SORTOUT III A Prospective Randomized Comparison of ZotarolimusEluting

SORT-OUT III: A Prospective Randomized Comparison of Zotarolimus-Eluting and Sirolimus-Eluting Stents in Patients with Coronary Artery Disease Jens Flensted Lassen, Klaus Rasmussen, Anders Galløe, Per Thayssen, Henning Kelbæk, Jan Ravkilde, Ulrik Abildgaard, Lisette Okkels Jensen, Evald Høj Christiansen, Knud Nørregaard Hansen, Hans Henrik Tilsted, Peter Riis Hansen, Lars Romer Krusell, Thomas Engstrøm, Jens Aarøe, Jan Skov Jensen, Hans Erik Bøtker, Steen Dalby Kristensen, Steen Z Abildstrøm, Anne Kaltoft, Michael Maeng, Morten Madsen, Søren Paaske Johnsen & Leif Thuesen

Method The study III was performed within the framework of the Danish Organization for Randomized Trials with Clinical Outcome (SORT OUT). We designed the study to reflect daily clinical practice. Therefore, no control angiography or study related patient contact were scheduled. We used patient driven clinical event detection, through the Danish Civil Registration system, the National Patient Registry and the Danish Heart Registries.

PCI Organization in Denmark Population of 5, 5 million inhabitants 5 high volume PCI centers PCI center Dual anti-platelet therapy in 12 mo. Danish Civil Registration System & National Patient Registry, Danish Heart Registries • • • cause of death hospital admission diagnosis at discharge coronary angiography PCI CABG 100 US miles

Selected Lesion Characteristics Cypher Endeavor p No of treated vessels/pt 1. 3 +/- 0. 6 1. 4 +/- 0. 8 ns No of lesions/pt 1. 5 +/- 0. 8 1. 6 +/- 0. 9 ns Lesion length (mm) (16. 2 +/- 10. 8) (16. 4 +/-10. 5) ns Stents per lesion (n) 1. 7 +/- 1. 1 ns Stent length (mm) (19. 9 +/- 12. 1) (19. 7 +/- 11. 0) ns Stent diameter (mm) 3. 3 +/- 0. 5 ns Lesion type A (%) 14. 3 16. 2 ns Lesion type B (%) 44. 8 43. 0 ns Lesion type C (%) 40. 9 40. 8 ns Procedure time (min) GPIIb. IIIa treatment (%) 31. 0 +/- 20. 4 18. 9 1. 8 +/- 1. 1 31. 6 +/- 22. 8 16. 2 ns ns

Cardiac Mortality Hazard Ratio (95% CI) 2. 17 (0. 75 – 6. 24) p=0. 14

Myocardial Infarction Hazard Ratio (95% CI) 3. 47 (1. 14 – 10. 5) p=0. 03

Definite Stent Thrombosis Hazard Ratio (95% CI) 4. 62 (1. 33 – 16. 1) p=0. 02

Clinically Significant Restenosis Hazard Ratio (95% CI) 6. 59 (2. 57 – 16. 9) p<0. 0001

Conclusion In the SORT-OUT III all-comers RCT using patient driven clinical event detection, we found increased rates of: a. target lesion revascularization • myocardial infarction • definite stent thrombosis in the Zotarolimus-Eluting Endeavor stent as compared to the Sirolimus-Eluting Cypher stent.