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Related trials

SPIRIT IV, 2010 - everolimus ES vs paclitaxel ES

SORT-OUT-3, 2010 - zotarolimus ES vs sirolimus ES

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

RESOLUTE, 2010 - zotarolimus ES vs everolimus ES

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

PASEO, 2009 - drug ES vs bare-metal stent

Thiele, 2009 - sirolimus ES vs MIDCAB

ISAR TEST 2 (vs ZES), 2009 - dual sirolimus, probucol ES vs zotarolimus ES

ISAR TEST 3 (PF), 2009 - polymer free sirolimus stent vs sirolimus ES

ENDEAVOR IV, 2009 - zotarolimus ES vs paclitaxel ES

GENIUS-STEMI, 2009 - Genous stent vs bare-metal stent

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

STICH (ventricular reconstruction), 2009 - CABG+surgical ventricular reconstruction vs CABG

ISAR TEST 2 (vs SES), 2009 - dual sirolimus, probucol ES vs sirolimus ES

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

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

BARI 2D, 2009 - CABG or PCI vs medical treatment

DEBATER (SES vs BMS), 2009 - sirolimus ES vs bare-metal stent

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

SYNTAX, 2009 - paclitaxel ES vs CABG

ISAR-LEFT-MAIN, 2009 - sirolimus ES vs paclitaxel ES

Kim, 2008 - sirolimus ES vs paclitaxel ES

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, non-polymeric ES
    		•  

    PATENCY study, 2002

    unpublished (or not yet fully published) trial

    Treatments

    Studied treatment Logic PTX paclitaxel Eluting CoronaryStents
    Control treatment uncoated control stents
    Concomittant treatment Clopidogrel 3 months
    Treatments description
    molécule paclitaxel, non polymeric 

    Patients

    Patients Patients with de novo lesions of 2.7- to 4.0-mm diameter and 25-mm length received 3.0, 3.5, or 4.0 mm 10- or 15-mm
    Exclusion criteria vein grafts, severe calcification, severe proximal tortuosity, angulation 90°, thrombus, myocardial infarction (MI) within 72 hours, in-stent restenosis, ostial location, bifurcation lesions, and staged procedures
    Baseline characteristics
    age 66y 
    diabetes (%) 25 
    LAD (%) 40% 
    RCA (%) 28% 
    LCx (%) 32% 
    lesion length (mm) NA 
    %QCA follow-up 76 
    QCA follow-up duration 9 
    male (%) 64% 
    reference-vessel diameter 2.77 (0.45) 
    lesion length inclusion criteria <25mm 
    Lesion diameter inclusion criteria 2.7-4 mm 

    Method and design

    Randomized effectives 24 / 26 (studied vs. control)
    Design Parallel groups
    Blinding double blind
    Follow-up duration 9 months
    Number of centre multicenter
    Primary endpoint NA


    Results

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

    All cause death

    0 / 24
         1 / 26
         classic 0,22 [0,00;15,31]

    MI (fatal and non fatal)

    0 / 24
         0 / 26
         classic 1,08 [0,00;269,33]

    target lesion revascularisation

    0 / 24
         1 / 26
         classic 0,22 [0,00;15,31]

    angiographic restenosis

    NA / 21
         NA / 17

    MACE

    3 / 24
         6 / 26
         0,54 [0,15;1,93]

    Stent thrombosis (any, end of follow up)

    0 / 24
         0 / 26
         classic 1,08 [0,00;269,33]     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 / 24 (2,1%) 1 / 26 (3,8%) 0,54 [0,02;15,43]    
    MI (fatal and non fatal) 0 / 24 (2,1%) 0 / 26 (1,9%) 1,08 [0,02;52,49]    
    MACE 3 / 24 (12,5%) 6 / 26 (23,1%) 0,54 [0,15;1,93]    
    target lesion revascularisation 0 / 24 (2,1%) 1 / 26 (3,8%) 0,54 [0,02;15,43]    
    angiographic restenosis 8 / 21 (38,1%) 6 / 17 (35,3%) 1,08 [0,46;2,51]    
    Stent thrombosis (any, end of follow up) 0 / 24 (2,1%) 0 / 26 (1,9%) 1,08 [0,02;52,49]    
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 0:

    • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    MACE 12,50% 23,08% -105,8‰
    angiographic restenosis 38,10% 35,29% 2,8%


    Reference(s)

    unpublished (or not yet fully published) trial

    Trials register # NA
    • Heldman A, Farhat N, Fry E, et al.b. Paclitaxel-eluting stent for cytostatic prevention of restenosis: the PATENCY Study . Transcatheter Cardiovascular Therapeutics Annual Meeting,September, 2002
      Pubmed | Hubmed | Fulltext

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