Zotarolimus- and Paclitaxel-Eluting Stents in Patients With Coronary Artery Disease - ZoMaxx I

Description:

The goal of the trial was to evaluate percutaneous coronary intervention (PCI) using the ZoMaxx zotarolimus-eluting stent (ZES) compared with the Taxus paclitaxel-eluting stent (PES) among patients with single de novo coronary lesions.

The ZoMaxx stent is a novel platform composed of a tri-layer of stainless-steel and tantalum.

Hypothesis:

Late lumen loss with the ZES will be non-inferior to the PES.

Study Design

  • Randomized
  • Parallel

Patients Enrolled: 396
Mean Follow Up: 9 months
Mean Patient Age: 63 years
Female: 24

Patient Populations:

  • Single de novo coronary lesions with lesion length 10-30 mm and reference vessel diameter 2.5-3.5 mm

Exclusions:

  • Acute MI within 72 hours of procedure
  • Left ventricular ejection fraction
  • Ostial or left main trunk lesions

Primary Endpoints:

  • In-segment late loss at 9 months, evaluated for noninferiority with a 0.25 mm, 95% CI upper bound limit

Secondary Endpoints:

  • Device, lesion, and procedural success
  • MACE
  • Angiographic binary restenosis at 9 months
  • Neointimal hyperplasia volume at 9 months
  • Ischemia-driven target lesion and target vessel revascularization at 9 months

Drug/Procedures Used:

Patients were randomized to PCI with the ZES (n = 199) or the PES (n = 197). Pre-dilatation was required.

Concomitant Medications:

During PCI, patients received heparin and a glycoprotein IIb/IIIa inhibitor according to operator discretion. After PCI, patients received at least 100 mg of aspirin and at least 75 mg of clopidogrel for 6 months.

Principal Findings:

Overall, 396 patients were randomized. The mean age was 63 years and women were 24% of participants. The culprit lesion was in the left anterior descending artery more frequently in the ZES group than the PES group (48% vs. 40%), whereas those in the PES group more frequently had the culprit lesion in the right coronary artery (41% vs. 28%). An ostial lesion was covered in eight patients in the ZES group and no patients in the PES group. Preprocedure reference vessel diameter was 2.8 mm and total stent length was 21 mm in both groups. The mean number of stents used per patient was 1.1. Procedure success was 95% in the ZES group and 96% in the PES group.

The primary endpoint of in-segment late lumen loss did not meet the prespecified non-inferiority margin (0.43 mm for ZES vs. 0.25 mm for PES, mean difference 0.18 mm, upper 95% confidence interval [CI] 0.27 mm, p = NS for non-inferiority; p = 0.003 for superiority of PES). Percent neointimal volume obstruction on intravascular ultrasound was larger in the ZES group (14.6% vs. 11.2%, p = 0.018). There was no difference in major adverse cardiac events (MACE) at 9 months (12.6% for ZES vs. 9.6% for PES, p = 0.43) or components of MACE (cardiac death 0% in each group; Q-wave myocardial infarction [MI] 1.0% vs. 0.5%; non-Q-wave MI 4.5% vs. 4.1%; target vessel revascularization 8.5% vs. 6.6%). There was one stent thrombosis by 30 days in each group. Stent thrombosis did not occur beyond 30 days.

Interpretation:

Among patients with single de novo coronary lesions, PCI with the ZES did not meet the in-segment criteria for non-inferiority compared with the PES at 9-month angiographic follow-up. In fact, the late loss observed with PES was significantly less than ZES. There were no late stent thromboses in either group. Due to chance, more patients in the ZES group, compared with the PES group had an ostial lesion covered.

The present study is the first randomized trial of the ZoMaxx stent. The larger ZoMaxx II trial is currently enrolling patients and has a clinical endpoint rather than an angiographic endpoint. The future of the continued development of the ZoMaxx ZES is unknown, as Abbott, the owner of the stent, recently announced that the company will pursue development of their everolimus-eluting stent system rather than the ZES system.

References:

Chevalier B, Di Mario C, Neumann FJ, et al., on behalf of the ZoMaxx I Investigators. 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. J Am Coll Cardiol Intv 2008;5:524-32.

Presented by Dr. Bernard R. Chevalier at Transcatheter Cardiovascular Therapeutics (TCT 2006) meeting, Washington, DC, October 2006.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Atherosclerotic Disease (CAD/PAD), Interventions and Coronary Artery Disease

Keywords: Coronary Artery Disease, Myocardial Infarction, Follow-Up Studies, Drug-Eluting Stents, Human Rights, Dilatation, Sirolimus, Tantalum, Percutaneous Coronary Intervention, Stents, Paclitaxel, Stainless Steel, Thrombosis, Confidence Intervals


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