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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

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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 everolimus ES
    		•  

    SPIRIT I study, 2005

    [NCT00180453]

    Treatments

    Studied treatment everolimus eluting sent, XIENCE
    Control treatment bare etal stent, MULTI-LINK VISION
    Treatments description
    multivessel treatment no 

    Patients

    Patients patients with de novo native coronary artery lesions
    Inclusion criteria RVD 3mm; LL <=12mm
    Baseline characteristics
    lesion length (mm) <=12 mm 
    QCA follow-up duration 1y 
    reference-vessel diameter 3mm 
    single vessel patients 100% 
    multi vessels patients 0% 
    No of lesions per patients 1 

    Method and design

    Randomized effectives 28 / 32 (studied vs. control)
    Design Parallel groups
    Blinding single-blind
    Follow-up duration 6 months (5yr)
    Primary endpoint in-stent late loss


    Results

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

    All cause death

    0 / 28
         0 / 32
         classic 1,14 [0,00;285,43]

    MI (fatal and non fatal)

    1 / 28
         0 / 32
         classic 5,71 [0,08;406,29]

    target lesion revascularisation

    1 / 28
         6 / 32
         0,19 [0,02;1,49]

    Stent thrombosis (any, end of follow up)

    0 / 28
         0 / 32
         classic 1,14 [0,00;285,43]

    MACE

    2 / 28
         6 / 32
         0,38 [0,08;1,74]     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 / 28 (1,8%) 0 / 32 (1,6%) 1,14 [0,02;55,73]    
    MI (fatal and non fatal) 1 / 28 (3,6%) 0 / 32 (1,6%) 2,29 [0,08;65,59]    
    MACE 2 / 28 (7,1%) 6 / 32 (18,8%) 0,38 [0,08;1,74]    
    Stent thrombosis (any, end of follow up) 0 / 28 (1,8%) 0 / 32 (1,6%) 1,14 [0,02;55,73] at 3y   
    target lesion revascularisation 1 / 28 (3,6%) 6 / 32 (18,8%) 0,19 [0,02;1,49]    
    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 7,14% 18,75% -116,1‰
    target lesion revascularisation 3,57% 18,75% -151,8‰


    Reference(s)

    Trials register # NCT00180453
    Study web site link ,
    • Serruys PW, Ong AT, Piek JJ, Neumann FJ, van der Giessen WJ, Wiemer M, Zeiher A, Grube E, Haase J, Thuesen L, Hamm C, Otto-Terlouw PC. A randomized comparison of a durable polymer Everolimus-eluting stent with a bare metal coronary stent: The SPIRIT first trial.. EuroIntervention 2005 May;1:58-65
      Pubmed | Hubmed | Fulltext
    • Tsuchida K, Piek JJ, Neumann FJ, van der Giessen WJ, Wiemer M, Zeiher AM, Grube E, Haase J, Thuesen L, Hamm CW, Veldhof S, Dorange C, Serruys PW. One-year results of a durable polymer everolimus-eluting stent in de novo coronary narrowings (The SPIRIT FIRST Trial).. EuroIntervention 2005 Nov;1:266-72
      Pubmed | Hubmed | Fulltext
    • Tsuchida K, Garca-Garca HM, Ong AT, Valgimigli M, Aoki J, Rademaker TA, Morel MA, van Es GA, Bruining N, Serruys PW. Revisiting late loss and neointimal volumetric measurements in a drug-eluting stent trial: analysis from the SPIRIT FIRST trial.. Catheter Cardiovasc Interv 2006 Feb;67:188-97
      Pubmed | Hubmed | Fulltext

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