NEWS HIGHLIGHTSMedia Articles Related to Angiomax (Bivalirudin)
AHA: Newer Anticoagulants Beat Heparin for PCI (CME/CE)
Source: MedPage Today Cardiovascular [2009.11.19]
ORLANDO (MedPage Today) -- Acute myocardial infarction patients pretreated with anticoagulants before percutaneous coronary interventions appear to fare better with fondaparinux or enoxaparin than unfractionated heparin, researchers reported.
AHA: Low Bleeding Rates Observed in Dabigatran Dose-Ranging Trial (CME/CE)
Source: MedPage Today Cardiovascular [2009.11.19]
ORLANDO (MedPage Today) -- The oral anticoagulant dabigatran did not appear to markedly increase major bleeding rates among post-MI patients who were already being treated with aspirin and clopidogrel (Plavix), researchers said here.
ASTRO: Blood Thinners May Lower PSA Failure Risk (CME/CE, with video)
Source: MedPage Today Hematology/Oncology [2009.11.10]
CHICAGO (MedPage Today) -- Patients with localized prostate cancer had significantly better biochemical control if they were taking an anticoagulant or antiplatelet agent following radiation therapy, according to a study reported here.
Young Women With Autoimmune Condition Need To Be Warned About The Dangers Of Smoking And Use Of Oral Contraceptives
Source: Lupus News From Medical News Today [2009.09.28]
An article published Online First and in the November edition of The Lancet Neurology reports that women with a particular subtype of antibody called lupus anticoagulant (LA) have a more than 40-fold increased risk of stroke. Moreover, they have a 5-fold increased risk of heart attack compared with the general population of young women. The autoimmune condition antiphospholipid syndrome mostly affects young women.
Published Studies Related to Angiomax (Bivalirudin)
Bivalirudin in patients undergoing primary angioplasty for acute myocardial infarction (HORIZONS-AMI): 1-year results of a randomised controlled trial. [2009.10.03]
BACKGROUND: In the HORIZONS-AMI trial, patients with acute ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI) who were treated with the thrombin inhibitor bivalirudin had substantially lower 30-day rates of major haemorrhagic complications and net adverse clinical events than did patients assigned to heparin plus a glycoprotein IIb/IIIa inhibitor (GPI). Here, we assess whether these initial benefits were maintained at 1 year of follow-up... INTERPRETATION: In patients with STEMI undergoing primary PCI, anticoagulation with bivalirudin reduced the rates of net adverse clinical events and major bleeding at 1 year compared with treatment with heparin plus a GPI. This finding has important clinical implications for the selection of optimum treatment strategies for patients with STEMI. FUNDING: Cardiovascular Research Foundation, with unrestricted grant support from Boston Scientific Corporation and The Medicines Company.
A comparison of anticoagulation with bivalirudin and provisional GPIIb/IIIa inhibition with unfractionated heparin and mandatory GPIIb/IIIa inhibition during percutaneous coronary intervention in relation to platelet activation and the inhibition of coagulation. [2009.08]
CONCLUSIONS: Bivalirudin has some early advantages on platelet activation when compared to UFH. However, there are significant limitations in its mechanism of action, particularly a lack of release of tissue factor pathway inhibitor.
Bivalirudin and clopidogrel with and without eptifibatide for elective stenting: effects on platelet function, thrombelastographic indexes, and their relation to periprocedural infarction results of the CLEAR PLATELETS-2 (Clopidogrel with Eptifibatide to Arrest the Reactivity of Platelets) study. [2009.02.24]
OBJECTIVES: The primary objective of this study was to compare the effect of therapy with bivalirudin alone versus bivalirudin plus eptifibatide on platelet reactivity measured by turbidometric aggregometry and thrombin-induced platelet-fibrin clot strength (TIP-FCS) measured by thrombelastography in percutaneous coronary intervention (PCI) patients. The secondary aim was to study the relation of platelet aggregation and TIP-FCS to the occurrence of periprocedural infarction. BACKGROUND: Bivalirudin is commonly administered alone to clopidogrel naive (CN) patients and to patients on maintenance clopidogrel therapy (MT) undergoing elective stenting. The effect of adding eptifibatide to bivalirudin on platelet reactivity (PR) and TIP-FCS, and their relation to periprocedural infarction in these patients are unknown... CONCLUSIONS: For elective stenting, the addition of eptifibatide to bivalirudin lowered PR to multiple agonists and the tensile strength of the TIP-FCS, 2 measurements strongly associated with periprocedural myonecrosis. Future studies of PR and TIP-FCS for elective stenting may facilitate personalized antiplatelet therapy and enhance the selection of patients for glycoprotein IIb/IIIa blockade. (Peri-Procedural Myocardial Infarction, Platelet Reactivity, Thrombin Generation, and Clot Strength: Differential Effects of Eptifibatide + Bivalirudin Versus Bivalirudin [CLEAR PLATELETS-2]; NCT00370045.
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 and Urgent Intervention Triage strategY) trial. [2008.12]
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... 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).
Economic evaluation of bivalirudin with or without glycoprotein IIb/IIIa inhibition versus heparin with routine glycoprotein IIb/IIIa inhibition for early invasive management of acute coronary syndromes. [2008.11.25]
OBJECTIVES: The aim of this study was to determine the economic impact of several anticoagulation strategies for moderate- and high-risk non-ST-segment elevation acute coronary syndrome (NSTE-ACS) patients managed invasively. BACKGROUND: The ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trial demonstrated that bivalirudin monotherapy yields similar rates of ischemic complications and less bleeding than regimens incorporating glycoprotein IIb/IIIa receptor inhibitors (GPI) for moderate- and high-risk NSTE-ACS... CONCLUSIONS: Among U.S. patients in the ACUITY trial, bivalirudin monotherapy compared with heparin + GPI resulted in similar protection from ischemic events, reduced bleeding, and shorter length of stay. Despite higher drug costs, aggregate hospital and 30-day costs were lowest with bivalirudin monotherapy. Thus bivalirudin monotherapy seems to be an economically attractive alternative to heparin + GPI for patients with moderate- and high-risk NSTE-ACS. (Comparison of Angiomax Versus Heparin in Acute Coronary Syndromes [ACS]; NCT00093158).
Clinical Trials Related to Angiomax (Bivalirudin)
Study Of Angiomax In Infants Under Six Months With Thrombosis [Completed]
The goals of this study are:
1. To assess the safety of bivalirudin in infants under six months with arterial or venous
thrombosis;
2. To determine the dose of bivalirudin required to achieve adequate anticoagulation as
measured by the activated clotting time (ACT) or activated partial thromboplastin time
(aPTT) in Infants Under Six Months with arterial or venous thrombosis;
3. To determine the outcome of patients on bivalirudin with respect to thrombus resolution
and bleeding complications compared to patients on unfractionated heparin (UH) or low
molecular weight heparin (LMWH).
Comparison of Angiomax Versus Heparin in Acute Coronary Syndromes (ACS) [Completed]
The purpose of this study is to show that, when compared with heparin (enoxaparin or
unfractionated heparin) and routine GPIIb/IIIa inhibition (either started upfront or at the
time of percutaneous coronary intervention [PCI]; Arm A):
1. Bivalirudin with routine GPIIb/IIIa inhibition (either started upfront or at the time of
PCI; Arm B) provides non-inferior or superior overall clinical outcomes and
2. Bivalirudin alone (Arm C) reduces clinically significant bleeding. An important
secondary objective for this comparison is to show that bivalirudin is not inferior for
ischemic complications.
Angiomax in Patients With HIT/HITTS Type II Undergoing CPB [Active, not recruiting]
The purpose of this study is to demonstrate that in patients with heparin-induced
thrombocytopenia (HIT)/heparin-induced thrombocytopenia and thrombosis syndrome (HITTS) Type
II undergoing cardiac surgery on cardiopulmonary bypass (CPB), Angiomax is a safe and
effective anticoagulant.
Comparing Angiomax to Heparin With Protamine Reversal in Patients OPCAB [Active, not recruiting]
The purpose of this study is to examine the safety and efficacy of Angiomax as an alternative
anticoagulant to heparin with protamine reversal in patients undergoing off-pump coronary
artery bypass graft surgery.
Comparing Angiomax to Heparin With Protamine in Patients Undergoing Cardiopulmonary Bypass (CPB) [Completed]
The purpose of this study is to demonstrate that in patients undergoing coronary artery
bypass grafting (CABG) or CABG-Valve, or Isolated Cardiac Valve surgery on CPB (cardiac
surgery), Angiomax is a safe and effective alternative anticoagulant to heparin with
protamine reversal.
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