Comparative efficacy of 2 zotarolimus-eluting stent generations: resolute versus endeavor stents in patients with coronary artery disease.

Abstract

BACKGROUND:

The Resolute zotarolimus-eluting stent (R-ZES) utilizes the same metallic platform and anti-restenotic drug as the Endeavor zotarolimus-eluting stent (E-ZES) but is coated with a more biocompatible polymer with enhanced drug-release kinetics. The aim of this study was to compare the long-term clinical outcomes of 2 zotarolimus-eluting stent generations.

METHODS:

In two randomized trials with broad inclusion criteria (ISAR-TEST 2 and ISAR-TEST 5), 1,000 patients were treated with R-ZES and 339 patients treated with E-ZES. In both trials follow-up angiography was scheduled at 6 to 8 months. The efficacy endpoint of interest was target lesion revascularization and the safety endpoints were the combined incidence of cardiac death or myocardial infarction related to target vessel as well as the incidence of definite stent thrombosis at 2-year follow-up.

RESULTS:

The incidence of target lesion revascularization at 2 years was 12.0% in the R-ZES group and 16.0% in the E-ZES (HR 0.72 [95% CI: 0.52-1.00], P = .052). The incidence of cardiac death or myocardial infarction was 5.5% vs. 4.8% (HR 1.15, [95% CI: 0.66-2.02], P = .62) and of definite stent thrombosis was 0.4% vs. 0.6% (HR 0.68, [95% CI: 0.12-3.72], P = .66), respectively. All measures of angiographic restenosis were in favor of the R-ZES; in-stent late lumen loss was 0.29 ± 0.56 with the R-ZES versus 0.58 ± 0.55 with the E-ZES (P < .0001).

CONCLUSIONS:

Comparison of the 2 Food and Drug Administration-approved zotarolimus-eluting stents suggested that the R-ZES as compared to the E-ZES displayed overall superior antirestenotic efficacy. Both devices were associated with a similar low risk of adverse safety events through 2 years.

• Authors: Tomohisa Tada, Robert A Byrne, Salvatore Cassese, Lamin King, Stefanie Schulz, Julinda Mehilli, Albert Schömig, Adnan Kastrati
• Journal: American heart journal (Am Heart J) Vol. 165 Issue 1 Pg. 80-6 (Jan 2013) ISSN: 1097-6744 [Electronic] United States
• PMID: 23237137 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial)
• Copyright: Copyright © 2013 Mosby, Inc. All rights reserved.

Chemical References

• zotarolimus
• Sirolimus

Topics

• Aged
• Coronary Angiography
• Coronary Artery Disease (diagnostic imaging, drug therapy, therapy)
• Death
• Drug-Eluting Stents
• Female
• Follow-Up Studies
• Humans
• Male
• Myocardial Infarction (epidemiology, prevention & control)
• Prosthesis Design
• Risk Assessment
• Sirolimus (analogs & derivatives, therapeutic use)
• Thrombosis (epidemiology, prevention & control)
• Treatment Outcome