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

July 5, 2011
September 23, 2013
January 2013
June 2016   (final data collection date for primary outcome measure)
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
Target-lesion failure [ Time Frame: within first 12 months ] [ Designated as safety issue: Yes ]
The primary end point is target-lesion failure, defined as a composite of death from cardiac causes, any myocardial infarction (not clearly attributable to a non-target vessel), or clinically indicated target-lesion revascularization at 12 months.
Complete list of historical versions of study NCT01397175 on ClinicalTrials.gov Archive Site
  • 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
  • Target vessel failure [ Time Frame: at 24 months ] [ Designated as safety issue: Yes ]
    Composite of death from any cause, any myocardial infarction (Q-wave or non-Q-wave), or any revascularization (either a percutaneous or surgical procedure with either a clinical or nonclinical indication)
  • Death [ Time Frame: at 24 months ] [ Designated as safety issue: Yes ]
    death from any cause
  • Myocardial infarction [ Time Frame: at 24 months ] [ Designated as safety issue: Yes ]
    any myocardial infarction (Q-wave or non-Q-wave)
  • Revascularization [ Time Frame: at 24 months ] [ Designated as safety issue: Yes ]
    any revascularization (either a percutaneous or surgical procedure with either a clinical or nonclinical indication)
  • Stent thrombosis [ Time Frame: at 24 months ] [ Designated as safety issue: Yes ]
    definite, probable, possible, and overall stent thrombosis, defined according to the Academic Research Consortium definition
  • Quantitative angiographic end points [ Time Frame: at 25 months ] [ Designated as safety issue: No ]
    Quantitative angiographic end points included in-stent and in-segment percent stenosis, rate of binary restenosis, minimal lumen diameter, and late lumen loss
Not Provided
Not Provided
 
BES, EES, and ZES-R in Real World Practice
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Coronary Artery Disease
  • 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
  • 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
  • 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
  • Active Comparator: Biolimus-eluting stent
    Biomatrix stent, Biosensors, USA Biomatrix Flex stent, Biosensors, USA
    Intervention: Device: Biolimus-eluting stent
  • Active Comparator: Everolimus-eluting stent
    Xience Prime stent, Abbott, USA Xience V stent, Abbott, USA
    Intervention: Device: Everolimus-eluting stent
  • Active Comparator: Zotarolimus-eluting stent
    Endeavor resolute, Medtronic, USA Endeavor resolute integrity, Medtronic, USA
    Intervention: Device: Zotarolimus-eluting stent

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2580
June 2016
June 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
Korea, Republic of
 
NCT01397175
CHOICE
Yes
Yoon Junghan, Yonsei University
Yonsei University
Gangwon Cardiovascular Health Research Institute
Principal Investigator: Junghan Yoon, M.D., Ph.D. Wonju Chrisitian Hospital
Yonsei University
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP