Comparison of the Efficacy and Safety of Zotarolimus-Eluting Stent with Sirolimus-Eluting and PacliTaxel-Eluting Stent for Coronary Lesions - ZEST

Sep 27, 2010
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Cardiovascular Research Foundation; Korea Health 21 R&D Project, Ministry of Health and Welfare; and Medtronic Vascular
Date Presented:
01/01/2009
Date Published:
01/01/2010
Date Updated:
09/27/2010
Original Posted Date:
09/27/2010
References

Description:

The goal of the trial was to evaluate zotarolimus-eluting stents compared with paclitaxel- and sirolimus-eluting stents in patients with coronary artery disease.

Hypothesis:

Zotarolimus-eluting stents would reduce major adverse cardiac events.

Study Design

  • Parallel
  • Randomized

Patients Enrolled: 2,640
Mean Follow Up: 12 months
Mean Patient Age: 62 years
Female: 33%

Patient Populations:

  • Patients (all-comers) with coronary artery disease undergoing PCI

Exclusions:

  • Severe left ventricular dysfunction (left ventricular ejection fraction
  • Cardiogenic shock
  • Renal insufficiency
  • Liver dysfunction
  • Left main stenosis
  • In-stent restenosis of a drug-eluting stent
  • Limited life expectancy

Primary Endpoints:

  • Composite of death, myocardial infarction, or ischemia-driven target vessel revascularization at 12 months

Secondary Endpoints:

  • Stent thrombosis
  • Individual components of the primary composite endpoint
  • Late loss

Drug/Procedures Used:

Patients with coronary artery disease were randomized to zotarolimus-eluting stents (n = 883), sirolimus-eluting stents (n = 878), or paclitaxel-eluting stents (n = 884).

Concomitant Medications:

All patients received aspirin and clopidogrel prior to the procedure. Aspirin was administered for life and clopidogrel for at least 12 months. Heparin was routinely used during percutaneous coronary intervention (PCI), and glycoprotein IIb/IIIa inhibitors could be used per operator discretion.

Principal Findings:

Overall, 2,645 patients were randomized. In the zotarolimus group, the mean age was 62 years, 34% were women, 30% had diabetes, 55% presented with an acute coronary syndrome, 9% had prior PCI, and 47% had multivessel disease. Fifty-five percent of the patients had lesions ≥20 mm, 15% had bifurcation lesions, 7% had ostial lesions, and 72% had American College of Cardiology/American Heart Association type B2 or C lesions. The mean number of stents per lesion was 1.2, and the total stent length per lesion was 28 mm. Intravascular ultrasound was used in 41%.

At 12 months, the primary outcome of death, myocardial infarction, or target vessel revascularization had occurred in 10.2% of the zotarolimus group, 8.3% of the sirolimus group, and 14.1% of the paclitaxel group (p = 0.17 for zotarolimus vs. sirolimus, p = 0.01 for zotarolimus vs. paclitaxel).

Death was 0.7%, 0.8%, and 1.1%, myocardial infarction was 5.3%, 6.3%, and 7.0%, target lesion revascularization was 4.9%, 1.4%, and 7.5%, stent thrombosis was 0.5%, 0%, and 0.7%, respectively for zotarolimus, sirolimus, and paclitaxel.

Interpretation:

Among patients with coronary artery disease, including a large proportion of acute coronary syndromes, zotarolimus resulted in similar adverse cardiac events at 12 months compared with sirolimus, and less adverse events compared with paclitaxel.

For individual outcomes, zotarolimus resulted in an intermediate incidence of target lesion revascularization (4.9%); paclitaxel was associated with the highest (7.6%), and sirolimus the lowest (1.4%). Stent thrombosis was less than 1% for all stent types, with no stent thromboses in the sirolimus group.

References:

Park DW, Kim YH, Yun SC, et al. Comparison of zotarolimus-eluting stents with sirolimus- and paclitaxel-eluting stents for coronary revascularization: The ZEST (Comparison of the Efficacy and Safety of Zotarolimus-Eluting Stent with Sirolimus-Eluting and PacliTaxel-Eluting Stent for Coronary Lesions)  randomized trial. J Am Coll Cardiol 2010;56:1187-95.

Comparison of Sirolimus and Paclitaxel-Eluting Stents Versus Zotarolimus-Eluting Stents in Real World Practice: The ZEST Randomized Controlled Trial. Presented by Dr. Seung-Jung Park at ACC.09/i2, Orlando, FL, March 2009.

Keywords: Paclitaxel, Coronary Artery Disease, Myocardial Infarction, Acute Coronary Syndrome, Thrombosis, Drug-Eluting Stents, Sirolimus, Diabetes Mellitus, Stents


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