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Related trials

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ISAR-DESIRE-2, 2010 - sirolimus ES vs paclitaxel ES

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ZEST (vs PES), 2009 - zotarolimus ES vs paclitaxel ES

PASEO, 2009 - drug ES vs bare-metal stent

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ZEST AMI (vs PES), 2009 - zotarolimus ES vs paclitaxel ES

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COMPARE, 2009 - everolimus ES vs paclitaxel ES

ISAR TEST 3 (BP), 2009 - biodegradable-polymer sirolimus stent vs sirolimus ES

ZEST (vs SES), 2009 - zotarolimus ES vs sirolimus ES

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ISAR-TEST-4, 2009 - sirolimus biodegradable polymer vs sirolimus ES

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MISSION, 2008 - sirolimus ES vs bare-metal stent



See also:

  • All coronary artery disease clinical trials
  • All stable angina clinical trials
  • All clinical trials of revascularization with drug eluting stent
  • All clinical trials of paclitaxel ES
    		•  

    TAXUS II study, 2003

    [NCT00299026]

    Treatments

    Studied treatment TAXUS
    Two paclitaxel-eluting release formulations were evaluated, TAXUS-SR (slow release) and TAXUS-MR (moderate release), which has an 8-fold higher 10-day drug release.
    Control treatment NIR stent
    Concomittant treatment Clopidogrel (or ticlopidine) 6 months
    Treatments description
    molécule paclitaxel, polymeric 

    Patients

    Patients Stable or unstable AP, silent ischaemia; single de novo target lesion with estimatedstenosis >50% and <99%,
    Baseline characteristics
    age 62 
    diabetes (%) 15% 
    lesion length (mm) 10.6 (3.9) 
    %QCA follow-up 97 
    QCA follow-up duration 6 
    reference-vessel diameter 2.8 (0.40) 
    lesion length inclusion criteria <=12 
    Lesion diameter inclusion criteria 3.0-3.5 
    Female (%) 24% 

    Method and design

    Randomized effectives 266 / 270 (studied vs. control)
    Design Parallel groups
    Blinding double-blind
    Follow-up duration 12 months
    Number of centre 38
    Geographic area Global
    Primary endpoint Neointimal proliferation


    Results

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

    All cause death

    0 / 226
         2 / 270
         classic 0,13 [0,00;8,24]

    MI (fatal and non fatal)

    6 / 226
         3 / 270
         classic 2,39 [0,60;9,45]

    target lesion revascularisation

    11 / 260
         38 / 263
         0,29 [0,15;0,56]

    angiographic restenosis

    NA / 266
         NA / 270

    late stent thrombosis (31days - 1year)

    2 / 266
         0 / 270
         classic 9,14 [0,15;567,21]

    MACE

    27 / 260
         57 / 263
         0,48 [0,31;0,73]

    Stent thrombosis (any, end of follow up)

    5 / 226
         0 / 270
         classic 25,09 [0,46;1 381,28]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    All cause death 0 / 226 (0,2%) 2 / 270 (0,7%) 0,30 [0,01;6,59]    
    MI (fatal and non fatal) 6 / 226 (2,7%) 3 / 270 (1,1%) 2,39 [0,60;9,45]    
    MACE 27 / 260 (10,4%) 57 / 263 (21,7%) 0,48 [0,31;0,73]    
    angiographic restenosis 19 / 266 (7,1%) 59 / 270 (21,9%) 0,33 [0,20;0,53]    
    target lesion revascularisation 11 / 260 (4,2%) 38 / 263 (14,4%) 0,29 [0,15;0,56]    
    Stent thrombosis (any, end of follow up) 5 / 226 (2,2%) 0 / 270 (0,2%) 11,95 [0,66;217,51]    
    late stent thrombosis (31days - 1year) 2 / 266 (0,8%) 0 / 270 (0,2%) 4,06 [0,18;89,62]   3831 
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 3831: Moreno R, Fernandez C, Hernandez R, Alfonso F, Angiolillo DJ, Sabate M, Escaned J, Banuelos C, Fernandez-Ortiz A, Macaya CDrug-eluting stent thrombosis: results from a pooled analysis including 10 randomized studies.J Am Coll Cardiol 2005 Mar 15;45:954-9
  • 0:

    • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    MI (fatal and non fatal) 2,65% 1,11% 1,5%
    MACE 10,38% 21,67% -112,9‰
    angiographic restenosis 7,14% 21,85% -147,1‰
    target lesion revascularisation 4,23% 14,45% -102,2‰


    Reference(s)

    Trials register # NCT00299026
    • Colombo A, Drzewiecki J, Banning A, Grube E, Hauptmann K, Silber S, Dudek D, Fort S, Schiele F, Zmudka K, Guagliumi G, Russell ME. Randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for coronary artery lesions.. Circulation 2003;108:788-94
      Pubmed | Hubmed | Fulltext
    • Silber S, Colombo A, Banning AP, Hauptmann K, Drzewiecki J, Grube E, Dudek D, Baim DS. Final 5-year results of the TAXUS II trial: a randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for de novo coronary artery lesions.. Circulation 2009 Oct 13;120:1498-504
      Pubmed | Hubmed | Fulltext

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