BES, EES, and ZES-R in Real World Practice (CHOICE)

July 5, 2019 updated by: Yoon Junghan, Yonsei University

A Multicenter, Open-labeled, Randomized Controlled Trial Comparing Three 2nd Generation Drug-Eluting Stents in Real-World Practice

The primary objective of this study is to compare the rate of device-oriented composite consisted of cardiac death, myocardial infarction not clearly attributable to a nontarget vessel, and clinically indicated target lesion revascularization among the patients treated with EES, ZES-R, or BES at 24-month clinical follow-up post-index procedure. Trial end points are summarized in Table I. The hypothesis is that BES is equivalent to EES or BES is equivalent to ZES-R at the primary end point.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Previous randomized trials have shown the superior efficacy of drug-eluting stents (DES), such as sirolimus-eluting stent (SES, CYPHER, Cordis, US), paclitaxel-eluting stent (PES, TAXUS, Boston Scientific, US), and zotarolimus-eluting stent (ZES, Endeavor, Medtronic, US) compared with bare metal stents (BMS) by reducing neointimal hyperplasia, late luminal loss, and angiographic restenosis leading to decreased target lesion revascularization. Unfortunately, restenosis still occurs and late stent thrombosis can develop by delaying endoluminal healing or by chronic inflammation.Accordingly, development of new DES is required to improve efficacy by reducing revascularization and safety by reducing the risk of stent thrombosis. With the improvement of polymer, drug, and the platform, the 2nd generation DES, including everolimus-eluting stent (EES, Xience V or Xience Prime, Abbott, USA), zotarolimus-eluting stent with biolinx polymer (ZES-R, Endeavor Resolute or Endeavor Resolute Integrity, Medtronic, USA), and biolimus-eluting stent (BES, BioMatrix or Biomatrix Flex, Biosensors, USA), have been shown to be superior or non-inferior in safety and efficacy trials compared with 1st generation DES.

However, it is difficult to know if there are any differences in efficacy and safety between the EES, the ZES-R, and the BES, in real world practice due to the lack of data comparing these three 2nd generation DES directly. This study provides the evidence for the CHOICE of stent when physicians are treating patients by percutaneous coronary intervention.

Study Type

Interventional

Enrollment (Actual)

1960

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Chuncheon, Korea, Republic of
        • Chonnam National University Hospital
      • Daegu, Korea, Republic of
        • Daegu Catholic University Hospital
      • Incheon, Korea, Republic of
        • Inha University Hospital
      • Suncheon, Korea, Republic of
        • Suncheon St. Carollo Hospital
    • Gangwon
      • Wonju, Gangwon, Korea, Republic of, 220-701
        • Wonju Christian Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Age > 19 years
  • Subject is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the drug-eluting stent(s) and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure
  • Subject must have significant stenosis (>50% by visual estimate) on a native or in-stent coronary artery
  • Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, recent infarction, acute myocardial infarction, positive functional study or a reversible changes in the ECG consistent with ischemia). In subjects with coronary artery stenosis >75%, evidence of myocardial ischemia does not have to be documented

Exclusion Criteria

  • Subject has a known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, prasugrel, ticagrelor, biolimus A9, everolimus, zotarolimus, stainless steel, cobalt chromium, contrast media (Patients with documented sensitivity to contrast media, which can be effectively premedicated with steroid and diphenhydramine may be enrolled. However, those with true anaphylaxis to prior contrast media should not be enrolled.)
  • Subject in use of systemic (intravenous) biolimus A9, everolimus or zotarolimus within 12 months.
  • Female subject of childbearing potential, unless a recent pregnancy test is negative, who possibly plans to become pregnant any time after enrollment into this study
  • Subject planned an elective surgical procedure that would necessitate interruption of antiplatelet during the first 12 months post enrollment
  • Subject with non-cardiac co-morbid condition with life expectancy < 2 year or that may result in protocol non-compliance (per site investigator's medical judgment)
  • Subject with cardiogenic shock at presentation
  • Subject who are actively participating in another drug or device investigational study, who have not completed the primary end point follow-up period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Biolimus-eluting stent
Biomatrix stent, Biosensors, USA Biomatrix Flex stent, Biosensors, USA
Device: Biolimus-eluting stent
Biolimus-eluting stent (BES, BioMatrix or BioMatrix Flex, Biosensors, USA) has bio-degradable polymer which is consisted with poly-lactic acid (PLA) and degraded into H2O and CO2 while releasing the biolimus. BES would be expected to reduce the stent thrombosis comparing with the DES with durable polymer.
Other Names:
  • Biomatrix, Biosensors, USA
  • Biomatrix flex, Biosensors, USA
Active Comparator: Everolimus-eluting stent
Xience Prime stent, Abbott, USA Xience V stent, Abbott, USA
Device: Everolimus-eluting stent
Everolimus-eluting stent (EES, Xience V or Xience Prime, Abbott, USA) use the MULTILINK VISION stent platform and durable polymer containing everolimus. It has the thinnest strut thickness among the available DES in Korea.
Other Names:
  • Xience V, Abbott, USA
  • Xience Prime, Abbott, USA
Active Comparator: Zotarolimus-eluting stent
Endeavor resolute, Medtronic, USA Endeavor resolute integrity, Medtronic, USA
Device: Zotarolimus-eluting stent
Zotarolimus-eluting stent with biolinx polymer (ZES, Endeavor Resolute or Endeavor Resolute Intergrity, Medtronic, USA) has DRIVER stent platform. The durable polymer in this DES has changed from phosphorylcholine (PC) polymer which was used in Endeavor to Biolinx polymer which has more biocompatible features.
Other Names:
  • Endeavor Resolute, Medtronic, USA
  • Endeavor Resolute Integrity, Medtronic, USA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device-oriented composite
Time Frame: 24 months
Device-oriented composite consisted of cardiac death, myocardial infarction not clearly attributable to a nontarget vessel, and clinically indicated target lesion revascularization (TLR) at 24-month clinical follow-up
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-oriented composite
Time Frame: at 24 months
Patient-oriented composite consisted of all-cause mortality, any myocardial infarction, and any revascularization at 24-month clinical follow-up
at 24 months
Device-oriented composite
Time Frame: 12 months
Device-oriented composite at 12-month clinical follow-up
12 months
Patient-oriented composite
Time Frame: 12 months
Patient-oriented composite at 12-month clinical follow-up
12 months
Each component of device- and patient-oriented composite
Time Frame: 12 months
Each component of device- and patient-oriented composite at 12 months
12 months
Each component of device- and patient-oriented composite
Time Frame: 24 months
Each component of device- and patient-oriented composite at 24 months
24 months
ARC defined stent thrombosis
Time Frame: 12 months
ARC defined stent thrombosis at 12 months
12 months
ARC defined stent thrombosis
Time Frame: 24 months
ARC defined stent thrombosis at 24 months
24 months
Stent thrombosis
Time Frame: 12 months
ARC defined stent thrombosis at 12 months after randomization
12 months
Stent thrombosis
Time Frame: 24 months
ARC defined stent thrombosis at 24 months after randomization
24 months
Bleeding complications defined by BARC definition
Time Frame: before discharge
Bleeding complications defined by BARC definition before discharge
before discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Collaborators

Gangwon Cardiovascular Health Research Institute

Investigators

  • Principal Investigator: Junghan Yoon, M.D., Ph.D., Wonju Chrisitian Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2013

Primary Completion (Actual)

December 5, 2017

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

July 5, 2011

First Submitted That Met QC Criteria

July 18, 2011

First Posted (Estimate)

July 19, 2011

Study Record Updates

Last Update Posted (Actual)

July 9, 2019

Last Update Submitted That Met QC Criteria

July 5, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHOICE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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