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  • Sort out iii

    1. 1. SORT-OUT III: A Prospective Randomized Comparison of Zotarolimus-Eluting and Sirolimus-Eluting Stents in Patients with Coronary Artery Disease Michael Maeng, Klaus Rasmussen, Per Thayssen,Henning Kelbæk, Jan Ravkilde, Ulrik Abildgaard, Lisette O. Jensen, Evald H. Christiansen, Knud N. Hansen, Hans-Henrik Tilsted, Peter R. Hansen, Lars R. Krusell,Thomas Engstrøm, Jens Aarøe, Jan S. Jensen, Hans E.Bøtker, Steen D. Kristensen, Steen Z. Abildstrøm, Anne Kaltoft, Morten Madsen, Søren P. Johnsen, Henrik T. Sørensen, Leif Thuesen & Jens F. Lassen
    2. 2. SORT-OUT III: A Prospective Randomized Comparison of Zotarolimus-Eluting and Sirolimus-Eluting Stents in Patients with Coronary Artery Disease Conflicts of interests for Michael Maeng, M.D. Cordis, Johnson & Johnson: Speaker fees. Medtronic: Consultant fee
    3. 3. Background• Three published studies (Endeavor III, ISAR- TEST-2, ZEST-AMI) have shown that the zotarolimus-eluting Endeavor stent (END) is inferior to the sirolimus-eluting Cypher stent (CYP) with regard to angiographic endpoints - None of these studies were powered to assess clinical endpoints
    4. 4. PurposeTo compare the clinical outcome in routineclinical care (“all-comer”) patients randomizedto Endeavor or Cypher stent implantation
    5. 5. PCI Organization in Denmark PCI centerPopulation of 5,5 million inhabitants5 high volume PCI centers12-month dual anti-platelet therapyis recommended 100 US miles
    6. 6. Methods• The study was performed within the framework ofthe Danish Organization for Randomized Trialswith Clinical Outcome (SORT OUT)• We designed the study to reflect daily clinicalpractice. Therefore, no control angiography orstudy-related patient contact were scheduled• We used patient driven clinical event detectionby use of the Danish Civil Registration system, theNational Patient Registry, and the Danish HeartRegistries
    7. 7. MethodsInclusion: Indication for treatment with a DESExclusion: Inability to provide informed consent Life expectancy < 1 year Allergy to aspirin or clopidogrel Participation in another trial
    8. 8. EndpointsPrimary endpoint: A composite of cardiac mortality, myocardial infarction (MI), and target vessel revascularization (TVR)Secondary endpoints: All cause mortality Cardiac mortality MI Definite stent thrombosis (ARC definition) TVR Target lesion revascularization (TLR)
    9. 9. Results• 2,332 patients were enrolled• Complete 18-month follow-up in 2,200 (94%) patients
    10. 10. Selected Patient Characteristics END CYPNo of patients 1.162 1.170Age (yrs) 64 64Male (%) 73 72Diabetes (%) 15 14Hypertension (%) 54 51Lipid-lowering therapy (%) 70 68Previous CABG (%) 7 7Previous PCI (%) 21 17Previous MI (%) 26 27
    11. 11. PCI Indication END CYPStable angina (%) 53 51NSTEMI/UAP (%) 38 38STEMI (%) 6 9Other (%) 4 3
    12. 12. Selected Lesion Characteristics END CYPNo of lesions/patient 1.6 1.5Stents/patient 1.8 1.7Lesion length (mm) 13 14Stent length (mm) 18 18Stent diameter (mm) 3.2 3.2Lesion type A (%) 20 18Lesion type B (%) 45 48Lesion type C (%) 36 35
    13. 13. MACEHR = 2.19 (1.58 – 3.04) END : 9.7%P < 0.0001 CYP : 4.5%
    14. 14. All Cause Mortality HR = 1.61 (1.03 – 2.50) P = 0.035 END : 4.4% CYP : 2.7%
    15. 15. Cardiac Death HR = 1.51 (0.73 – 3.14) P = 0.27 END : 1.6% CYP : 1.0%
    16. 16. Myocardial Infarction HR = 2.22 (1.09 – 4.53) P = 0.029 END : 2.1% CYP : 0.9%
    17. 17. Definite Stent Thrombosis HR = 2.19 (0.83 – 5.77) P = 0.13 END : 1.1% CYP : 0.5%
    18. 18. Target Vessel Revascularization HR = 2.42 (1.67 – 3.52) P<0.0001 END : 7.9% CYP : 3.3%
    19. 19. Target Lesion Revascularization HR = 3.66 (2.23 – 6.01) P < 0.0001 END : 6.1% CYP : 1.7%
    20. 20. ConclusionThe Endeavor stent was inferior to theCypher stent in routine clinical care (“all-comer”) patients at 18-month follow-up
    21. 21. For further details …..The SORT OUT III 18-month manuscript ispublished on-line in The Lancet today Thank you for your attention

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