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A randomized, controlled, multicenter trial to evaluate the safety and efficacy of zotarolimus- versus paclitaxel-eluting stents in de novo occlusive lesions in coronary arteries The ZoMaxx I trial.
- Source :
-
JACC. Cardiovascular interventions [JACC Cardiovasc Interv] 2008 Oct; Vol. 1 (5), pp. 524-32. - Publication Year :
- 2008
-
Abstract
- Objectives: A novel zotarolimus-eluting coronary stent system (ZoMaxx, Abbott Laboratories, Abbott Park, Illinois) was compared with a paclitaxel-eluting coronary stent (Taxus Express2) in a randomized trial of percutaneous intervention for de novo coronary artery stenosis. The primary end point was defined as noninferiority of in-segment late lumen loss after 9 months.<br />Background: The ZoMaxx stent system elutes 10 microg/mm zotarolimus using a phosphorylcholine polymer loaded onto a novel stainless steel stent platform containing a 0.0007-inch inner layer of tantalum.<br />Methods: Twenty-nine investigative sites in Europe, Australia, and New Zealand enrolled 401 patients, 396 of whom received a study stent.<br />Results: After 9 months, late lumen loss was significantly greater in the ZoMaxx group (in-stent 0.67 +/- 0.57 mm vs. 0.45 +/- 0.48 mm; p < 0.001; in-segment 0.43 +/- 0.60 mm vs. 0.25 +/- 0. 45 mm; p = 0.003), resulting in significantly higher rates of >50% angiographic restenosis (in-stent 12.9% vs. 5.7%; p = 0.03; in-segment 16.5% vs. 6.9%; p = 0.007). The upper bound of the 95% confidence interval on the difference in in-segment late lumen loss between the 2 treatment groups (0.27 mm) exceeded the 0.25 mm value pre-specified for noninferiority. There were no significant differences between ZoMaxx and Taxus-treated groups with respect to target lesion revascularization (8.0% vs. 4.1%; p = 0.14), major adverse cardiac events (12.6% vs. 9.6%; p = 0.43), or stent thrombosis (0.5% in both groups).<br />Conclusions: After 9 months, the ZoMaxx stent showed less neointimal inhibition than the Taxus stent, as shown by higher in-stent late loss and restenosis by qualitative coronary angiography.
- Subjects :
- Aged
Angioplasty, Balloon, Coronary adverse effects
Australia
Coronary Angiography
Coronary Restenosis etiology
Coronary Restenosis pathology
Coronary Stenosis pathology
Europe
Female
Humans
Logistic Models
Male
Middle Aged
New Zealand
Prospective Studies
Prosthesis Design
Risk Assessment
Severity of Illness Index
Sirolimus administration & dosage
Thrombosis etiology
Thrombosis pathology
Time Factors
Treatment Outcome
Ultrasonography, Interventional
Angioplasty, Balloon, Coronary instrumentation
Cardiovascular Agents administration & dosage
Coronary Restenosis prevention & control
Coronary Stenosis therapy
Drug-Eluting Stents
Paclitaxel administration & dosage
Sirolimus analogs & derivatives
Thrombosis prevention & control
Subjects
Details
- Language :
- English
- ISSN :
- 1876-7605
- Volume :
- 1
- Issue :
- 5
- Database :
- MEDLINE
- Journal :
- JACC. Cardiovascular interventions
- Publication Type :
- Academic Journal
- Accession number :
- 19463354
- Full Text :
- https://doi.org/10.1016/j.jcin.2008.08.010