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

Not Applicable

Terminated

• Conditions: Coronary Artery Disease
• Interventions: Device: Everolimus-eluting stent; Device: Zotarolimus-eluting stent; Device: Biolimus-eluting stent

• Registration Number: NCT01397175
• Lead Sponsor: Yonsei University

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.

Study Timeline

• Study First Submitted: 2011-07-05
• Study First Submitted QC: 2011-07-18
• Study First Posted: 2011-07-19
• Study Start: 2013-01-16
• Primary Completion: 2017-12-05
• Study Completion: 2019-01-01
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-05
• Last Update Posted: 2019-07-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1960

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Everolimus-eluting stent	Everolimus-eluting stent	Xience Prime stent, Abbott, USA Xience V stent, Abbott, USA
Zotarolimus-eluting stent	Zotarolimus-eluting stent	Endeavor resolute, Medtronic, USA Endeavor resolute integrity, Medtronic, USA
Biolimus-eluting stent	Biolimus-eluting stent	Biomatrix stent, Biosensors, USA Biomatrix Flex stent, Biosensors, USA

Primary Outcome Measures

Name	Time	Method
Device-oriented composite	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

Secondary Outcome Measures

Name	Time	Method
Patient-oriented composite	12 months	Patient-oriented composite at 12-month clinical follow-up
Device-oriented composite	12 months	Device-oriented composite at 12-month clinical follow-up
Bleeding complications defined by BARC definition	before discharge	Bleeding complications defined by BARC definition before discharge
Each component of device- and patient-oriented composite	24 months	Each component of device- and patient-oriented composite at 24 months
ARC defined stent thrombosis	24 months	ARC defined stent thrombosis at 24 months
Stent thrombosis	24 months	ARC defined stent thrombosis at 24 months after randomization

Trial Locations

Locations (5)

Chonnam National University Hospital; 🇰🇷 Chuncheon, Korea, Republic of

Wonju Christian Hospital; 🇰🇷 Wonju, Gangwon, Korea, Republic of

Inha University Hospital; 🇰🇷 Incheon, Korea, Republic of

Daegu Catholic University Hospital; 🇰🇷 Daegu, Korea, Republic of

Suncheon St. Carollo Hospital; 🇰🇷 Suncheon, Korea, Republic of