ZOMAXX-IVUS Trial
Percutaneous Coronary Revascularization Using a
Trilayer Phosphorylcholine-coated Zotarolimuseluting Stent (ZoMaxx IVUS) Trial
Presented at
The American College of Cardiology
Scientific Session 2006
Presented by Dr. A. Abazid
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.
www. Clinical trial results.org
Presented at ACC 2006
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
www. Clinical trial results.org
Presented at ACC 2006
ZOMAXX IVUS Trial: Primary Endpoint
Reduction in Diameter Stenosis (%)
Acute Gains (mm)
1.86±0.34 mm
19±7%
2.00
25
1.48±0.38 mm
20
1.50
mm
5.1±5.3%
%
15
1.00
10
5
0.50
0
-5
0.00
In-Stent
In-Segment
In-Stent
In-Segment
• 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).
www. Clinical trial results.org
Presented at ACC 2006
ZOMAXX IVUS Trial: Angiographic Endpoints at
4-Months
Reduction in Diameter Stenosis (%)
n=37
30
25
23.0±13%
0.6
0.20±0.35 mm
0.17±0.35 mm
0.5
0.4
mm
%
40
35
Late Loss (mm)
n=37
10.0±14%
0.3
20
15
0.2
10
5
0.0
0.1
-0.1
0
-5
-0.2
In-Stent
In-Segment
In-Stent
In-Segment
• 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.
www. Clinical trial results.org
Presented at ACC 2006
ZOMAXX-IVUS Trial: Angiographic Endpoints at 4Months (cont.)
• There were no lesion, procedure, and devicedeployment failures.
• One patient had a diameter stenosis of 55%.
• The binary restenosis rate was 5.4%.
• There was no evidence of angiographic edge
restenosis.
www. Clinical trial results.org
Presented at ACC 2006
ZOMAXX IVUS Trial: Angiographic Endpoints at 4-Months
(cont.)
Late Loss Rate (mm)
0.40
0.30
mm
0.30
0.20
• The late loss rate in
non-diabetic patients
and diabetic patients
was 0.14 mm and 0.30
mm respectively.
0.14
0.10
0.00
Non-Diabetic
Patients
www. Clinical trial results.org
Diabetic
Patients
Presented at ACC 2006
ZOMAXX-IVUS Trial: Limitations
• Randomized data vs an active control comparator
will be needed to make an evaluation regarding
relative efficacy.
www. Clinical trial results.org
Presented at ACC 2006
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.
www. Clinical trial results.org
Presented at ACC 2006