1. Three Years Follow Up. SORT OUT II
Anders Galløe,
Leif Thuesen, Henning Kelbæk, Per Thayssen, Klaus Rasmussen, Peter R. Hansen, Niels Bligaard, Kari Saunamäki, Anders Junker, Jens Aarøe, Ulrik Abildgaard, Jan Ravkilde, Thomas Engstrøm, Jan S. Jensen, Henning R. Andersen, , Hans E. Bøtker, Søren Galatius, Steen D. Kristensen, Jan K. Madsen, Lars R.Krusell, Steen Z. Abildstrøm, Ghita B. Stephansen, Jens F. Lassen, on behalf of the SORT OUT II investigators.
Gentofte University Hospital
Copenhagen, Denmark.

2. Disclosure Cordis, Johnson and Johnson and Boston Scientific
have contributed with unrestricted grants

3. SORT OUT II
A randomized comparison of the clinical outcome of Cypher® or Taxus® stenting in unselected all-comers in everyday clinical practice assessed by symptom driven clinical end points
1½ year results:
Galløe AM et al, JAMA 2008; 299(4):
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4. SORT-OUT participating centers
Catchments area: Denmark (5.4 MIO inhabitants)
PCI centers: All five Danish University Centers
Study population: 2,098 randomized out of 11,749 PCI patients
Randomization period:
Aug – Jan (498 days)

5. Purpose
To compare the Major Adverse Cardiac Event (MACE) and Stent Thrombosis (ST) rates during 3 years of observation in patients randomized to either Taxus® or Cypher® stent implantation

6. MACE rates at 3 years

7. A difference is a difference if it makes a difference
The curves are not superimposed and the apparent difference between the two curves represents a difference of 17 MACE
Out of a total of 352 MACE (16.8%) in 2098 patients followed for 3 years

8. What might we be missing ?
The postulated or missed health gain (remember the ”ns”) may be extracted from the area between the two curves and may be utilized to calculate that:
If a population were to be treated by Cypher® in preference to Taxus® then that population would reach a MACE rate of 16.8 % 109 days later than a similar population treated by Taxus® stenting.
Equal to a gain of approx 3½ months in 3 years

9. Stent thrombosis rates at 3 years

10. 1½ and 3 year results 1½ y. ST HR 0.90 CI 0.54-1.51
1½ y. MACE HR 0.83 CI
3 y. MACE HR 0.87 CI
No apparent change from 1½ to 3 year

11. The Cypher® vs. Taxus® studies
Number of patients randomized

12. Conclusion I
The SORT OUT II is an unselected all comers study with symptom driven clinical end points
There is no statistically significant difference in MACE rates between Cypher® and Taxus®
There is apparently little or no clinically significant difference in MACE rates between Cypher® and Taxus®
The MACE rate after 3 years is 16.8 %
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13. Conclusion II
There is no statistically significant difference in stent thrombosis rate between Cypher® and Taxus®
There is apparently no clinically significant difference in stent thrombosis rates between Cypher® and Taxus®
Stent thrombosis rate after 3 years is 4.2%
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