SORT-OUT III: A Prospective Randomized Comparison of Zotarolimus-Eluting and Sirolimus-Eluting Stents in Patients with Cor...
Conflicts of interests for Michael Maeng, M.D. Cordis, Johnson & Johnson:   Speaker fees. Medtronic:   Consultant fee SORT...
Background <ul><li>Three published studies (Endeavor III, ISAR-TEST-2, ZEST-AMI) have shown that the zotarolimus-eluting E...
Purpose  To compare the clinical outcome in routine clinical care (“all-comer”) patients randomized to Endeavor or Cypher ...
PCI Organization in Denmark Population of 5,5 million inhabitants  5 high volume PCI centers 12-month dual anti-platelet t...
Methods  <ul><li>The study was performed within the framework of the Danish Organization for Randomized Trials with Clinic...
Methods <ul><li>Inclusion:   Indication for treatment with a DES </li></ul><ul><li>Exclusion:   I nability to provide info...
Endpoints <ul><li>Primary endpoint: A composite of cardiac mortality, myocardial infarction (MI), and target vessel revasc...
Results <ul><li>2,332 patients were enrolled </li></ul><ul><li>Complete 18-month follow-up in 2,200 (94%) patients </li></ul>
Selected Patient Characteristics 26 21 7 70 54 15 73 64 1.162 END CYP No of patients 1.170 Age (yrs) 64 Male (%) 72 Diabet...
PCI Indication END CYP Stable angina (%) 53 51 NSTEMI/UAP (%) 38 38 STEMI (%) 6 9 Other (%) 4 3
Selected Lesion Characteristics 1.5 1.6 No of lesions/patient 1.7 1.8  Stents/patient 36 45 20 3.2  18 13 END CYP Lesion l...
MACE HR = 2.19 (1.58 – 3.04) P < 0.0001 END  : 9.7% CYP  : 4.5%
All Cause Mortality HR = 1.61 (1.03 – 2.50) P = 0.035 END  : 4.4% CYP  : 2.7%
Cardiac Death HR = 1.51 (0.73 – 3.14) P = 0.27 END  : 1.6% CYP  : 1.0%
Myocardial Infarction HR = 2.22 (1.09 – 4.53) P = 0.029 END  : 2.1% CYP  : 0.9%
Definite Stent Thrombosis HR = 2.19 (0.83 – 5.77) P = 0.13 END  : 1.1% CYP  : 0.5%
Target Vessel Revascularization HR = 2.42 (1.67 – 3.52) P<0.0001 END  : 7.9% CYP  : 3.3%
Target Lesion Revascularization HR = 3.66 (2.23 – 6.01) P < 0.0001 END  : 6.1% CYP  : 1.7%
Conclusion  <ul><li>The Endeavor stent was inferior to the Cypher stent in routine clinical care (“all-comer”) patients at...
For further details ….. <ul><li>The SORT OUT III 18-month manuscript is published on-line in  The Lancet  today </li></ul>...
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    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. Conflicts of interests for Michael Maeng, M.D. Cordis, Johnson & Johnson: Speaker fees. Medtronic: Consultant fee SORT-OUT III: A Prospective Randomized Comparison of Zotarolimus-Eluting and Sirolimus-Eluting Stents in Patients with Coronary Artery Disease
    3. 3. Background <ul><li>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 </li></ul>
    4. 4. Purpose To compare the clinical outcome in routine clinical care (“all-comer”) patients randomized to Endeavor or Cypher stent implantation
    5. 5. PCI Organization in Denmark Population of 5,5 million inhabitants 5 high volume PCI centers 12-month dual anti-platelet therapy is recommended PCI center 100 US miles
    6. 6. Methods <ul><li>The study was performed within the framework of the Danish Organization for Randomized Trials with Clinical Outcome (SORT OUT) </li></ul><ul><li>We designed the study to reflect daily clinical practice. Therefore, no control angiography or study-related patient contact were scheduled </li></ul><ul><li>We used patient driven clinical event detection by use of the Danish Civil Registration system, the National Patient Registry, and the Danish Heart Registries </li></ul>
    7. 7. Methods <ul><li>Inclusion: Indication for treatment with a DES </li></ul><ul><li>Exclusion: I nability to provide informed consent </li></ul><ul><li>Life expectancy < 1 year </li></ul><ul><li>Allergy to aspirin or clopidogrel </li></ul><ul><li>Participation in another trial </li></ul>
    8. 8. Endpoints <ul><li>Primary endpoint: A composite of cardiac mortality, myocardial infarction (MI), and target vessel revascularization (TVR) </li></ul><ul><li>Secondary endpoints: All cause mortality </li></ul><ul><li>Cardiac mortality </li></ul><ul><li>MI </li></ul><ul><li>Definite stent thrombosis (ARC definition) </li></ul><ul><li>TVR Target lesion revascularization (TLR) </li></ul>
    9. 9. Results <ul><li>2,332 patients were enrolled </li></ul><ul><li>Complete 18-month follow-up in 2,200 (94%) patients </li></ul>
    10. 10. Selected Patient Characteristics 26 21 7 70 54 15 73 64 1.162 END CYP No of patients 1.170 Age (yrs) 64 Male (%) 72 Diabetes (%) 14 Hypertension (%) 51 Lipid-lowering therapy (%) 68 Previous CABG (%) 7 Previous PCI (%) 17 Previous MI (%) 27
    11. 11. PCI Indication END CYP Stable angina (%) 53 51 NSTEMI/UAP (%) 38 38 STEMI (%) 6 9 Other (%) 4 3
    12. 12. Selected Lesion Characteristics 1.5 1.6 No of lesions/patient 1.7 1.8 Stents/patient 36 45 20 3.2 18 13 END CYP Lesion length (mm) 14 Stent length (mm) 18 Stent diameter (mm) 3.2 Lesion type A (%) 18 Lesion type B (%) 48 Lesion type C (%) 35
    13. 13. MACE HR = 2.19 (1.58 – 3.04) P < 0.0001 END : 9.7% 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. Conclusion <ul><li>The Endeavor stent was inferior to the Cypher stent in routine clinical care (“all-comer”) patients at 18-month follow-up </li></ul>
    21. 21. For further details ….. <ul><li>The SORT OUT III 18-month manuscript is published on-line in The Lancet today </li></ul>Thank you for your attention

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