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Antithrombins: Direct Inhibitors (Bivalirudin)

 Contents
Pathophysiology & Mechanisms of Action
Safety
REPLACE 2 Results
Peripheral Vascular Disease
ACUITY Overall Results
ACUITY Substudy Results
HORIZONS AMI Focus Center
Other Trials of Bivalirudin in STEMI
 Pathophysiology & Mechanisms of Action

Bivalirudin: Using Movies Not Words to Show the Benefits: A series of downloadable Powerpoint slide videos presented by CM Gibson. What does binding to clot bound thrombin look like anyway?

     
     -What does it look like to be a "Direct" thrombin inhibitor, and why is that important?

      -What does it look like to inhibit "Clot bound thrombin", and why is it important?

      -What does it look like when heparin "gets distracted" and binds to heparin binding proteins while bivalirudin "stays focused" and binds to thrombin only?

      -Because heparin is non specific and binds to platelet factor 4, it triggers an antibody reaction that in turn is associated with HIT or heparin induced thrombocytopenia

      -What does it look like when heparin activates platelets and bivalirudin does not?

      -Why is Bivalirudin associated with less bleeding? See how it becomes inactivated when it falls off thrombin, unlike heparin which remains active

      -Bivalirudin With and Without Eptifibatide for Elective Stenting: A Pharmacodynamic Study of Platelet Reactivity in Relation to the Occurrence of Periprocedural Myocardial Infarction Results from the CLEAR PLATELETS-2 Study

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 Safety

Is it Safe to Switch Antithrombins at the Time of PCI?
A Review of Data by C. Michael Gibson, M.S., M.D.

      -Watch the video by clicking here

      -Is it Safe to Switch Between Antithrobins?

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 REPLACE 2 Results

Association of Bleeding and Transfusion with Mortality

      -In the Elderly by Dr. Michael A. Nelson (AHA 2006)

Bleeding among patients with CrCl > 90

      -When Treated with Eptifibatide vs Bivalirudin by Dr. Michael C. McDaniel (AHA 2006)

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 Peripheral Vascular Disease

Bivalirudin in Peripheral Vascular Disease
Bivalirudin is not currently labeled for use in peripheral arterial interventions. Shown below are registry data evaluating its use.

      -APPROVE and Registry Data in the Periphery

      -Randomized Double Blind Trial of Thrombin Receptor Antagonist (TRA) by Dr. David J. Moliterno

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 ACUITY Overall Results

ACUITY: Acute Catheterization and Urgent Intervention Triage Strategy Trial

      -Overall Trial Results by Dr. Gregg W. Stone

      -Final One-Year Results by Dr. Gregg W. Stone

ACUITY PCI

      -Trial Overview by Dr. Gregg W. Stone (TCT 2006)

      -Trial Overview by Dr. Harvey White

ACUITY Timing

      -Trial Results by Dr. Gregg W. Stone

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 ACUITY Substudy Results

Anemia

      -Impact of Anemia on One-Year Ischemic Events and Mortality Among Patients with ACS Undergoing PCI by Dr. Steven V. Manoukian (TCT 2007)

Angiographic Results

      -Angiographic Findings in ACUITY by Dr. Alexandra J. Lansky (TCT 2006)

Bleeding Results

      -Major Bleeding is Associated with Increased 30-Day Mortality and Ischemic Complications in Patients with Non-ST Elevation ACS Undergoing PCI by Dr. Steven V. Manoukian (TCT 2006)

      -Major Bleeding is Associated with Increased Short-Term Mortality and Ischemic Complications in Non-ST Elevation ACS by Dr. Steven V. Manoukian (AHA 2006)

      -Major Bleeding is Associated with Increased One-Year Mortality and Ischemic Events in Patients with ACS Undergoing PCI by Dr. Steven V. Manoukian (TCT 2007)

CABG / Thienopyridine Results

      -Implications of Preoperative Thienopyridine Use Prior to CABG by Dr. Ramin Ebrahimi (TCT 2006)

Comparison of Antithrombins Upstream

      -Optimal Upstream Antithrombin Therapy in NSTE ACS Patients Managed in the Cardiac Cath Lab: Does it Matter which Agent is Started in the ED? by Dr. Charles V. Pollack

Diabetic Results

      -Bivalirudin Monotheraphy Improves 30-day Clinical Outcomes in Diabetics with Acute Coronary Syndrome by Dr. Frederick Feit (AHA 2006)

Economic Results

      -Cost-Effectiveness in Acute Coronary Syndromes: The ACUITY Economic Study by Dr. David J. Cohen (TCT 2006)

Elderly Results

      -Outcomes in Elderly Patients Undergoing PCI Treated with Bivalirudin Monotherapy versus Glycoprotein IIb/IIIa Inhibitors with Heparin or LMWH by Dr. Karen P. Alexander (TCT 2006)

Gender and Outcomes

      -Gender Differences in Outcomes Following PCI of Patients with Non-ST Elevation ACS by Dr. Ken Mori (TCT 2006)

      -Gender Differences in Long-Term Outcomes Following PCI of Patients with Non-ST Elevation ACS by Dr. Alexandra J. Lansky (TCT 2007)

Impact of Duration of Infusion < 24 hours or > 25 hours

      -Safety and Efficacy of Bivalirudin in Patients Undergoing PCI by Dr. David Cox (TCT 2006)

      -Safety and Effectiveness of Bivalirudin in NSTE ACS by Duration of the Upstream Infusion by Dr. Charles Pollack (AHA 2006)

Long-term Outcomes of Patients with ACS and Chronic Renal Insufficiency

      -Undergoing PCI and being Treated with Bivalirudin vs. UFH/Enoxaparin plus a GP IIb/IIIa Inhibitor by Dr. Roxana Mehran (TCT 2007)

One-Year Results from the ACUITY Trial

      -Safety and Efficacy of Bivalirudin in Patients with Non-ST Elevation ACS Undergoing Medical Management by Dr. Walter Desmet

Pre-PCI Treatment Comparison

      -Clopidogrel Pretreatment Versus Clopidogrel Exposure Prior to PCI in teh ACUITY Trial: Does it Really Matter? by Dr. Steven R. Steinhubl

Predictors of Major Vascular Access Site Complications

      -In Patients with ACS Undergoing PCI by Dr. Steven V. Manoukian (TCT 2007)

A Report from the ACUITY Trial

      -Implications of Preoperative Thienopyridine Use Prior to CABG in Patients with ACS by Dr. Ramin Ebrahimi

Safety and Effiacy of Switching Medications

      -Switching from UFH/Enox to Bivalirudin in Patients Undergoing PCI by Dr. Harvey White (AHA 2006)

      -Switching from Either UFH or Enoxaparin Plus a GP IIb/IIIa Inhibitor to Bivalirudin Monotherapy in Patients with Non-ST Elevation ACS Managed with an Invasive Strategy by Dr. Harvey D. White (TCT 2007)

Subacute Stent Thrombosis

      -In Patients with Acute Coronary Syndromes Treated with Bare Metal and Drug-Eluting Stents by Dr. Jiro Aoki

Time Dependence of Antithrombin Initiation

      -The Time Dependence of Antithrombin Initiation in Patients with Non-ST-segment-elevation ACS by Dr. Deborah B. Diercks

Timing of Clopidogrel Treatment

      -Influence of Timing of Clopidogrel Treatment on the Efficacy and Safety of Bivalirudin in Patients with NSTE-ACS Undergoing PCI by Dr. AM Lincoff

Transfusion Results

      -Transfusion is Associated with Increased 30-Day Mortality and Ischemic Complications in Non-ST Elevation Acute Coronary Syndromes by Dr. Steven V. Manoukian (TCT 2006)

      -Impact of Transfusion on One-Year Ischemic Events and Mortality among Patients with ACS Undergoing PCI by Dr. Steven V. Manoukian (TCT 2007)

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 HORIZONS AMI Focus Center

Bivalirudin is not currently labeled for use in ST elevation MI. Shown below are trial data evaluating its use.

30-Day Results

      -A Prospective, Randomized Comparison of Bivalirudin vs. Heparin Plus Glycoprotein IIb/IIIa Inhibitors During Primary Angioplasty in Acute Myocardial Infarction by Dr. Gregg W. Stone (TCT 2007)

Major Adverse Events in STEMI Patients

      -Treated with Primary Angioplasty Occur More Frequently at U.S. Compared with Non U.S. Sites by Dr. Bruce R. Brodie (ACC 2008)

MRI Substudy Results

      -Infarct Size after Primary Angioplasty Patients With Bivalirudin Compared to Unfractionated Heparin Plus Abciximab in STEMI by Dr. Jochen Wöhrle (TCT 2009)

One-Year Results

      -A Prospective, Randomized Comparison of Bivalirudin vs. Heparin Plus Glycoprotein IIb/IIIa Inhibitors During Primary Angioplasty in Acute Myocardial Infarction by Dr. Roxana Mehran (TCT 2008)

      -A Prospective, Randomized Comparison of Paclitaxel-eluting TAXUS Stents vs. Bare Metal Stents During Primary Angioplasty in Acute Myocardial Infarction by Dr. Gregg W. Stone (TCT 2008)

      -Presention at a Non-PCI Facility Requiring Transfer on Long-Term Prognosis in STEMI Patients Undergoing Primary Angioplasty: 1-Year Results Presented at TCT 2009 by Dr. Jochen Wöhrle

      -Primary Angioplasty in Acute Anterior Myocardial Infarction with Bivalirudin Compared to Unfractionated Heparin plus GP IIb/IIIa Inhibitors by Dr. Jochen Wöhrle (TCT 2009)

Predictors of Acute, Subacute and Late Stent Thrombosis

      -After Acute MI Primary Angioplasty in the Horizons AMI Trial by Dr. George D. Dangas

      -Stent Thrombosis Following Primary PCI in STEMI: Predictors, Clinical Impact and Preventive Strategies: Presented at TCT 2009 by Dr. George Dangas

Safety and Effectiveness of Bivalirudin in Patients with Acute MI Undergoing Primary Angioplasty

      -Impact of Diabetes Mellitus by Dr. Bernhard Witzenbichler (ACC 2008)

      -Impact of Clopidogrel Loading Dose by Dr. George Dangas (ACC 2008)

      -Impact of Gender by Dr. L. Grinfield (ACC 2008)

      -Impact of Baseline Renal Function by Dr. Roxana Mehran (ACC 2008)

      -Impact of Advanced Age by Dr. Dariusz Dudek (ACC 2008)

Two-Year Results

      -Two-Year Follow-Up From a Prospective, Randomized Trial of Heparin Plus Glycoprotein IIb/IIa Inhibitors vs. Bivalirudin and Paclitaxel-Eluting vs. Bare Metal Stents in STEMI by Dr. Gregg W. Stone (TCT 2009)

 

Three-Year Results

    -Three-Year Follow-up from a Prospective Randomized Trial of Antithrombin Strategies and Drug-Eluting Stents in Patients with Acute Myocardial Infarction Undergoing Primary Angioplasty by Dr. Gregg W. Stone (TCT 2010)

      -Final 3-Year Results by Dr. Gregg W. Stone

 

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 Other Trials of Bivalirudin in STEMI

BIAMI: A Study Evaluating the Safety of Bivalirudin In the Management of Patients with ST-Segment Elevation Acute Myocardial Infarction Undergoing Primary PCI

      -Trial Overview

 

BRAVO: Effect of Bivalirudin on Aortic Valve Intervention Outcomes

      -Trial Results by Dr. George Dangas

 

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