1. The American College of Cardiology Presented by Dr. A. Abazid
ZOMAXX-IVUS Trial
Percutaneous Coronary Revascularization Using a Trilayer Phosphorylcholine-coated Zotarolimus-eluting Stent (ZoMaxx IVUS) Trial
Presented at
The American College of Cardiology
Scientific Session 2006
Presented by Dr. A. Abazid

2. ZOMAXX-IVUS Trial: Background
This is a first in-man study evaluating the clinical and angiographic findings using the Phosphorylcholine-coated Zotarolimus-eluting stent.
This trial was designed to assess the rates of angiographic restenosis associated with percutaneous coronary revascularization using the Zotarolimus-eluting stent.
Presented at ACC 2006

3. ZOMAXX-IVUS Trial: Study Design
40 patients with symptomatic ischemic coronary occlusive disease due to single de novo obstructive lesions
45% female, mean age 59 years, mean follow-up 4 months
All patients underwent percutaneous coronary intervention (PCI) using the
3.5 mm x 18 mm Zomaxx stent
Primary Endpoint: Percent in-stent net volume obstruction at 4 months
Secondary Endpoint: Individual and combined endpoints including death, myocardial infarction, ischemia driven revascularization
Presented at ACC 2006

4. ZOMAXX IVUS Trial: Primary Endpoint
Reduction in Diameter Stenosis (%)
Acute Gains (mm)
19±7%
1.86±0.34 mm
1.48±0.38 mm %
5.1±5.3% mm
In-stent and in-segment diameter stenoses were reduced to 5.1±5.3% and 19.0±7.0% respectively.
In-stent and in-segment acute gains were 1.86±0.34 mm and 1.48±0.38 mm.
There were no major adverse cardiac events (MACE) during the study (MACE: composite endpoint of non-Q wave MI, Q-wave MI, ischemia target vessel revascularization and cardiac death).
Presented at ACC 2006

5. ZOMAXX IVUS Trial: Angiographic Endpoints at 4-Months
Reduction in Diameter Stenosis (%)
n=37
Late Loss (mm)
n=37
0.20±0.35 mm
23.0±13%
0.17±0.35 mm % mm
10.0±14%
In a total of 37 patients, in-stent and in-segment diameter stenosis (DS) was 10.0±14% and 23.0±13% respectively.
In-stent and in-segment late loss was 0.20±0.35 mm and 0.17±0.35 mm.
Presented at ACC 2006

6. ZOMAXX-IVUS Trial: Angiographic Endpoints at 4-Months (cont.)
There were no lesion, procedure, and device-deployment failures.
One patient had a diameter stenosis of 55%.
The binary restenosis rate was 5.4%.
There was no evidence of angiographic edge restenosis.
Presented at ACC 2006

7. ZOMAXX IVUS Trial: Angiographic Endpoints at 4-Months (cont.)
Late Loss Rate (mm)
The late loss rate in non-diabetic patients and diabetic patients was 0.14 mm and 0.30 mm respectively. mm
Presented at ACC 2006

8. ZOMAXX-IVUS Trial: Limitations
Randomized data vs an active control comparator will be needed to make an evaluation regarding relative efficacy.
Presented at ACC 2006

9. ZOMAXX-IVUS Trial: Summary
The clinical and angiographic findings in this first in man study of a phosphorylcholine-coated Zotarolimus-eluting stent appear comparable with initial studies of other rapamycin and rapamycin analogs.
Follow-up studies incorporating angiographic follow-up beyond 4 months as well as the results of the randomized ZoMaxx-1 study will provide additional data to expand upon these initial registry findings.
Presented at ACC 2006