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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
  •  

    REPLACE-1 study, 2004

    download pdf: bivalirudin | antithrombotics for percutaneous coronary intervention

    Treatments

    Studied treatment bivalirudin (0.75 mg/kg bolus, 1.75 mg/kg/h infusion during the procedure
    Control treatment heparin (70 U/kg initial bolus) adjusted to ACT of 200 to 300s
    Concomittant treatment aspirin; pretreatment with clopidogrel encouraged,and GPIIb/IIIa inhibitors at physician’s discretion

    Patients

    Patients patients undergoing elective or urgent revascularization
    Exclusion criteria ongoing acute myocardial infarction or conditions of elevated bleeding risk,3 or if they had received unfractionated heparin within 6 hours (unless aPTT measured within 2 hours before randomization was <=50 seconds), low molecular weight heparin within 12 hours, abciximab within 7 days, or eptifibatide or tirofiban within 12 hours

    Method and design

    Randomized effectives 532 / 524 (studied vs. control)
    Design Parallel groups
    Follow-up duration hospital stay (48h min)
    Number of centre 77
    Geographic area US
    Hypothesis NA
    Primary endpoint death, MI, repeat revascularization

    Remarks / Comments

    pilot study of replace 2



    Results

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

    All cause death

    0 / 532
    3 / 524
    classic 0,08 [0,00;4,42]

    Unplanned revascularisation for ischaemia

    4 / 532
    7 / 524
    0,56 [0,17;1,91]

    death, MI, unplanned revascularization

    30 / 532
    36 / 524
    0,82 [0,51;1,31]

    MI (fatal and non fatal)

    26 / 532
    27 / 524
    0,95 [0,56;1,60]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    death, MI, unplanned revascularization 30 / 532 (5,6%) 36 / 524 (6,9%) 0,82 [0,51;1,31]
    MI (fatal and non fatal) 26 / 532 (4,9%) 27 / 524 (5,2%) 0,95 [0,56;1,60]
    All cause death 0 / 532 (0,1%) 3 / 524 (0,6%) 0,16 [0,01;3,27]
    Unplanned revascularisation for ischaemia 4 / 532 (0,8%) 7 / 524 (1,3%) 0,56 [0,17;1,91] Urgent revascularization
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:

    Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    death, MI, unplanned revascularization 5,64% 6,87% -12,3‰
    MI (fatal and non fatal) 4,89% 5,15% -2,7‰
    Unplanned revascularisation for ischaemia 7,52‰ 1,34% -5,8‰

    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 # NA
    • Lincoff AM, Bittl JA, Kleiman NS, Sarembock IJ, Jackman JD, Mehta S, Tannenbaum MA, Niederman AL, Bachinsky WB, Tift-Mann J, Parker HG, Kereiakes DJ, Harrington RA, Feit F, Maierson ES, Chew DP, Topol EJ, , . Comparison of bivalirudin versus heparin during percutaneous coronary intervention (the Randomized Evaluation of PCI Linking Angiomax to Reduced Clinical Events [REPLACE]-1 trial).. Am J Cardiol 2004;93:1092-6. - 10.1016/j.amjcard.2004.01.033
      Pubmed | Hubmed | Fulltext

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