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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Yonsei University
Sponsor:
Collaborator:
Gangwon Cardiovascular Health Research Institute
Information provided by (Responsible Party):
Yoon Junghan, Yonsei University
ClinicalTrials.gov Identifier:
NCT01397175
First received: July 5, 2011
Last updated: September 23, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Device: Biolimus-eluting stent
Device: Everolimus-eluting stent
Device: Zotarolimus-eluting stent
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-labeled, Randomized Controlled Trial Comparing Three 2nd Generation Drug-Eluting Stents in Real-World Practice

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Device-oriented composite [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: at 24 months ] [ Designated as safety issue: Yes ]
    Patient-oriented composite consisted of all-cause mortality, any myocardial infarction, and any revascularization at 24-month clinical follow-up

  • Device-oriented composite [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Device-oriented composite at 12-month clinical follow-up

  • Patient-oriented composite [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Patient-oriented composite at 12-month clinical follow-up

  • Each component of device- and patient-oriented composite [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Each component of device- and patient-oriented composite at 12 months

  • Each component of device- and patient-oriented composite [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Each component of device- and patient-oriented composite at 24 months

  • ARC defined stent thrombosis [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    ARC defined stent thrombosis at 12 months

  • ARC defined stent thrombosis [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    ARC defined stent thrombosis at 24 months

  • Stent thrombosis [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    ARC defined stent thrombosis at 12 months after randomization

  • Stent thrombosis [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    ARC defined stent thrombosis at 24 months after randomization

  • Bleeding complications defined by BARC definition [ Time Frame: before discharge ] [ Designated as safety issue: Yes ]
    Bleeding complications defined by BARC definition before discharge


Estimated Enrollment: 2580
Study Start Date: January 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01397175

Contacts
Contact: Junghan Yoon, M.D., Ph.D. 82-33-741-0906 jyoon@yonsei.ac.kr
Contact: Young Jin Youn, M.D. 82-33-741-1216 younyj@yonsei.ac.kr

Locations
Korea, Republic of
Wonju Christian Hospital Recruiting
Wonju, Gangwon, Korea, Republic of, 220-701
Contact: Junghan Yoon, M.D., Ph.D.    82-33-741-0906    jyoon@yonsei.ac.kr   
Contact: Young Jin Youn, M.D.    82-33-741-1216    younyj@yonsei.ac.kr   
Chonnam National University Hospital Recruiting
Chuncheon, Korea, Republic of
Contact: Myung Ho Jeong, MD, PhD       myungho@chollian.net   
Daegu Catholic University Hospital Recruiting
Daegu, Korea, Republic of
Contact: Jin-Bae Lee, MD, PhD       jblee@cu.ac.kr   
Inha University Hospital Recruiting
Incheon, Korea, Republic of
Contact: Keum Soo Park, MD, PhD       kspark@inha.ac.kr   
Suncheon St. Carollo Hospital Recruiting
Suncheon, Korea, Republic of
Contact: Jang Hyun Cho, MD, PhD       goodnew8@naver.com   
Sponsors and Collaborators
Yonsei University
Gangwon Cardiovascular Health Research Institute
Investigators
Principal Investigator: Junghan Yoon, M.D., Ph.D. Wonju Chrisitian Hospital
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yoon Junghan, Professor of Cardiology, Department of Internal Medicine, Yonsei University
ClinicalTrials.gov Identifier: NCT01397175     History of Changes
Other Study ID Numbers: CHOICE
Study First Received: July 5, 2011
Last Updated: September 23, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Yonsei University:
Coronary artery disease
Percutaneous coronary intervention
Drug-eluting stent

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents

ClinicalTrials.gov processed this record on August 25, 2014