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Interventional cardiology
Twelve-month outcomes in patients with diabetes implanted with a zotarolimus-eluting stent: results from the E-Five Registry
  1. Ajay K Jain1,
  2. Chaim Lotan2,
  3. Ian T Meredith3,
  4. Faustos Feres4,
  5. Robaayah Zambahari5,
  6. Nakul Sinha6,
  7. Martin T Rothman1,
  8. for the E-Five Registry Investigators7
  1. 1Barts and The London National Health Service Trust, London, UK
  2. 2Heart Institute, Hadassah-Hebrew University Medical Centre, Jerusalem, Israel
  3. 3MonashHeart Monash Medical Centre, Monash University, Melbourne, Australia
  4. 4Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil
  5. 5National Heart Institute, Kuala Lumpur, Malaysia
  6. 6SGPGI Lucknow, Lucknow, India
  7. 7A complete list of the E-Five Investigators is provided in the appendix
  1. Correspondence to Professor Martin T Rothman, Department of Cardiology, London Chest Hospital, London E2 9JX, UK; rothcons{at}dircon.co.uk

Abstract

Objective To retrospectively evaluate the 12-month effectiveness of the Endeavor zotarolimus-eluting stent (ZES) in diabetic versus non-diabetic patients enrolled in the E-Five Registry.

Design and Setting The E-Five Registry is a prospective, multicentre registry of 8314 patients presenting with symptomatic coronary artery disease treated with the Endeavor (ZES). Patients were treated at 188 centres located in 37 countries across Europe, Latin America and Asia Pacific.

Patients There were 2721 (32.7%) patients with diabetes (DM) and among these patients 682 were insulin-treated (ITDM) and 2039 were non-insulin-treated diabetic patients (NITDM).

Interventions All enrolled patients received an Endeavor ZES and were followed for 12 months.

Main outcome measurements The primary outcome measure was major adverse cardiac event (MACE) at 12 months. Secondary endpoints included target lesion revascularisation (TLR), target vessel revascularisation (TVR), target vessel failure (TVF) and stent thrombosis.

Results Compared with non-DM patients, DM patients had higher rates of MACE (9.7% vs 6.4%, p<0.001), TLR (5.3% vs 4.0%, p=0.028) and Academic Research Consortium (ARC) definite and probable stent thrombosis (1.5% vs 0.9%, p=0.041). Compared with non-DM patients, ITDM patients had higher rates of MACE (12.6% vs 6.4%, p<0.001). ITDM patients had higher rates of death (6.7% vs 1.7%, p<0.001), cardiac death (4.5% vs 1.2%, p<0.001) and TLR (6.5% vs 4.0%, p=0.011) than non-DM patients.

Conclusions The Endeavor ZES performed well in DM patients; however, DM patients experienced higher rates of adverse clinical events compared with non-DM patients.

Trial Reg No Clinical trial registration information: http://www.clinicaltrials.gov; Unique identifier: NTC00623441

  • Endeavor
  • zotarolimus
  • global registry
  • diabetes
  • major adverse cardiac event
  • drug-eluting stent
  • coronary stenting
  • coronary artery disease (CAD)

This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.

https://doi.org/10.1136/hrt.2009.184150

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    Footnotes

    • Funding This Registry is funded by the Medtronic Bakken Research Center, Medtronic CardioVascular, Inc.

    • Competing interests AKJ, CL, ITM and MTR have served as consultants to Medtronic, Inc. MTR has received research/grant support from Medtronic, Inc and since this paper was written has become VP Medical Affairs, Coronary & Peripheral Division, Medtronic, Inc. JM is a stockholder and employee of Medtronic, Inc. CL has served as a consultant for Angio Score Ltd. ITM has served as an advisory board member for Boston Scientific; MTR has served as a consultant to Abbott Vascular, Cordis Corporation, JenaValve Technology, GmbH, Lombard Medical Technologies plc and Volcano and has received research/grant support from Abbott Vascular, Boston Scientific, CardioBridge GmbH, and Cordis Corporation.

    • Patient consent Obtained.

    • Ethics approval This study was conducted with the approval of the local ethics committees from the 188 centres participating in this Registry.

    • Provenance and peer review Not commissioned; externally peer reviewed.