A Randomized, Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of Zotarolimus- Versus Paclitaxel-Eluting Stents in De Novo Occlusive Lesions in Coronary ArteriesThe ZoMaxx I Trial
Bernard Chevalier, MD*,
Carlo Di Mario, MD ,
Franz-Josef Neumann, MD ,
Flavio Ribichini, MD ,
Philip Urban, MD||,
Jeffrey J. Popma, MD¶,
Peter J. Fitzgerald, MD, PhD#,
Donald E. Cutlip, MD**,
David O. Williams, MD,
John Ormiston, MD,
Eberhard Grube, MD,
Robert Whitbourn, MD||||,
Lewis B. Schwartz, MD¶¶,* for the ZoMaxx I Investigators
* Centre Cardiologique du Nord; Saint-Denis, France
Royal Brompton Hospital; London, England
Herz-Zentrum Bad Krozingen; Bad Krozingen, Germany
Università del Piemonte Orientale; Novara, Italy
|| La Tour Hospital; Geneva, Switzerland
¶ Brigham & Women's Hospital; Boston, Massachusetts
# Stanford University Medical Center; Palo Alto, California
** Harvard Clinical Research Institute; Boston, Massachusetts
Rhode Island Hospital; Providence, Rhode Island
Auckland City Hospital; Auckland, New Zealand
Heart Center Siegburg; Siegburg, Germany
|||| St. Vincent's Hospital; Melbourne, Australia
¶¶ Abbott Laboratories; Abbott Park, Illinois
* Reprint requests and correspondence: Dr. Lewis B. Schwartz, Abbott Laboratories, 200 Abbott Park Road, AP52-2, Abbott Park, Illinois 60064-6215 (Email: lewis.schwartz{at}abbott.com).
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.
Background: The ZoMaxx stent system elutes 10 µg/mm zotarolimus using a phosphorylcholine polymer loaded onto a novel stainless steel stent platform containing a 0.0007-inch inner layer of tantalum.
Methods: Twenty-nine investigative sites in Europe, Australia, and New Zealand enrolled 401 patients, 396 of whom received a study stent.
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).
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.
Key Words: drug-eluting stent • stent • zotarolimus • restenosis • coronary artery disease
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Abbreviations and Acronyms
| | CK = creatine kinase | | DES = drug-eluting stents | | IVUS = intravascular ultrasound | | MACE = major adverse cardiovascular events | | MLD = minimum lumen diameter | | PC = phosphorylcholine | | TLR = target lesion revascularization | | TVR = target vessel revascularization |
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D. R. Holmes Jr and M. Patel
The Process of Bringing New Drug-Eluting Stents to Market: Will They See the Light of Day?
J. Am. Coll. Cardiol. Intv.,
October 1, 2008;
1(5):
533 - 534.
[Full Text]
[PDF]
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