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The "final" 5-year follow-up from the ENDEAVOR IV trial comparing a zotarolimus-eluting stent with a paclitaxel-eluting stent.

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Kirtane, AJ; Leon, MB; Ball, MW; Bajwa, HS; Sketch, MH; Coleman, PS; Stoler, RC; Papadakos, S; Cutlip, DE; Mauri, L; Kandzari, DE ...
Published in: JACC Cardiovasc Interv
April 2013

OBJECTIVES: This study sought to report the final 5-year outcomes of the ENDEAVOR IV (A Randomized, Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Taxus Paclitaxel-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions) trial comparing the Endeavor zotarolimus-eluting stent (E-ZES) (Medtronic, Santa Rosa, California) with the Taxus paclitaxel-eluting stent (PES) (Boston Scientific, Natick, Massachusetts) in patients with single de novo coronary lesions. BACKGROUND: Primary results of the ENDEAVOR IV trial demonstrated similar clinical outcomes with E-ZES and PES. Concerns with regard to late adverse clinical events with drug-eluting stents highlight the need for long-term follow-up with these devices. METHODS: Late outcomes after the use of E-ZES and PES were examined in the multicenter randomized ENDEAVOR IV trial in cumulative and landmark analyses. Assessed outcomes were related to device efficacy and patient safety. RESULTS: At 5 years, clinical data were available for 722 (93.4%) E-ZES patients and 718 (92.6%) PES patients. Overall rates of target lesion revascularization (7.7% vs. 8.6%, p = 0.70) and target vessel failure were similar (17.2% vs. 21.1%, p = 0.061) with E-ZES compared with PES. The incidence of cardiac death or myocardial infarction (MI) was lower with E-ZES (6.4% vs. 9.1%, p = 0.048), primarily driven by a lower rate of target vessel MI with E-ZES (2.6% vs. 6.0%, p = 0.002). Although overall definite/probable stent thrombosis rates were similar between stents (1.3% vs. 2%, p = 0.42), rates of very late stent thrombosis (0.4% vs. 1.8%, p = 0.012) and late MI events (1.3% vs. 3.5%, p = 0.008) were significantly lower with E-ZES compared with PES. CONCLUSIONS: These data demonstrate the durable efficacy and safety of E-ZES compared with PES for the treatment of de novo coronary lesions. Significant improvements in late safety outcomes were observed with E-ZES but should be considered hypothesis-generating, given the limited statistical power of the trial. (The ENDEAVOR IV Clinical Trial: A Trial of a Coronary Stent System in Coronary Artery Lesions; NCT00217269).

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Published In

JACC Cardiovasc Interv

DOI

EISSN

1876-7605

Publication Date

April 2013

Volume

6

Issue

4

Start / End Page

325 / 333

Location

United States

Related Subject Headings

  • United States
  • Treatment Outcome
  • Time Factors
  • Sirolimus
  • Single-Blind Method
  • Risk Factors
  • Prosthesis Design
  • Prospective Studies
  • Proportional Hazards Models
  • Percutaneous Coronary Intervention
 

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Kirtane, A. J., Leon, M. B., Ball, M. W., Bajwa, H. S., Sketch, M. H., Coleman, P. S., … ENDEAVOR IV Investigators, . (2013). The "final" 5-year follow-up from the ENDEAVOR IV trial comparing a zotarolimus-eluting stent with a paclitaxel-eluting stent. In JACC Cardiovasc Interv (Vol. 6, pp. 325–333). United States. https://doi.org/10.1016/j.jcin.2012.12.123
Kirtane, Ajay J., Martin B. Leon, Michael W. Ball, Harpaul S. Bajwa, Michael H. Sketch, Patrick S. Coleman, Robert C. Stoler, et al. “The "final" 5-year follow-up from the ENDEAVOR IV trial comparing a zotarolimus-eluting stent with a paclitaxel-eluting stent.” In JACC Cardiovasc Interv, 6:325–33, 2013. https://doi.org/10.1016/j.jcin.2012.12.123.
Kirtane AJ, Leon MB, Ball MW, Bajwa HS, Sketch MH, Coleman PS, et al. The "final" 5-year follow-up from the ENDEAVOR IV trial comparing a zotarolimus-eluting stent with a paclitaxel-eluting stent. In: JACC Cardiovasc Interv. 2013. p. 325–33.
Kirtane, Ajay J., et al. “The "final" 5-year follow-up from the ENDEAVOR IV trial comparing a zotarolimus-eluting stent with a paclitaxel-eluting stent.JACC Cardiovasc Interv, vol. 6, no. 4, 2013, pp. 325–33. Pubmed, doi:10.1016/j.jcin.2012.12.123.
Kirtane AJ, Leon MB, Ball MW, Bajwa HS, Sketch MH, Coleman PS, Stoler RC, Papadakos S, Cutlip DE, Mauri L, Kandzari DE, ENDEAVOR IV Investigators. The "final" 5-year follow-up from the ENDEAVOR IV trial comparing a zotarolimus-eluting stent with a paclitaxel-eluting stent. JACC Cardiovasc Interv. 2013. p. 325–333.
Journal cover image

Published In

JACC Cardiovasc Interv

DOI

EISSN

1876-7605

Publication Date

April 2013

Volume

6

Issue

4

Start / End Page

325 / 333

Location

United States

Related Subject Headings

  • United States
  • Treatment Outcome
  • Time Factors
  • Sirolimus
  • Single-Blind Method
  • Risk Factors
  • Prosthesis Design
  • Prospective Studies
  • Proportional Hazards Models
  • Percutaneous Coronary Intervention