1. Long-term safety and efficacy of zotarolimus-eluting and sirolimus-eluting stents in routine clinical care patients 36-month follow-up in the SORT OUT III trial
Michael Maeng, Hans-Henrik Tilsted, Anne Kaltoft,
Lisette O. Jensen, Henning Kelbæk, Anton B. Villadsen, Evald H. Christiansen, Lars R. Krusell, Peter R. Hansen, Knud N. Hansen, Jens Aarøe, Jan S. Jensen, Steen D. Kristensen, Hans E. Bøtker, Per Thayssen, Morten Madsen, Henrik T. Sørensen, Jan Ravkilde, Leif Thuesen, Jens F. Lassen, on behalf of the
SORT OUT III investigators 1

2. 18-Month Results. Lancet 2010;375:1090-1099
“The sirolimus-eluting stent is superior to the zotarolimus-eluting stent for patients receiving routine clinical care” 2

3. Endeavor vs. Cypher
Six published randomized studies have uniformly shown that the zotarolimus-eluting Endeavor stent (END) is associated with increased rates of TLR as compared to the sirolimus-eluting Cypher (CYP) stent
Very late stent thrombosis (VLST) is an increasingly important safety issue and this issue remains to be conclusively addressed with these DESs 3 3

4. Purpose
To compare the 36-month clinical outcomes in routine clinical care (“all-comer”) patients randomized to END or CYP stent implantation 4

5. PCI organization in Denmark
PCI center
100 US miles
Population of 5.5 million inhabitants
5 high volume PCI centers
12-month dual anti-platelet therapy is recommended

6. Methods Inclusion criteria Indication for treatment with a DES
Exclusion criteria Inability to provide informed consent Life expectancy < 1 year Allergy to aspirin or clopidogrel Participation in another trial
Ascertained from 7

7. Endpoints
Major adverse cardiac events (MACE) defined as a composite of cardiac mortality, myocardial infarction (MI), or target vessel revascularization (TVR)
All cause mortality
Cardiac mortality MI
Definite stent thrombosis (ARC definition)
TVR
Target lesion revascularization (TLR)

8. Results 2,332 patients were enrolled
Complete 36-month follow-up data for 2,323 patients
9 patients emigrated and were censored on the day of emigration 9

9. Selected Patient Characteristics
END
CYP
No of patients
1162
1170
Age (yrs) 64
Male (%) 73 72
Diabetes mellitus (%) 15 14
Hypertension (%) 54 51
Lipid-lowering therapy (%) 70 68
Previous CABG (%) 7
Previous PCI (%) 21 17
Previous MI (%) 26 27

10. PCI Indication END CYP Stable angina (%) 53 51 NSTEMI/UAP (%) 386 9
Other (%) 4 3

11. MACE
HR = 1.33 (1.04 – 1.69)
P = 0.02
END : 12.9%
CYP : 10.1% 13

12. All Cause Mortality HR = 1.25 (0.91 – 1.72) P = 0.17 END : 7.3%
CYP : 5.9% 14 14

13. Cardiac Death HR = 1.02 (0.62 – 1.66) P = 0.95 END : 2.8% CYP : 2.8%15

14. Myocardial Infarction
HR = 1.19 (0.77 – 1.85)
P = 0.44
END : 3.8%
CYP : 3.3% 16

15. Definite Stent Thrombosis
P = 0.61
CYP : 1.4%
END : 1.1% 17

16. Target Vessel Revascularization
HR = 1.40 (1.04 – 1.89)
P = 0.02
END : 9.1%
CYP : 6.7% 18

17. Target Lesion Revascularization
HR = 1.82 (1.25 – 2.63)
P = 0.002
END : 6.8%
CYP : 3.9% 19 19

18. Landmark Analysis – Definite ST
HR = 3.28 P = 0.038
Fisher’s exact test P =
Cypher: ≈ 0.5% VLST/year
END : 1.1%
CYP : 1.1%
CYP : 0.3%
END : 0.0% 20

19. Conclusion
The Cypher stent remains superior to the Endeavor stent at 36-month follow-up with regard to MACE, TVR and TLR

20. Conclusion
The Cypher stent remains superior to the Endeavor stent at 36-month follow-up with regard to MACE, TVR and TLR
In comparison to the Endeavor stent, the Cypher stent is associated with an increased risk of very late stent thrombosis (≈0.5%/year)

21. Thank you for your attention
Conclusion
The Cypher stent remains superior to the Endeavor stent at 36-month follow-up with regard to MACE, TVR and TLR
In comparison to the Endeavor stent, the Cypher stent is associated with an increased risk of VLST (≈0.5%/year)
Thank you for your attention