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

Primary Purpose

Coronary Artery Disease

Status
Terminated
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Biolimus-eluting stent
Everolimus-eluting stent
Zotarolimus-eluting stent
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary artery disease, Percutaneous coronary intervention, Drug-eluting stent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wonju Christian Hospital
  • Chonnam National University Hospital
  • Daegu Catholic University Hospital
  • Inha University Hospital
  • Suncheon St. Carollo Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Biolimus-eluting stent

Everolimus-eluting stent

Zotarolimus-eluting stent

Arm Description

Biomatrix stent, Biosensors, USA Biomatrix Flex stent, Biosensors, USA

Xience Prime stent, Abbott, USA Xience V stent, Abbott, USA

Endeavor resolute, Medtronic, USA Endeavor resolute integrity, Medtronic, USA

Outcomes

Primary Outcome Measures

Device-oriented composite
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

Secondary Outcome Measures

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

Full Information

First Posted
July 5, 2011
Last Updated
July 5, 2019
Sponsor
Yonsei University
Collaborators
Gangwon Cardiovascular Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01397175
Brief Title
BES, EES, and ZES-R in Real World Practice
Acronym
CHOICE
Official Title
A Multicenter, Open-labeled, Randomized Controlled Trial Comparing Three 2nd Generation Drug-Eluting Stents in Real-World Practice
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment
Study Start Date
January 16, 2013 (Actual)
Primary Completion Date
December 5, 2017 (Actual)
Study Completion Date
January 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yonsei University
Collaborators
Gangwon Cardiovascular Health Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary artery disease, Percutaneous coronary intervention, Drug-eluting stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
BES EES ZES-R
Masking
Participant
Allocation
Randomized
Enrollment
1960 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biolimus-eluting stent
Arm Type
Active Comparator
Arm Description
Biomatrix stent, Biosensors, USA Biomatrix Flex stent, Biosensors, USA
Arm Title
Everolimus-eluting stent
Arm Type
Active Comparator
Arm Description
Xience Prime stent, Abbott, USA Xience V stent, Abbott, USA
Arm Title
Zotarolimus-eluting stent
Arm Type
Active Comparator
Arm Description
Endeavor resolute, Medtronic, USA Endeavor resolute integrity, Medtronic, USA
Intervention Type
Device
Intervention Name(s)
Biolimus-eluting stent
Other Intervention Name(s)
Biomatrix, Biosensors, USA, Biomatrix flex, Biosensors, USA
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Everolimus-eluting stent
Other Intervention Name(s)
Xience V, Abbott, USA, Xience Prime, Abbott, USA
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Zotarolimus-eluting stent
Other Intervention Name(s)
Endeavor Resolute, Medtronic, USA, Endeavor Resolute Integrity, Medtronic, USA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Device-oriented composite
Description
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
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Patient-oriented composite
Description
Patient-oriented composite consisted of all-cause mortality, any myocardial infarction, and any revascularization at 24-month clinical follow-up
Time Frame
at 24 months
Title
Device-oriented composite
Description
Device-oriented composite at 12-month clinical follow-up
Time Frame
12 months
Title
Patient-oriented composite
Description
Patient-oriented composite at 12-month clinical follow-up
Time Frame
12 months
Title
Each component of device- and patient-oriented composite
Description
Each component of device- and patient-oriented composite at 12 months
Time Frame
12 months
Title
Each component of device- and patient-oriented composite
Description
Each component of device- and patient-oriented composite at 24 months
Time Frame
24 months
Title
ARC defined stent thrombosis
Description
ARC defined stent thrombosis at 12 months
Time Frame
12 months
Title
ARC defined stent thrombosis
Description
ARC defined stent thrombosis at 24 months
Time Frame
24 months
Title
Stent thrombosis
Description
ARC defined stent thrombosis at 12 months after randomization
Time Frame
12 months
Title
Stent thrombosis
Description
ARC defined stent thrombosis at 24 months after randomization
Time Frame
24 months
Title
Bleeding complications defined by BARC definition
Description
Bleeding complications defined by BARC definition before discharge
Time Frame
before discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junghan Yoon, M.D., Ph.D.
Organizational Affiliation
Wonju Chrisitian Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wonju Christian Hospital
City
Wonju
State/Province
Gangwon
ZIP/Postal Code
220-701
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Chuncheon
Country
Korea, Republic of
Facility Name
Daegu Catholic University Hospital
City
Daegu
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Incheon
Country
Korea, Republic of
Facility Name
Suncheon St. Carollo Hospital
City
Suncheon
Country
Korea, Republic of

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BES, EES, and ZES-R in Real World Practice

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