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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

ISAR-REACT 3, 2008 - bivalirudin vs UFH

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

STEEPLE, 2006 - enoxaparin vs UFH

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

JUMBO-TIMI 26, 2005 - prasugrel vs clopidogrel

REPLACE-1, 2004 - bivalirudin vs UFH

Natarajan (without antiGp2b3a), 2003 - Dalteparin vs UFH

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

CRUISE, 2003 - Enoxaparin vs UFH

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

Petronio, 2002 - Abciximab vs placebo

Tamburino, 2002 - Abciximab vs placebo

Kleiman, 2002 - bivalirudin + eptifibatide vs heparin + eptifibatide

CADILLAC, 2002 - Abciximab vs placebo

Galeote, 2001 - Enoxaparin vs UFH

Drozd, 2001 - Enoxaparin vs UFH

Kini, 2001 - Abciximab vs placebo

Dubek b (+abciximal), 2001 - Enoxaparin+abciximab vs UFH

ADMIRAL, 2001 - Abciximab vs placebo

ESPRIT, 2000 - Eptifibatide vs placebo



See also:

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

    NAPLES (Tavano) study, 2009

    download pdf: bivalirudin | antithrombotics for percutaneous coronary intervention

    Treatments

    Studied treatment bivalirudin monotherapy
    Control treatment unfractionated heparin plus tirofiban

    Patients

    Patients patients with diabetes mellitus undergoing elective percutaneous coronary intervention
    Inclusion criteria age >=18 years old, biabetes treated with insulin and/or oral agents, de novo coronary lesion in a native coronary artery, and elective PCI
    Exclusion criteria PCI performed as reperfusion therapy for acute myocardial infarction; pregnancy; recent (<1 month) PCI; restenotic lesion; saphenous venous graft and/or mammary artery lesion intervention; acute coronary syndrome with basal creatine kinase or creatine kinase-myocardial band value greater than the upper limit of local normal;recent (<=12 weeks) active internal bleeding or bleeding diathesis, surgery, trauma, or gastrointestinal or genitourinary tract bleeding; previous intracranial bleeding or structural abnormality; platelet count <=125 10^3/µl; history of heparininduced thrombocytopenia; chronic kidney disease with serum creatinine levels >3 mg/dl or dependency on renal dialysis; warfarin therapy; and administration of UFH within 6 hours, low-molecular-weight heparin within 8 hours, abciximab within 7 days, or eptifibatide or tirofiban within 12 hours before randomization

    Method and design

    Randomized effectives 167 / 168 (studied vs. control)
    Design Parallel groups
    Blinding open
    Follow-up duration 30 days
    Number of centre single center
    Geographic area Italy
    Primary endpoint MACE


    Results



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

    Endpoint Events (%) Relative Risk 95% CI
    Studied treat. Control treat.
    death, urgent revascularization, myocardial infarction, bleeding 30 / 167 (18,0%) 53 / 168 (31,5%) 0,57 [0,38;0,84]
    Death 0 / 167 (0,3%) 0 / 168 (0,3%) 1,01 [0,02;50,41]
    Not calculable (data not available)
    Q-wave myocardial infarction 0 / 167 (0,3%) 0 / 168 (0,3%) 1,01 [0,02;50,41]
    Non–Q-wave myocardial infarction 17 / 167 (10,2%) 21 / 168 (12,5%) 0,81 [0,45;1,49]
    Urgent coronary revascularization 0 / 167 (0,3%) 0 / 168 (0,3%) 1,01 [0,02;50,41]
    Stent thrombosis 0 / 167 (0,3%) 0 / 168 (0,3%) 1,01 [0,02;50,41]
    any bleeding 14 / 167 (8,4%) 35 / 168 (20,8%) 0,40 [0,22;0,72]
    Major Bleeding 1 / 167 (0,6%) 4 / 168 (2,4%) 0,25 [0,03;2,23]
    Mino rBleeding 13 / 167 (7,8%) 31 / 168 (18,5%) 0,42 [0,23;0,78]

    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]

    All cause death

    0 / 167
    0 / 168
    classic 1,01 [0,00;256,10]

    Minor bleeding

    13 / 167
    31 / 168
    0,42 [0,23;0,78]

    Major bleeding

    1 / 167
    4 / 168
    classic 0,25 [0,03;2,23]

    Unplanned revascularisation for ischaemia

    0 / 167
    0 / 168
    classic 1,01 [0,00;256,10]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    Minor bleeding 13 / 167 (7,8%) 31 / 168 (18,5%) 0,42 [0,23;0,78] Mino rBleeding
    Major bleeding 1 / 167 (0,6%) 4 / 168 (2,4%) 0,25 [0,03;2,23] Major Bleeding
    All cause death 0 / 167 (0,3%) 0 / 168 (0,3%) 1,01 [0,02;50,41] Death
    Unplanned revascularisation for ischaemia 0 / 167 (0,3%) 0 / 168 (0,3%) 1,01 [0,02;50,41] Urgent coronary 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.
    Minor bleeding 7,78% 18,45% -106,7‰
    Major bleeding 5,99‰ 2,38% -17,8‰

    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
    • Tavano D, Visconti G, D'Andrea D, Focaccio A, Golia B, Librera M, Caccavale M, Ricciarelli B, Briguori C. Comparison of bivalirudin monotherapy versus unfractionated heparin plus tirofiban in patients with diabetes mellitus undergoing elective percutaneous coronary intervention.. Am J Cardiol 2009;104:1222-8
      Pubmed | Hubmed | Fulltext

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