1. American College of Cardiology Presented by Dr. Stephan Windecker
SIRTAX Trial
Sirolimus-eluting Stent compared with Paclitaxel-eluting Stent for Coronary Revascularization
Presented at
American College of Cardiology
Scientific Sessions 2005
Presented by Dr. Stephan Windecker

2. Paclitaxel-eluting Stent
SIRTAX Trial
1012 patients with symptomatic coronary artery disease, presence of at least one lesion covered with one or multiple stents of ≥50% stenosis, and anatomy suitable for coronary stenting
Randomized, single center
Sirolimus-eluting Stent
n=503
Paclitaxel-eluting Stent
n=509
Endpoints (9 months):
MACE: Cardiac death, myocardial infarction (MI), or target lesion revascularization
Presented at ACC Scientific Sessions 2005

3. Target Lesion Revascularization
SIRTAX Trial
Primary Endpoint
(MACE at 9 months)
Hazard Ratio [HR] 1.80
95% CI
p=0.009
MACE Components
Death
p=NS MI
p=0.148
Target Lesion Revascularization
p=0.025 %
The primary endpoint of MACE at 9 months was lower in the sirolimus-eluting stent group vs the paclitaxel-eluting stent.
Individual components of 9 month MACE were death, MI, and target lesion revascularization.
Presented at ACC Scientific Sessions 2005

4. SIRTAX Trial
Target Vessel Failure
p=0.012
Stent
Thrombosis
p=NS
The endpoint of target vessel failure was lower in the sirolimus-eluting stent group.
Stent thrombosis did not differ by treatment group.
Among the subgroup analysis, the treatment benefit in the primary endpoint for the sirolimus-eluting stent group was notably better in diabetics (HR 3.27, p=0.013) than the non-diabetics (HR 1.51, p=0.110).
Baseline clinical and angiographic characteristics were well-matched between the treatment groups.
Presenting syndrome was stable angina in 49% of patients and acute coronary syndromes in 51%, with 22% ST elevation MI.
Device success occurred in 99% of patients. %
Sirolimus
Paclitaxel
Sirolimus
Paclitaxel
Presented at ACC Scientific Sessions 2005

5. SIRTAX Trial Late Lumen Loss Binary Re-stenosis mm
In-stent
p<0.001
In-lesion
p=0.001
In-stent
p=0.013
In-lesion
p=0.02 mm
Sirolimus
Paclitaxel
Sirolimus
Paclitaxel
Sirolimus
Paclitaxel
Sirolimus
Paclitaxel
Among the angiographic cohort, late lumen loss was lower in the sirolimus-eluting stent group compared with the paclitaxel-eluting stent group both in-stent and in-lesion.
Likewise, binary re-stenosis was also lower in the sirolimus-eluting stent group in-stent.
Presented at ACC Scientific Sessions 2005

6. SIRTAX Trial: Summary
Among patients with coronary artery disease, treatment with the sirolimus-eluting stent was associated with a reduction in MACE at 9 months compared to treatment with the paclitaxel-eluting stent, driven primarily by a reduction in the need for target lesion revascularization with a trend toward lower rates of MI and no difference in mortality.
The findings of the SIRTAX trial are discordant with the findings of the REALITY trial, which like SIRTAX demonstrated improvements in the angiographic parameter of late lumen loss with sirolimus-eluting stents, but showed no difference in the primary endpoint of binary re-stenosis or in clinical MACE rates.
Presented at ACC Scientific Sessions 2005

7. SIRTAX Trial: Summary Cont’d
Additionally, stent thrombosis was significantly higher in the paclitaxel-eluting stent group in the REALITY trial (as treated analysis), while no difference in stent thrombosis was observed in the present SIRTAX trial.
While other trials such as ISAR DESIRE and ISAR DIABETES have compared the two drug-eluting stents in a head-to-head comparison for treatment of in-stent restenosis and in diabetics, respectively, the present trial along with the REALITY trial are the first large-scale randomized trial to evaluate the stents in a broader population of patients with coronary artery disease.
Presented at ACC Scientific Sessions 2005