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.

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

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): 409-16. This is the Bulleted List slide. To create this particular slide, click the NEW SLIDE button on your toolbar and choose the BULLETED LIST format. (Top row, second from left) The Sub-Heading and footnote will not appear when you insert a new slide. If you need either one, copy and paste it from the sample slide. If you choose not to use a Sub-Heading, let us know when you hand in your presentation for clean-up and we’ll adjust where the bullets begin on your master page. Also, be sure to insert the presentation title onto the BULLETED LIST MASTER as follows: Choose View / Master / Slide Master from your menu. Select the text at the bottom of the slide and type in a short version of your presentation title. Click the SLIDE VIEW button in the lower left hand part of your screen to return to the slide show. (Small white rectangle) 2 2

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. 2004 – Jan. 2006 (498 days)

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

MACE rates at 3 years

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

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

Stent thrombosis rates at 3 years

1½ and 3 year results 1½ y. ST HR 0.90 CI 0.54-1.51 1½ y. MACE HR 0.83 CI 0.63-1.08 3 y. MACE HR 0.87 CI 0.70-1.07 No apparent change from 1½ to 3 year

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

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 % This is the Bulleted List slide. To create this particular slide, click the NEW SLIDE button on your toolbar and choose the BULLETED LIST format. (Top row, second from left) The Sub-Heading and footnote will not appear when you insert a new slide. If you need either one, copy and paste it from the sample slide. If you choose not to use a Sub-Heading, let us know when you hand in your presentation for clean-up and we’ll adjust where the bullets begin on your master page. Also, be sure to insert the presentation title onto the BULLETED LIST MASTER as follows: Choose View / Master / Slide Master from your menu. Select the text at the bottom of the slide and type in a short version of your presentation title. Click the SLIDE VIEW button in the lower left hand part of your screen to return to the slide show. (Small white rectangle) 11

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% This is the Bulleted List slide. To create this particular slide, click the NEW SLIDE button on your toolbar and choose the BULLETED LIST format. (Top row, second from left) The Sub-Heading and footnote will not appear when you insert a new slide. If you need either one, copy and paste it from the sample slide. If you choose not to use a Sub-Heading, let us know when you hand in your presentation for clean-up and we’ll adjust where the bullets begin on your master page. Also, be sure to insert the presentation title onto the BULLETED LIST MASTER as follows: Choose View / Master / Slide Master from your menu. Select the text at the bottom of the slide and type in a short version of your presentation title. Click the SLIDE VIEW button in the lower left hand part of your screen to return to the slide show. (Small white rectangle) 12 12