Comparison of the Biolimus A9-eluting Stent With the Zotarolimus -Eluting Stent in Multi-vessel PCI

Prospective,Multicenter Study of Randomized Comparison of the Biolimus A9-eluting Stent With the Zotarolimus-eluting Stent in Multi-vessel PCI

The risk of restenosis in the treatment of coronary artery disease has significantly lessened thanks to the introduction of Drug eluting stent.

Yet, debates on the efficacy and safety of stents in complex lesions or patients have been circulated.

Recently, PCI in multiple lesions is universally performed with the development of effective stents in various kinds in the clinics.

However, a randomized study is rare for multi-vessel coronary artery disease in real procedural environments.

The primary purpose of this study is to evaluate the clinical progress of biolimus A9-eluting stent and zotarolimus-eluting stent in multi-vessel coronary artery disease.

Study Overview

• Status: Completed
• Conditions: Multivessel Coronary Artery Disease
• Intervention / Treatment: Procedure: Percutaneous Coronary Intervention

Detailed Description

The patients who need multi-vessel stenting with multi-vessel coronary artery disease will be enrolled.Each randomization of the enrolled subjects will be done 1:1 (biolimus A9-eluting stent : zotarolimus-eluting stent). Randomization will be stratified by two factors: Diabetes mellitus and Acute coronary syndrome.Clinical follow-up will occur at the following time points; 1 month, 1 year and 2 years.

• Study Type: Interventional
• Enrollment (Actual): 932
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Kosin University Hospital
  • Daegu, Korea, Republic of
    • Daegu Catholic University Medical Center
  • Daegu, Korea, Republic of
    • Daegu Fatima Hospital
  • Daegu, Korea, Republic of
    • Kyungpook National University Hospital
  • Daegu, Korea, Republic of
    • Yeungnam University Hospital
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Chonnam
    • Kwangju, Chonnam, Korea, Republic of
      • Chonnam National University Hospital
  • Gyeongbuk
    • Ulsan, Gyeongbuk, Korea, Republic of
      • Ulsan University Hospital
  • Kyeongki
    • Ilsan, Kyeongki, Korea, Republic of
      • Inje University Ilsan Paik Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients who need multi-vessel stenting with multi-vessel disease
• patients with signed informed consent

Exclusion Criteria:

• known contraindication to any of the following medications: Aspirin,clopidogrel, heparin, contrast agent, Biolimus or Zotarolimus group
• Cardiogenic shock
• Pregnant women or women with potential childbearing
• End-stage diseases with life expectancy shorter than 2 years
• patients with other Drug eluting stents implanted
• Patients requiring modification of antiplatelet agents for planned major surgery within the first 12 months after the enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biolimus A9 eluting stent; biolimus A9 stent( Biomatrix or Biomatrix Flex) will be placed in under Percutaneous Coronary Intervention.	Procedure: Percutaneous Coronary Intervention; Percutaneous Transluminal coronary angioplasty and Intervention will be performed in both of randomized groups of biolimus A9 eluting stent and zotarolimus eluting stent; Other Names: -Resolute Integrity; -Biomatrix; -Biomatrix Flex
Active Comparator: Zotarolimus-eluting stent; zotarolimus eluting stent (Resolute Integrity) will be placed in under Percutaneous Coronary Intervention.	Procedure: Percutaneous Coronary Intervention; Percutaneous Transluminal coronary angioplasty and Intervention will be performed in both of randomized groups of biolimus A9 eluting stent and zotarolimus eluting stent; Other Names: -Resolute Integrity; -Biomatrix; -Biomatrix Flex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2-year composite end points	All cause death, non fatal myocardial infarction, any revascularization	up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All cause death	All cause death	up to 2 years
non-cardiac death	non-cardiac death	up to 2 years
cardiac death	cardiac death	up to 2 years
non fatal myocardial infarction	non fatal myocardial infarction	up to 2 years
Any revascularization	Any revascularization	up to 2 years
Target lesion revascularization	Target lesion revascularization	up to 2 years
Target vessel revascularization	Target vessel revascularization	up to 2 years
stent thrombosis	stent thrombosis	up to 2 years

Collaborators and Investigators

• Sponsor: Keimyung University Dongsan Medical Center
• Investigators: Principal Investigator: Chang-Wook Nam, Postdoctoral, Keimyung University Dongsan Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: September 12, 2013
• First Submitted That Met QC Criteria: September 17, 2013
• First Posted (Estimate): September 20, 2013

Study Record Updates

• Last Update Posted (Actual): September 1, 2021
• Last Update Submitted That Met QC Criteria: August 31, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: multivessel stenting
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: BATTLE IN MULTI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No