significant difference in the proportion of individuals with composite ischaemia, major bleeding, or net clinical outcomes at 30 days between those who received Bivalirudin plus glycoprotein IIb/IIIa inhibitors and those who received heparin plus glycoprotein IIb/IIIa inhibitors (composite ischaemia: 243 [9%] patients vs 210 [8%] patients, p=0·16; major bleeding: 196 [8%] patients vs 174 [7%] patients, p=0·32; net clinical outcomes: 389 [15%] patients vs 341 [13%] patients, p=0·1). Rates of composite ischaemia were much the same in those who received Bivalirudin alone and those who received heparin plus glycoprotein IIb/IIIa inhibitors (230 [9%] patients vs 210 [8%] patients, p=0·45); however, there were significantly fewer individuals who experienced major bleeding among those who received Bivalirudin alone than among those who received heparin plus glycoprotein IIb/IIIa inhibitors (92 [4%] patients vs 174 [7%] patients, p vs 341 [13%] patients, p=0·057; 0·87, 0·75–1·00). Interpretation Substitution of unfractionated heparin or enoxaparin with Bivalirudin results in comparable clinical outcomes in patients with moderate and high-risk acute coronary syndromes treated with glycoprotein IIb/IIIa inhibitors in whom percutaneous coronary intervention is done. Anticoagulation with Bivalirudin alone suppresses adverse ischaemic events to a similar extent as does heparin plus glycoprotein IIb/IIIa inhibitors, while significantly lowering the risk of major haemorrhagic complications.
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Bivalirudin versus heparin during coronary angioplasty for unstable or postinfarction angina final report reanalysis of the Bivalirudin angioplasty study
American Heart Journal, 2001Co-Authors: John A. Bittl, Bernard R Chaitman, Frederick Feit, William Kimball, Eric J TopolAbstract:Abstract Background This study was a reanalysis of the Bivalirudin Angioplasty Study, which compared Bivalirudin with high-dose heparin during coronary angioplasty for unstable angina. Methods Differences in rates of death, myocardial infarction, or repeat revascularization were compared at 7, 90, and 180 days after angioplasty with intention-to-treat analysis. Results The combined end point occurred in 135 of 2161 patients (6.2%) in the Bivalirudin group and in 169 of 2151 patients (7.9%) in the heparin group at 7 days ( P = .039). Differences persisted between the groups at 90 days ( P = .012) and 180 days ( P = .153). Bleeding occurred in 76 patients (3.5%) in the Bivalirudin group versus 199 (9.3%) in the heparin group ( P Conclusions This analysis supports the hypothesis that Bivalirudin reduces ischemic complications and bleeding after angioplasty. Further trials are needed to evaluate Bivalirudin versus heparin in conjunction with platelet-glycoprotein IIb/IIIa inhibitors and for coronary stenting. (Am Heart J 2001;142:952-9.)
Harvey D White - One of the best experts on this subject based on the ideXlab platform.
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safety and efficacy of switching from either unfractionated heparin or enoxaparin to Bivalirudin in patients with non st segment elevation acute coronary syndromes managed with an invasive strategy results from the acuity acute catheterization and ur
Journal of the American College of Cardiology, 2008Co-Authors: Harvey D White, Michael A Lincoff, Frederick Feit, Derek P Chew, James W Hoekstra, Chadwick D Miller, Charles V Pollack, Michel E Bertrand, Stuart J Pocock, James H WareAbstract:Objectives The aim of this study was to compare outcomes in patients receiving consistent unfractionated heparin (UFH)/enoxaparin (ENOX) therapy and in those switched at randomization to Bivalirudin monotherapy. Background Crossover between UFH and ENOX has been associated with increased adverse outcomes in patients with acute coronary syndromes. The ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) trial demonstrated superior net clinical outcomes with similar rates of ischemia and significantly less major bleeding with Bivalirudin monotherapy compared with UFH/ENOX plus a glycoprotein (GP) IIb/IIIa inhibitor. It is unknown if these results would be preserved in patients switched from UFH/ENOX to Bivalirudin monotherapy. Methods We compared composite ischemia, major bleeding, and net clinical outcomes at 30 days in patients receiving consistent UFH/ENOX therapy and in those switched at randomization from pre-treatment with UFH/ENOX to Bivalirudin monotherapy. We also compared outcomes in patients naive to antithrombin therapy who were randomized to UFH/ENOX or Bivalirudin monotherapy. Results Two thousand one hundred thirty-seven patients received consistent UFH/ENOX (UFH n = 1,294, ENOX n = 843), and 2,078 patients pre-treated with UFH/ENOX were switched to Bivalirudin. Patients switching to Bivalirudin had similar rates of ischemia (6.9% vs. 7.4%, p = 0.52), less major bleeding (2.8% vs. 5.8%, p Conclusions Switching from UFH/ENOX to Bivalirudin monotherapy results in comparable ischemic outcomes and an approximately 50% reduction in major bleeding compared with consistent UFH/ENOX plus a GP IIb/IIIa inhibitor. Patients naive to antithrombin therapy administered Bivalirudin monotherapy had a significant reduction in bleeding and similar rates of ischemia compared with naive patients initiated with UFH or ENOX plus a GP IIb/IIIa inhibitor.
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Bivalirudin in patients with acute coronary syndromes undergoing percutaneous coronary intervention a subgroup analysis from the acute catheterization and urgent intervention triage strategy acuity trial
The Lancet, 2007Co-Authors: Gregg W Stone, Michael A Lincoff, Frederick Feit, Harvey D White, Stuart J Pocock, James H Ware, Brent T Mclaurin, Magnus E Ohman, M E Bertrand, Antonio ColomboAbstract:Summary Background The aim of this study was to assess anticoagulation with the direct thrombin inhibitor Bivalirudin during percutaneous coronary intervention in individuals with moderate and high-risk acute coronary syndromes. Methods 13 819 individuals in the Acute Catheterization and Urgent Intervention Triage strategy (ACUITY) trial were prospectively randomly assigned to receive heparin (unfractionated or enoxaparin) plus glycoprotein IIb/IIIa inhibitors, Bivalirudin plus glycoprotein IIb/IIIa inhibitors, or Bivalirudin alone. Of these individuals, 7789 underwent percutaneous coronary intervention after angiography. The effect of the three regimens on the primary 30-day endpoints of composite ischaemia (death, myocardial infarction, or unplanned revascularisation for ischaemia), major bleeding, and net clinical outcomes (composite ischaemia or major bleeding) was assessed in this subgroup. Analyses were done by intention to treat. This trial is registered with ClinicalTrials.gov, with the number NCT00093158. Findings Of the individuals who underwent percutaneous coronary intervention, 2561 received heparin plus glycoprotein IIb/IIIa inhibitors, 2609 received Bivalirudin plus glycoprotein IIb/IIIa inhibitors, and 2619 received Bivalirudin alone. 26 (0·3%) individuals dropped out or were lost to follow-up. There was no significant difference in the proportion of individuals with composite ischaemia, major bleeding, or net clinical outcomes at 30 days between those who received Bivalirudin plus glycoprotein IIb/IIIa inhibitors and those who received heparin plus glycoprotein IIb/IIIa inhibitors (composite ischaemia: 243 [9%] patients vs 210 [8%] patients, p=0·16; major bleeding: 196 [8%] patients vs 174 [7%] patients, p=0·32; net clinical outcomes: 389 [15%] patients vs 341 [13%] patients, p=0·1). Rates of composite ischaemia were much the same in those who received Bivalirudin alone and those who received heparin plus glycoprotein IIb/IIIa inhibitors (230 [9%] patients vs 210 [8%] patients, p=0·45); however, there were significantly fewer individuals who experienced major bleeding among those who received Bivalirudin alone than among those who received heparin plus glycoprotein IIb/IIIa inhibitors (92 [4%] patients vs 174 [7%] patients, p vs 341 [13%] patients, p=0·057; 0·87, 0·75–1·00). Interpretation Substitution of unfractionated heparin or enoxaparin with Bivalirudin results in comparable clinical outcomes in patients with moderate and high-risk acute coronary syndromes treated with glycoprotein IIb/IIIa inhibitors in whom percutaneous coronary intervention is done. Anticoagulation with Bivalirudin alone suppresses adverse ischaemic events to a similar extent as does heparin plus glycoprotein IIb/IIIa inhibitors, while significantly lowering the risk of major haemorrhagic complications.
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Bivalirudin versus heparin and protamine in off pump coronary artery bypass surgery
The Annals of Thoracic Surgery, 2004Co-Authors: Alan Merry, Peter J Raudkivi, N G Middleton, John M Mcdougall, Parma Nand, Brigid P Mills, Bruce Webber, Chris Frampton, Harvey D WhiteAbstract:Abstract Background Bivalirudin is a short-acting direct thrombin inhibitor, with advantages over unfractionated heparin for anticoagulation in cardiac surgery. We hypothesized that Bivalirudin is not associated with a clinically important increase in blood loss compared with heparin with protamine reversal in patients undergoing off pump coronary artery bypass (OPCAB) surgery. We also assessed flow with angiography at 3 months using a modified Thombolysis in Myocardial Infarction (TIMI) grade in the grafted coronary arteries. Methods One hundred patients were randomly assigned to receive Bivalirudin (0.75 mg/kg bolus, 1.75 mg/kg/h infusion) or heparin (150 to 300 U/kg bolus) with protamine reversal. Results A median of 3 (range, 1 to 5) grafts were inserted per patient. Blood loss for the 12 hours after study drug initiation in the Bivalirudin group (median, 793 mL; interquartile range, 532 to 1,214 mL; range, 320 to 4,909 mL; n=50) was not significantly greater than in the heparin group (median, 805 mL; interquartile range, 517 to 1,117 mL; range, 201 to 2,567 mL; n=50; p = 0.165). Median graft flow was 3.0 in the Bivalirudin group (n = 40) and 2.67 in the heparin group (n = 39; p = 0.047). The Bivalirudin group had more patients with grade 3 (ie, full) flow in at least 1 graft (100% versus 90%; p = 0.04), a trend toward more patients with grade 3 flow in all grafts (60% versus 38%; p = 0.06), and more grafts with grade 3 flow (82% versus 67%; p = 0.03). Conclusions Anticoagulation for OPCAB surgery with Bivalirudin was feasible without a clinically important increase in perioperative blood loss. Graft flow was better in the Bivalirudin patients; the impact of this on clinical outcomes requires a larger study.
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Clinical Outcomes of Bivalirudin for Ischemic Heart Disease
Circulation, 1999Co-Authors: David F. Kong, Eric J Topol, John A. Bittl, Harvey D White, Pierre Théroux, Vic Hasselblad, Robert M. CaliffAbstract:Background—Current treatment strategies for percutaneous coronary revascularization and acute coronary syndromes incorporate thrombin inhibition with either unfractionated or fractionated heparin. The peptide Bivalirudin (Hirulog) is a direct thrombin inhibitor whose pharmacological properties differ from those of heparin. We conducted a systematic overview (meta-analysis) to assess the effect of Bivalirudin on 4 end points: death, myocardial infarction, major hemorrhage, and the composite of death or infarction. Methods and Results—Six trials (5674 patients) represent the randomized, controlled Bivalirudin experience, including 4603 patients undergoing elective percutaneous coronary revascularization and 1071 patients with acute coronary syndromes. ORs for the 4 clinical end points were calculated for each trial. Four trials (4973 patients) that compared Bivalirudin with heparin were combined with the use of a random-effects model. In these trials, Bivalirudin was associated with a significant reduction ...
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influence of timing of clopidogrel treatment on the efficacy and safety of Bivalirudin in patients with non st segment elevation acute coronary syndromes undergoing percutaneous coronary intervention an analysis of the acuity acute catheterization an
Jacc-cardiovascular Interventions, 2008Co-Authors: Michael A Lincoff, Frederick Feit, Derek P Chew, Charles V Pollack, Michel E Bertrand, James H Ware, Steven R Steinhubl, Steven V Manoukian, Magnus E Ohman, Walter DesmetAbstract:Objectives This study sought to determine if the efficacy of Bivalirudin alone versus heparin plus a glycoprotein (GP) IIb/IIIa inhibitor is dependent upon the duration of clopidogrel pre-treatment in patients undergoing percutaneous coronary intervention (PCI) in the ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) trial. Background The administration of a clopidogrel loading dose several hours before PCI reduces the risk of periprocedural thrombotic events. Methods Patients with an acute coronary syndrome were randomized to heparin plus a GP IIb/IIIa inhibitor (control), Bivalirudin plus a GP IIb/IIIa inhibitor, or Bivalirudin alone. Dose and timing of clopidogrel were left to the investigator9s discretion. Results Of 13,819 patients randomized, 7,789 underwent PCI. When clopidogrel was initiated at any time before angiography or within 30 min after PCI, randomization to Bivalirudin alone (n = 2,284) or control (n = 2,189) was associated with similar ischemic outcomes (8.2% vs. 8.3%, risk ratio: 0.98, 95% confidence interval: 0.81 to 1.20). Those patients who received clopidogrel g30 min after PCI or not at all experienced an increase in ischemic events when randomized to Bivalirudin alone (n = 290) versus control (n = 317) (14.1% vs. 8.5%, risk ratio: 1.66, 95% confidence interval: 1.05 to 2.63). Major bleeding was significantly less frequent in patients treated with Bivalirudin alone. Conclusions This post-hoc analysis suggests that in acute coronary syndrome patients, as long as clopidogrel is administered before or within 30 min of PCI treatment with Bivalirudin alone is similarly effective to heparin plus a GP IIb/IIIa inhibitor in suppressing 30-day ischemic events with significantly less bleeding. If it is anticipated that clopidogrel will be given late or not at all after PCI, Bivalirudin alone may be associated with worse ischemic outcomes. (Comparison of Angiomax Versus Heparin in Acute Coronary Syndromes; NCT00093158)
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safety and efficacy of switching from either unfractionated heparin or enoxaparin to Bivalirudin in patients with non st segment elevation acute coronary syndromes managed with an invasive strategy results from the acuity acute catheterization and ur
Journal of the American College of Cardiology, 2008Co-Authors: Harvey D White, Michael A Lincoff, Frederick Feit, Derek P Chew, James W Hoekstra, Chadwick D Miller, Charles V Pollack, Michel E Bertrand, Stuart J Pocock, James H WareAbstract:Objectives The aim of this study was to compare outcomes in patients receiving consistent unfractionated heparin (UFH)/enoxaparin (ENOX) therapy and in those switched at randomization to Bivalirudin monotherapy. Background Crossover between UFH and ENOX has been associated with increased adverse outcomes in patients with acute coronary syndromes. The ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) trial demonstrated superior net clinical outcomes with similar rates of ischemia and significantly less major bleeding with Bivalirudin monotherapy compared with UFH/ENOX plus a glycoprotein (GP) IIb/IIIa inhibitor. It is unknown if these results would be preserved in patients switched from UFH/ENOX to Bivalirudin monotherapy. Methods We compared composite ischemia, major bleeding, and net clinical outcomes at 30 days in patients receiving consistent UFH/ENOX therapy and in those switched at randomization from pre-treatment with UFH/ENOX to Bivalirudin monotherapy. We also compared outcomes in patients naive to antithrombin therapy who were randomized to UFH/ENOX or Bivalirudin monotherapy. Results Two thousand one hundred thirty-seven patients received consistent UFH/ENOX (UFH n = 1,294, ENOX n = 843), and 2,078 patients pre-treated with UFH/ENOX were switched to Bivalirudin. Patients switching to Bivalirudin had similar rates of ischemia (6.9% vs. 7.4%, p = 0.52), less major bleeding (2.8% vs. 5.8%, p Conclusions Switching from UFH/ENOX to Bivalirudin monotherapy results in comparable ischemic outcomes and an approximately 50% reduction in major bleeding compared with consistent UFH/ENOX plus a GP IIb/IIIa inhibitor. Patients naive to antithrombin therapy administered Bivalirudin monotherapy had a significant reduction in bleeding and similar rates of ischemia compared with naive patients initiated with UFH or ENOX plus a GP IIb/IIIa inhibitor.
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Bivalirudin in patients with acute coronary syndromes undergoing percutaneous coronary intervention a subgroup analysis from the acute catheterization and urgent intervention triage strategy acuity trial
The Lancet, 2007Co-Authors: Gregg W Stone, Michael A Lincoff, Frederick Feit, Harvey D White, Stuart J Pocock, James H Ware, Brent T Mclaurin, Magnus E Ohman, M E Bertrand, Antonio ColomboAbstract:Summary Background The aim of this study was to assess anticoagulation with the direct thrombin inhibitor Bivalirudin during percutaneous coronary intervention in individuals with moderate and high-risk acute coronary syndromes. Methods 13 819 individuals in the Acute Catheterization and Urgent Intervention Triage strategy (ACUITY) trial were prospectively randomly assigned to receive heparin (unfractionated or enoxaparin) plus glycoprotein IIb/IIIa inhibitors, Bivalirudin plus glycoprotein IIb/IIIa inhibitors, or Bivalirudin alone. Of these individuals, 7789 underwent percutaneous coronary intervention after angiography. The effect of the three regimens on the primary 30-day endpoints of composite ischaemia (death, myocardial infarction, or unplanned revascularisation for ischaemia), major bleeding, and net clinical outcomes (composite ischaemia or major bleeding) was assessed in this subgroup. Analyses were done by intention to treat. This trial is registered with ClinicalTrials.gov, with the number NCT00093158. Findings Of the individuals who underwent percutaneous coronary intervention, 2561 received heparin plus glycoprotein IIb/IIIa inhibitors, 2609 received Bivalirudin plus glycoprotein IIb/IIIa inhibitors, and 2619 received Bivalirudin alone. 26 (0·3%) individuals dropped out or were lost to follow-up. There was no significant difference in the proportion of individuals with composite ischaemia, major bleeding, or net clinical outcomes at 30 days between those who received Bivalirudin plus glycoprotein IIb/IIIa inhibitors and those who received heparin plus glycoprotein IIb/IIIa inhibitors (composite ischaemia: 243 [9%] patients vs 210 [8%] patients, p=0·16; major bleeding: 196 [8%] patients vs 174 [7%] patients, p=0·32; net clinical outcomes: 389 [15%] patients vs 341 [13%] patients, p=0·1). Rates of composite ischaemia were much the same in those who received Bivalirudin alone and those who received heparin plus glycoprotein IIb/IIIa inhibitors (230 [9%] patients vs 210 [8%] patients, p=0·45); however, there were significantly fewer individuals who experienced major bleeding among those who received Bivalirudin alone than among those who received heparin plus glycoprotein IIb/IIIa inhibitors (92 [4%] patients vs 174 [7%] patients, p vs 341 [13%] patients, p=0·057; 0·87, 0·75–1·00). Interpretation Substitution of unfractionated heparin or enoxaparin with Bivalirudin results in comparable clinical outcomes in patients with moderate and high-risk acute coronary syndromes treated with glycoprotein IIb/IIIa inhibitors in whom percutaneous coronary intervention is done. Anticoagulation with Bivalirudin alone suppresses adverse ischaemic events to a similar extent as does heparin plus glycoprotein IIb/IIIa inhibitors, while significantly lowering the risk of major haemorrhagic complications.