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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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