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Systematic review and meta-analysis

This trial is included in the following systematic reviews and meta-analyses:

percutaneous coronary intervention - anticoagulant - all type of patients

percutaneous coronary intervention - antithrombotics - all type of patients


Related trials

ATOLL, 2010 - enoxaparin vs standard heparin

TRA-PCI, 2009 - SCH 530348 vs placebo

NAPLES (Tavano), 2009 - bivalirudin vs actionated heparin plus tirofiban

CHAMPION-PCI, 2009 - cangrelor up front vs clopidogrel up front

CHAMPION-PLATFORM, 2009 - cangrelor up front vs delayed clopidogrel

HORIZONS-AMI (Stone), 2008 - bivalirudin vs heparin + GP2b3a inhibitors

ISAR-REACT 3, 2008 - bivalirudin vs UFH

Hull, 2006 - extended tinzaparin vs standard treatment

INTERACT, 2006 - enoxaparin vs UFH (on top of aspirin)

Deitcher, 2006 - extended enoxaparin vs standard treatment

ACUITY (Stone) (bivalirudin alone), 2006 - bivalirudin vs heparin + GP2b3a inhibitors

STEEPLE, 2006 - enoxaparin vs UFH

EVET, 2005 - enoxaparin vs tinzaparin

Wells (subgroup), 2005 - tinzaparin vs dalteparin

Daskalopoulos, 2005 - LMWH at home vs UFH in hospital

Chong, 2005 - LMWH at home vs UFH in hospital

JUMBO-TIMI 26, 2005 - prasugrel vs clopidogrel

REPLACE-1, 2004 - bivalirudin vs UFH

Ramacciotti, 2004 - LMWH at home vs UFH in hospital

THE-PRINCE (Kleber), 2003 - enoxaparin vs UFH

REPLACE-2, 2003 - bivalirudin vs hepatin + anti Gp2b3a

Natarajan (without antiGp2b3a), 2003 - Dalteparin vs UFH

Cesarone, 2003 - extended enoxaparin vs standard treatment

CRUISE, 2003 - Enoxaparin vs UFH

Natarajan (+ antiGp2b3a), 2003 - Dalteparin vs UFH + anti Gp2b3a



See also:

  • All percutaneous coronary intervention clinical trials
  • All clinical trials of antithrombotics
  • All clinical trials of bivalirudin
    		•  

    HORIZONS-AMI (Stone) study, 2008

    [NCT00433966] download pdf: bivalirudin | antithrombotics for percutaneous coronary intervention

    Treatments

    Studied treatment Bivalirudin
    bivalirudin intravenous bolus of 0.75 mg per kilogram, followed by an infusion of 1.75 mg per kilogram per hour
    Control treatment Heparin plus GP IIb/IIIa inhibitor
    heparin intravenous bolus of 60 IU per kilogram of body weight, with subsequent boluses targeted to an activated clotting time of 200 to 250 seconds glycoprotein IIb/IIIa inhibitor was administered before PCI in all the patients in the control group but was to be administered in the bivalirudin group only in patients with no reflow or with giant thrombus after PCI. Either abciximab (a bolus of 0.25 mg per kilogram followed by an infusion of 0.125 �g per kilogram per minute; maximum dose, 10 �g per minute) or doublebolus eptifibatide (a bolus of 180 �g per kilogram followed by an infusion of 2.0 �g per kilogram per minute, with a second bolus given 10 minutes after the first; no maximum dose prespecified), adjusted for renal impairment according to the label, was permitted at the discretion of the investigator and was continued for 12 hours (abciximab) or 12 to 18 hours (eptifibatide)
    Concomittant treatment Aspirin (324 mg given orally or 500 mg administered intravenously) was given in the emergency room, after which 300 to 325 mg was given orally every day during the hospitalization, and 75 to 81 mg every day thereafter indefinitely. A loading dose of clopidogrel (either 300 mg or 600 mg, at the discretion of the investigator), or ticlopidine (500 mg), in the case of allergy to clopidogrel, was administered before catheterization, followed by 75 mg orally every day for at least 6 months (1 year or longer recommended)
    Treatments description
    Bivalirudin as Antithrombin during PCI 96.9% / 0.2%  
    stent implanted (%) 95.5% 

    Patients

    Patients patients with ST-segment elevation myocardial infarction who presented within 12 hours after the onset of symptoms and who were undergoing primary PCI
    Baseline characteristics
    Age (mean), years 60.2 y 
    male (%) 76.6% 
    Previous PCI 10.7% 
    Previous CABG 2.95% 
    Weight (kg) 80 kg 
    Hypertension (%) 53.5% 
    Left anterior descending coronary artery 40.7% 
    Left circumfl ex coronary artery 15.8% 
    Right coronary artery 42% 
    Unstable angina / ACS 0% 

    Method and design

    Randomized effectives 1800 / 1802 (studied vs. control)
    Design Parallel groups
    Blinding open
    Follow-up duration 30 days
    Number of centre 123
    Geographic area 11 countries
    Hypothesis Superiority
    Primary endpoint MACE, major bleeding


    Results



    Endpoints and data reported in the trial's publication(s)

    Endpoint Events (%) Relative Risk 95% CI
    Studied treat. Control treat.
    Major adverse cardiovascular events 98 / 1800 (5,4%) 99 / 1802 (5,5%) 0,99 [0,76;1,30]
    Death 37 / 1800 (2,1%) 56 / 1802 (3,1%) 0,66 [0,44;1,00]
    Cardiac death 32 / 1800 (1,8%) 52 / 1802 (2,9%) 0,62 [0,40;0,95]
    Noncardiac death 5 / 1800 (0,3%) 4 / 1802 (0,2%) 1,25 [0,34;4,65]
    Reinfarction 33 / 1800 (1,8%) 32 / 1802 (1,8%) 1,03 [0,64;1,67]
    Q-wave Reinfarction 25 / 1800 (1,4%) 22 / 1802 (1,2%) 1,14 [0,64;2,01]
    Non�Q-wave Reinfarction 8 / 1800 (0,4%) 12 / 1802 (0,7%) 0,67 [0,27;1,63]
    Revascularization of target vessel for ischemia 47 / 1800 (2,6%) 35 / 1802 (1,9%) 1,34 [0,87;2,07]
    Stroke 13 / 1800 (0,7%) 11 / 1802 (0,6%) 1,18 [0,53;2,63]
    Major bleeding, non�CABG-related 89 / 1800 (4,9%) 149 / 1802 (8,3%) 0,60 [0,46;0,77]
    Major bleeding, including CABG-related 122 / 1800 (6,8%) 195 / 1802 (10,8%) 0,63 [0,50;0,78]
    Blood transfusion 37 / 1800 (2,1%) 63 / 1802 (3,5%) 0,59 [0,39;0,88]
    Not calculable (data not available)
    TIMI Major bleeding 55 / 1800 (3,1%) 91 / 1802 (5,0%) 0,61 [0,44;0,84]
    TIMI Minor bleeding 51 / 1800 (2,8%) 82 / 1802 (4,6%) 0,62 [0,44;0,88]
    TIMI Major or minor bleeding 106 / 1800 (5,9%) 173 / 1802 (9,6%) 0,61 [0,49;0,77]
    Not calculable (data not available)
    Life-threatening or severe bleeding (GUSTO classification) 8 / 1800 (0,4%) 11 / 1802 (0,6%) 0,73 [0,29;1,81]
    Moderate bleeding (GUSTO classification) 55 / 1800 (3,1%) 91 / 1802 (5,0%) 0,61 [0,44;0,84]
    Life-threatening, severe, or moderate bleeding (GUSTO classification) 63 / 1800 (3,5%) 101 / 1802 (5,6%) 0,62 [0,46;0,85]
    Not calculable (data not available)
    ModerateThrombocytopenia (<100,000 platelets/mm3) 19 / 1800 (1,1%) 48 / 1802 (2,7%) 0,40 [0,23;0,67]
    SevereThrombocytopenia (<50,000 platelets/mm3) 5 / 1800 (0,3%) 15 / 1802 (0,8%) 0,33 [0,12;0,92]
    Profound Thrombocytopenia (<20,000 platelets/mm3) 0 / 1800 (0,0%) 6 / 1802 (0,3%) 0,08 [0,00;1,49]

    Endpoints used by the meta-analysis and data retained for this trial

    Endpoint Studied treat.
    n/N     Control treat.
    n/N     Graph RR [95% CI]

    net benefit

    166 / 1800
         218 / 1802
         0,76 [0,63;0,92]

    Bleeding

    89 / 1800
         149 / 1802
         0,60 [0,46;0,77]

    death, MI, unplanned revascularization

    98 / 1800
         99 / 1802
         0,99 [0,76;1,30]

    MI (fatal and non fatal)

    25 / 1800
         22 / 1802
         classic 1,14 [0,64;2,01]

    Minor bleeding

    51 / 1800
         82 / 1802
         0,62 [0,44;0,88]

    MACE

    98 / 1800
         99 / 1802
         0,99 [0,76;1,30]

    Major bleeding

    55 / 1800
         91 / 1802
         0,61 [0,44;0,84]

    All cause death

    37 / 1800
         56 / 1802
         0,66 [0,44;1,00]

    Unplanned revascularisation for ischaemia

    47 / 1800
         35 / 1802
         classic 1,34 [0,87;2,07]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    net benefit 166 / 1800 (9,2%) 218 / 1802 (12,1%) 0,76 [0,63;0,92] 9464
    Bleeding 89 / 1800 (4,9%) 149 / 1802 (8,3%) 0,60 [0,46;0,77] Major bleeding, non�CABG-related
    death, MI, unplanned revascularization 98 / 1800 (5,4%) 99 / 1802 (5,5%) 0,99 [0,76;1,30] Major adverse cardiovascular events
    MI (fatal and non fatal) 25 / 1800 (1,4%) 22 / 1802 (1,2%) 1,14 [0,64;2,01] Q-wave Reinfarction
    Minor bleeding 51 / 1800 (2,8%) 82 / 1802 (4,6%) 0,62 [0,44;0,88] TIMI Minor bleeding
    MACE 98 / 1800 (5,4%) 99 / 1802 (5,5%) 0,99 [0,76;1,30] Major adverse cardiovascular events
    Major bleeding 55 / 1800 (3,1%) 91 / 1802 (5,0%) 0,61 [0,44;0,84] TIMI Major bleeding
    All cause death 37 / 1800 (2,1%) 56 / 1802 (3,1%) 0,66 [0,44;1,00] Death
    Unplanned revascularisation for ischaemia 47 / 1800 (2,6%) 35 / 1802 (1,9%) 1,34 [0,87;2,07] Revascularization of target vessel for ischemia
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 9464: Stone GW, Witzenbichler B, Guagliumi G, Peruga JZ, Brodie BR, Dudek D, Kornowski R, Hartmann F, Gersh BJ, Pocock SJ, Dangas G, Wong SC, Kirtane AJ, Parise H, Mehran RBivalirudin during primary PCI in acute myocardial infarction.N Engl J Med 2008 May 22;358:2218-30

    • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    net benefit 9,22% 12,10% -28,8‰
    Bleeding 4,94% 8,27% -33,2‰
    death, MI, unplanned revascularization 5,44% 5,49% -0,5‰
    MI (fatal and non fatal) 1,39% 1,22% 1,7‰
    Minor bleeding 2,83% 4,55% -17,2‰
    MACE 5,44% 5,49% -0,5‰
    Major bleeding 3,06% 5,05% -19,9‰
    All cause death 2,06% 3,11% -10,5‰
    Unplanned revascularisation for ischaemia 2,61% 1,94% 6,7‰

    Meta-analysis of all similar trials:

    anticoagulant in percutaneous coronary intervention for all type of patients

    antithrombotics in percutaneous coronary intervention for all type of patients



    Reference(s)

    Trials register # NCT00433966
    • Mehran R, Brodie B, Cox DA, Grines CL, Rutherford B, Bhatt DL, Dangas G, Feit F, Ohman EM, Parise H, Fahy M, Lansky AJ, Stone GW, . The Harmonizing Outcomes with RevasculariZatiON and Stents in Acute Myocardial Infarction (HORIZONS-AMI) Trial: study design and rationale.. Am Heart J 2008;156:44-56. - 10.1016/j.ahj.2008.02.008
      Pubmed | Hubmed | Fulltext
    • Stone GW, Witzenbichler B, Guagliumi G, Peruga JZ, Brodie BR, Dudek D, Kornowski R, Hartmann F, Gersh BJ, Pocock SJ, Dangas G, Wong SC, Kirtane AJ, Parise H, Mehran R. Bivalirudin during primary PCI in acute myocardial infarction.. N Engl J Med 2008 May 22;358:2218-30
      Pubmed | Hubmed | Fulltext

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