Clinical trial NCT01397175: BES, EES, and ZES-R in Real World Practice
Official title: A Multicenter, Open-labeled, Randomized Controlled Trial Comparing Three 2nd Generation Drug-Eluting Stents in Real-World Practice
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Coronary artery disease
Percutaneous coronary intervention
Drug-eluting stent
Lead sponsor: Yonsei University
Sponsor class: OTHER
Collaborators: name: Gangwon Cardiovascular Health Research Institute
First posted: 2011-07-19
Enrollment: 1960
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: BES EES ZES-R
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Device-oriented composite
timeFrame: 24 months
Secondary outcomes:
measure: Patient-oriented composite
timeFrame: at 24 months
measure: Device-oriented composite
timeFrame: 12 months
measure: Patient-oriented composite
timeFrame: 12 months
measure: Each component of device- and patient-oriented composite
timeFrame: 12 months
measure: Each component of device- and patient-oriented composite
timeFrame: 24 months
measure: ARC defined stent thrombosis
timeFrame: 12 months
measure: ARC defined stent thrombosis
timeFrame: 24 months
measure: Stent thrombosis
timeFrame: 12 months
measure: Stent thrombosis
timeFrame: 24 months
measure: Bleeding complications defined by BARC definition
timeFrame: before discharge
Other outcomes:
Locations:
city: Wonju
country: Korea, Republic of
facility: Wonju Christian Hospital
state: Gangwon
city: Chuncheon
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Suncheon
country: Korea, Republic of
facility: Suncheon St. Carollo Hospital
Study officials:
affiliation: Wonju Chrisitian Hospital
name: Junghan Yoon, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
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