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

NCT01397175 | Terminated DMC

• 1 other identifier: CHOICE
• Study Type: interventional
• Target: 1,960
• Locations: 1 country
• Sites: 5

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.

Conditions

Coronary Artery Disease

Keywords

Coronary artery disease; Percutaneous coronary intervention; Drug-eluting stent

Outcome Measures

Primary Outcomes (1)

• 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

  24 months

Secondary Outcomes (10)

• Patient-oriented composite

  at 24 months

• Device-oriented composite

  12 months

• Patient-oriented composite

  12 months

• Each component of device- and patient-oriented composite

  12 months

• Each component of device- and patient-oriented composite

  24 months

Study Arms (3)

Biolimus-eluting stent

ACTIVE COMPARATOR

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

Device: Biolimus-eluting stent

Everolimus-eluting stent

ACTIVE COMPARATOR

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

Device: Everolimus-eluting stent

Zotarolimus-eluting stent

ACTIVE COMPARATOR

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

Device: Zotarolimus-eluting stent

Interventions

Biolimus-eluting stent DEVICE

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.

Also known as: Biomatrix, Biosensors, USA, Biomatrix flex, Biosensors, USA

Biolimus-eluting stent

Everolimus-eluting stent DEVICE

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.

Also known as: Xience V, Abbott, USA, Xience Prime, Abbott, USA

Everolimus-eluting stent

Zotarolimus-eluting stent DEVICE

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.

Also known as: Endeavor Resolute, Medtronic, USA, Endeavor Resolute Integrity, Medtronic, USA

Zotarolimus-eluting stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead
• Gangwon Cardiovascular Health Research Institute: collaborator

Study Sites (5)

Wonju Christian Hospital

Wŏnju, Gangwon-do, 220-701, South Korea

Location

Chonnam National University Hospital

Chuncheon, South Korea

Location

Daegu Catholic University Hospital

Daegu, South Korea

Location

Inha University Hospital

Incheon, South Korea

Location

Suncheon St. Carollo Hospital

Suncheon, South Korea

Location

Related Publications (24)

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• Youn YJ, Lee JW, Ahn SG, Lee SH, Choi HH, Choi H, Choi CU, Lee JB, Cho JH, Kang TS, Cho BR, Cha KS, Kim MH, Hyon MS, Cheong SS, Lim DS, Han KR, Jeong MH, Park KS, Yoon J. Study design and rationale of "a multicenter, open-labeled, randomized controlled trial comparing three 2nd-generation drug-eluting stents in real-world practice" (CHOICE trial). Am Heart J. 2013 Aug;166(2):224-9. doi: 10.1016/j.ahj.2013.04.014. Epub 2013 Jun 19.

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MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Biosensing Techniques

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Molecular Probe Techniques; Investigative Techniques

Study Officials

• Junghan Yoon, M.D., Ph.D.

  Wonju Chrisitian Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiology, Department of Internal Medicine

Model Details: BES EES ZES-R

Study Record Dates

• First Submitted: July 5, 2011
• First Posted: July 19, 2011
• Study Start: January 16, 2013
• Primary Completion: December 5, 2017
• Study Completion: January 1, 2019
• Last Updated: July 9, 2019

Record last verified: 2019-07

Locations

KR (5)