ZOMAXX-IVUS Study - Percutaneous Coronary Revascularization Using A Trilayer Phosphorylcholine-coated Zotarolimus-eluting Stent: The ZoMaxx IVUS Trial

Mar 12, 2006
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Date Presented:
01/01/2006
Date Updated:
03/12/2006
Original Posted Date:
03/12/2006
References

Description:

Report of findings of the Percutaneous Coronary Revascularization Using A Trilayer Phosphorylcholine-coated

Hypothesis:

Percutaneous Coronary Revascularization Using the Zotarolimus-eluting Stent would be associated with low rates of angiographic restenosis

Study Design

Study Design:

Patients Enrolled: 40
Mean Follow Up: 4 months
Mean Patient Age: Mean age 59 years
Female: 45

Patient Populations:

Symptomatic ischemic coronary occlusive disease due to single de novo obstructive lesions

Primary Endpoints:

Percent in-stent net volume obstruction at 4 months

Secondary Endpoints:

Individual and combined endpoints including death, myocardial infarction, ischemia driven revascularization

Drug/Procedures Used:

Patients enrolled in the registry underwent percutaneous coronary intervention (PCI) using the 3.5 mm x 18 mm Zomaxx stent.

Principal Findings:

There were no lesion, procedure, and device-deployment failures. Post-procedure, in-stent and in-segment diameter stenoses had been reduced to 5.1±5.3% and 19±7%, respectively, with in-stent and in-segment acute gains of 1.86±0.34 mm and 1.48±0.38 mm. There were no major adverse cardiac events during the study (MACE: composite endpoint of non-Q wave MI, Q-wave MI, ischemia target vessel revascularization and cardiac death).

At 4 month angiographic follow-up (n=37), in-stent diameter stenosis (DS) was 10.0% +/-14%. Late loss was 0.20 +/- 0.35 mm. DS of 55% was noted in 1 patient. In-segment late loss was 0.17 +/- 0.35 mm and diameter stenosis was 23% +/- 13 %. The binary restenosis rate was 5.4%. There was no evidence of angiographic edge restenosis. The late loss rate in non-diabetic patients was 0.14 mm and 0.30 mm in diabetic patients.

Interpretation:

These first in man data demonstrate clinical and angiographic findings using the Phosphorylcholine-coated Zotarolimus-eluting Stent that appear comparable with initial studies of other rapamycin and rapamycin analogs, although randomized data would be needed to make an evaluation on efficacy. 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 registry findings.

References:

Presented by Dr. A. Abazid at the March 2006 i2 Summit Annual Scientific Session, Atlanta, GA.

Keywords: Follow-Up Studies, Coronary Restenosis, Constriction, Pathologic, Sirolimus, Phosphorylcholine, Diabetes Mellitus, Stents, Percutaneous Coronary Intervention


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