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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. ZOMAXX-IVUS Trial: Background.
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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
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
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
ZOMAXX IVUS Trial: Primary Endpoint Reduction in Diameter Stenosis (%) Acute Gains (mm) 1.86±0.34 mm 19±7% 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
ZOMAXX IVUS Trial: Angiographic Endpoints at 4-Months Reduction in Diameter Stenosis (%) n=37 Late Loss (mm) n=37 0.20±0.35 mm 0.17±0.35 mm 23.0±13% % 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
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
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
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
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