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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 everolimus eluting stent
    		•  

    BASKET-PROVE (EES) study, 2010

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

    Treatments

    Studied treatment second generation everolimus-eluting stent
    Xience V, Abbott Vascular
    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 774 / 765 (studied vs. control)
    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
    Remarks

    Remarks / Comments



    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 25 / 774 (3,2%) 34 / 765 (4,4%) 0,73 [0,44;1,21]
    Death From cardiac causes 13 / 774 (1,7%) 22 / 765 (2,9%) 0,58 [0,30;1,15]
    Nonfatal myocardial infarction 13 / 774 (1,7%) 20 / 765 (2,6%) 0,64 [0,32;1,28]
    Death from cardiac causes or nonfatal myocardial infarction 25 / 774 (3,2%) 37 / 765 (4,8%) 0,67 [0,41;1,10]
    Death from cardiac causes or nonfatal myocardial infarction 0�6 mo 10 / 774 (1,3%) 21 / 765 (2,7%) 0,47 [0,22;0,99]
    Death from cardiac causes or nonfatal myocardial infarction 7�24 mo 15 / 774 (1,9%) 16 / 765 (2,1%) 0,93 [0,46;1,86]
    Any Target-vessel revascularization 29 / 774 (3,7%) 79 / 765 (10,3%) 0,36 [0,24;0,55]
    Target-vessel revascularization Not related to myocardial infarction 24 / 774 (3,1%) 68 / 765 (8,9%) 0,35 [0,22;0,55]
    Target-vessel revascularization Related to myocardial infarction 5 / 774 (0,6%) 11 / 765 (1,4%) 0,45 [0,16;1,29]
    Death, myocardial infarction, or target-vessel revascularization 59 / 774 (7,6%) 99 / 765 (12,9%) 0,59 [0,43;0,80]
    Definite Stent thrombosis 2 / 774 (0,3%) 6 / 765 (0,8%) 0,33 [0,07;1,63]
    Definite or probable Stent thrombosis 5 / 774 (0,6%) 9 / 765 (1,2%) 0,55 [0,18;1,63]
    Definite, probable, or possible Stent thrombosis 12 / 774 (1,6%) 13 / 765 (1,7%) 0,91 [0,42;1,99]

    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

    25 / 774
         37 / 765
         0,67 [0,41;1,10]

    All cause death

    25 / 774
         34 / 765
         0,73 [0,44;1,21]

    cardiac death

    13 / 774
         22 / 765
         0,58 [0,30;1,15]

    MI (fatal and non fatal)

    13 / 774
         20 / 765
         0,64 [0,32;1,28]

    target-vessel revascularization

    29 / 774
         79 / 765
         0,36 [0,24;0,55]

    4y stent thrombosis (ARC)

    2 / 774
         6 / 765
         0,33 [0,07;1,63]

    Stent thrombosis (any, end of follow up)

    12 / 774
         13 / 765
         0,91 [0,42;1,99]

    2 yr Death (all cause)

    25 / 774
         34 / 765
         0,73 [0,44;1,21]

    2 yr MACE

    25 / 774
         37 / 765
         0,67 [0,41;1,10]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    MACE 25 / 774 (3,2%) 37 / 765 (4,8%) 0,67 [0,41;1,10] Death from cardiac causes or nonfatal myocardial infarction
    All cause death 25 / 774 (3,2%) 34 / 765 (4,4%) 0,73 [0,44;1,21] Death From any cause
    cardiac death 13 / 774 (1,7%) 22 / 765 (2,9%) 0,58 [0,30;1,15] Death From cardiac causes
    MI (fatal and non fatal) 13 / 774 (1,7%) 20 / 765 (2,6%) 0,64 [0,32;1,28] Nonfatal myocardial infarction
    target-vessel revascularization 29 / 774 (3,7%) 79 / 765 (10,3%) 0,36 [0,24;0,55] Any Target-vessel revascularization
    4y stent thrombosis (ARC) 2 / 774 (0,3%) 6 / 765 (0,8%) 0,33 [0,07;1,63] Definite Stent thrombosis
    Stent thrombosis (any, end of follow up) 12 / 774 (1,6%) 13 / 765 (1,7%) 0,91 [0,42;1,99] Definite, probable, or possible Stent thrombosis
    2 yr Death (all cause) 25 / 774 (3,2%) 34 / 765 (4,4%) 0,73 [0,44;1,21] Death From any cause
    2 yr MACE 25 / 774 (3,2%) 37 / 765 (4,8%) 0,67 [0,41;1,10] 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 3,23% 4,84% -16,1‰
    All cause death 3,23% 4,44% -12,1‰
    cardiac death 1,68% 2,88% -12,0‰
    MI (fatal and non fatal) 1,68% 2,61% -9,3‰
    target-vessel revascularization 3,75% 10,33% -65,8‰
    4y stent thrombosis (ARC) 2,58‰ 7,84‰ -5,3‰
    Stent thrombosis (any, end of follow up) 1,55% 1,70% -1,5‰
    2 yr Death (all cause) 3,23% 4,44% -12,1‰
    2 yr MACE 3,23% 4,84% -16,1‰

    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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