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

Ajou University School of Medicine

Status and phase: Unknown; Phase 4

Conditions: Coronary Artery Disease

Treatments: Device: Promus Element, Boston Scientific Corporation; Device: Nobori, Terumo Corporation (Japan)

Study type: Interventional

Funder types: Other

Identifiers

NCT01268371

BESS

Details and patient eligibility

About

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

Enrollment: 1,462 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,462 participants in 2 patient groups

Promus Element

Active Comparator group

Description:

Everolimus-eluting stent

Treatment:

Device: Promus Element, Boston Scientific Corporation

Nobori

Active Comparator group

Description:

Biolimus-eluting stent with biodegradable polymer

Treatment:

Device: Nobori, Terumo Corporation (Japan)