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Systematic review and meta-analysis

This trial is included in the following systematic reviews and meta-analyses:

coronary artery disease - Drug eluting stent - all type of patients


Related trials

BASKET-PROVE (SES), 2010 - sirolimus eluting stent vs bare-metal stent

GISSOC II, 2010 - sirolimus eluting stent vs bare-metal stent

RESOLUTE All comers, 2010 - zotarolimus eluting stent vs everolimus eluting stent

SORT-OUT-3, 2010 - zotarolimus eluting stent vs sirolimus eluting stent

SPIRIT IV, 2010 - everolimus eluting stent vs paclitaxel eluting stent

BASKET-PROVE (EES), 2010 - everolimus eluting stent vs bare-metal stent

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

Thiele, 2009 - sirolimus ES vs MIDCAB

ENDEAVOR IV, 2009 - zotarolimus eluting stent vs paclitaxel eluting stent

ZEST AMI (vs PES), 2009 - zotarolimus eluting stent vs paclitaxel eluting stent

COMPARE, 2009 - everolimus eluting stent vs paclitaxel eluting stent

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

ZEST (vs PES), 2009 - zotarolimus eluting stent vs paclitaxel eluting stent

ZEST (vs SES), 2009 - zotarolimus eluting stent vs sirolimus eluting stent

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

ISAR-TEST-4 (biodegradable polymer), 2009 - sirolimus biodegradable polymer vs sirolimus eluting stent

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

SYNTAX, 2009 - paclitaxel eluting stent vs CABG

PASEO, 2009 - drug-eluting stents vs bare-metal stent

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

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

ISAR-LEFT-MAIN, 2009 - sirolimus eluting stent vs paclitaxel eluting stent

SORT OUT II, 2008 - sirolimus eluting stent vs paclitaxel eluting stent

DES-DIABETES, 2008 - sirolimus eluting stent vs paclitaxel eluting stent

TRIAS-HR, 2008 - Genous stent vs paclitaxel eluting stent



See also:

  • All coronary artery disease clinical trials
  • All clinical trials of Drug eluting stent
  • All clinical trials of sirolimus eluting stent
  •  

    BASKET-PROVE (SES) study, 2010

    [ISRCTN72444640] download pdf: sirolimus eluting stent | Drug eluting stent for coronary artery disease

    Treatments

    Studied treatment first-generation sirolimus-eluting stent
    Cypher Select, Cordis
    Control treatment BMS
    cobalt–chromium stent Vision, Abbott Vascular
    Concomittant treatment aspirin at a daily dose of 75 to 100 mg indefinitely and clopidogrel at a daily dose of 75 mg for 1 year, after a loading dose of 300 mg or 600 mg, regardless of stent type
    Remarks 3 arms: sirolimus-eluting, everolimus-eluting and bare metal stent

    Patients

    Patients patients needing stents 3.0 mm or larger
    Inclusion criteria chronic or acute coronary disease; angioplasty with stenting; stents that were 3.0 mm or more in diameter; without restrictions on the number of treated lesions or vessels, the length of treated lesions, or the number of stents placed
    Exclusion criteria cardiogenic shock; in-stent restenosis or thrombosis of stents placed before the study; unprotected left main coronary artery (i.e., with no functioning bypass graft) or substantial stenosis in a bypass graft; plans for any surgery within 12 months; need for oral anticoagulation, increased risk of bleeding, or known intolerance to or suspected noncompliance with long-term antiplatelet therapy; circumstances that would have made follow-up impossible.
    Baseline characteristics
    age 67y 
    history of MI (%) 12% 
    diabetes (%) 16% 
    Smoker (%) 32% (current) 
    unstable angina (%) 32% 
    LAD (%) 52% 
    RCA (%) 41% 
    LCx (%) 27% 
    male (%) 75% 
    lesion length inclusion criteria any 
    Lesion diameter inclusion criteria >=3mm 
    Female (%) 25% 
    left main coronary artery disease 1% (with bypass graft) 
    totally occluded lesions 5% 
    bifurcated lesions 8% 
    STEMI 33% 
    Stable angina 35% 
    multi vessels patients 43% 
    No of lesions per patients 1.45 

    Method and design

    Randomized effectives 775 / 765 (studied vs. control)
    Design Parallel groups
    Blinding open
    Follow-up duration 2 years
    Geographic area Switzerland, Denmark, Austria, Italy
    Hypothesis Superiority
    Primary endpoint death from cardiac causes or nonfatal myocardial at 2y


    Results



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

    Endpoint Events (%) Relative Risk 95% CI
    Studied treat. Control treat.
    Death From any cause 28 / 775 (3,6%) 34 / 765 (4,4%) 0,81 [0,50;1,33]
    Death From cardiac causes 13 / 775 (1,7%) 22 / 765 (2,9%) 0,58 [0,30;1,15]
    Death Nonfatal myocardial infarction 7 / 775 (0,9%) 20 / 765 (2,6%) 0,35 [0,15;0,81]
    Death from cardiac causes or nonfatal myocardial infarction 20 / 775 (2,6%) 37 / 765 (4,8%) 0,53 [0,31;0,91]
    Death from cardiac causes or nonfatal myocardial infarction 0–6 mo 11 / 775 (1,4%) 21 / 765 (2,7%) 0,52 [0,25;1,07]
    Death from cardiac causes or nonfatal myocardial infarction 7–24 mo 9 / 775 (1,2%) 16 / 765 (2,1%) 0,56 [0,25;1,25]
    Any Target-vessel revascularization 33 / 775 (4,3%) 79 / 765 (10,3%) 0,41 [0,28;0,61]
    Target-vessel revascularization Not related to myocardial infarction 29 / 775 (3,7%) 68 / 765 (8,9%) 0,42 [0,28;0,64]
    Target-vessel revascularization Related to myocardial infarction 4 / 775 (0,5%) 11 / 765 (1,4%) 0,36 [0,11;1,12]
    Death, myocardial infarction, or target-vessel revascularization 61 / 775 (7,9%) 99 / 765 (12,9%) 0,61 [0,45;0,82]
    Definite Stent thrombosis 3 / 775 (0,4%) 6 / 765 (0,8%) 0,49 [0,12;1,97]
    Definite or probable Stent thrombosis 6 / 775 (0,8%) 9 / 765 (1,2%) 0,66 [0,24;1,84]
    Definite, probable, or possible Stent thrombosis 11 / 775 (1,4%) 13 / 765 (1,7%) 0,84 [0,38;1,85]

    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]

    MACE

    20 / 775
    37 / 765
    0,53 [0,31;0,91]

    All cause death

    28 / 775
    34 / 765
    0,81 [0,50;1,33]

    cardiac death

    13 / 775
    22 / 765
    0,58 [0,30;1,15]

    MI (fatal and non fatal)

    7 / 775
    20 / 765
    0,35 [0,15;0,81]

    target-vessel revascularization

    33 / 775
    79 / 765
    0,41 [0,28;0,61]

    4y stent thrombosis (ARC)

    3 / 775
    6 / 765
    0,49 [0,12;1,97]

    Stent thrombosis (any, end of follow up)

    11 / 775
    13 / 765
    0,84 [0,38;1,85]

    2 yr MACE

    20 / 775
    37 / 765
    0,53 [0,31;0,91]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    MACE 20 / 775 (2,6%) 37 / 765 (4,8%) 0,53 [0,31;0,91] Death from cardiac causes or nonfatal myocardial infarction
    All cause death 28 / 775 (3,6%) 34 / 765 (4,4%) 0,81 [0,50;1,33] Death From any cause
    cardiac death 13 / 775 (1,7%) 22 / 765 (2,9%) 0,58 [0,30;1,15] Death From cardiac causes
    MI (fatal and non fatal) 7 / 775 (0,9%) 20 / 765 (2,6%) 0,35 [0,15;0,81] Death Nonfatal myocardial infarction
    target-vessel revascularization 33 / 775 (4,3%) 79 / 765 (10,3%) 0,41 [0,28;0,61] Any Target-vessel revascularization
    4y stent thrombosis (ARC) 3 / 775 (0,4%) 6 / 765 (0,8%) 0,49 [0,12;1,97] Definite Stent thrombosis
    Stent thrombosis (any, end of follow up) 11 / 775 (1,4%) 13 / 765 (1,7%) 0,84 [0,38;1,85] Definite, probable, or possible Stent thrombosis
    2 yr MACE 20 / 775 (2,6%) 37 / 765 (4,8%) 0,53 [0,31;0,91] Death from cardiac causes or nonfatal myocardial infarction
    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.
    MACE 2,58% 4,84% -22,6‰
    All cause death 3,61% 4,44% -8,3‰
    cardiac death 1,68% 2,88% -12,0‰
    MI (fatal and non fatal) 9,03‰ 2,61% -17,1‰
    target-vessel revascularization 4,26% 10,33% -60,7‰
    4y stent thrombosis (ARC) 3,87‰ 7,84‰ -4,0‰
    Stent thrombosis (any, end of follow up) 1,42% 1,70% -2,8‰
    2 yr MACE 2,58% 4,84% -22,6‰

    Meta-analysis of all similar trials:

    Drug eluting stent in coronary artery disease for all type of patients



    Reference(s)

    Trials register # ISRCTN72444640
    • Kaiser C, Galatius S, Erne P, Eberli F, Alber H, Rickli H, Pedrazzini G, Hornig B, Bertel O, Bonetti P, De Servi S, Brunner-La Rocca HP, Ricard I, Pfisterer M. Drug-Eluting versus Bare-Metal Stents in Large Coronary Arteries.. N Engl J Med 2010 Nov 16;: - 10.1056/NEJMoa1009406
      Pubmed | Hubmed | Fulltext

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