Comparison of Biolimus-eluting Biodegradable Polymer, Everolimus-eluting and Sirolimus-eluting Coronary Stents

Ajou University School of Medicine1,462 enrolled

Overview

To compare the safety and efficacy of coronary stenting with everolimus-eluting stent (Promus Element®) and biolimus-eluting stent with biodegradable polymer (Nobori®)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

1,462

Conditions

Coronary Artery Disease

Interventions

Promus Element, Boston Scientific CorporationDEVICE

Everolimus-eluting stent

Nobori, Terumo Corporation (Japan)DEVICE

Biolimus-eluting stent with biodegradable polymer

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Significant coronary artery stenosis (\> 50% by visual estimate) * Stable angina, unstable angina, Non-ST elevation myocardial infarction (NSTEMI) and documented silent ischemia * Patients eligible for intracoronary stenting * age ≥ 20 years old Exclusion Criteria: * ST segment elevation myocardial infarction (within 24 hours) * Low ejection fraction (\< 25%) * Cardiogenic shock * History of bleeding diathesis or known coagulopathy * Limited life-expectancy (less than 1 year) due to combined serious disease * Contraindication to heparin, sirolimus, everolimus and biolimus * Contraindication to aspirin and clopidogrel * Pregnancy

Locations (26)

Hallym University Sacred Heart Hospital

Anyang, South Korea

Outcomes

Primary Outcomes

The Number of Participants with Majour Adverse Cardiac Events (composite of death, myocardial infarction, target vessel revascularization and stent thrombosis

Time frame: 1 year after index procedure

Secondary Outcomes

The number of participants with majour adverse cardiac events (composite of death, myocardial infarction, target vessel revascularization and stent thrombosis

Time frame: 2 years after index procedure

Death (all-cause and cardiac)