NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-eluting Stent Trial (NEXT)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Biolimus-eluting stent
Everolimus-eluting stent
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary stent
Eligibility Criteria
Inclusion Criteria:
- Patients scheduled for percutaneous coronary intervention using drug-eluting stents
Sites / Locations
- Department of Cardiovascular Medicine, Kyoto University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Biolimus-eluting stent
Everolimus-eluting stent
Arm Description
Biolimus-eluting stent
Everolimus-eluting stent
Outcomes
Primary Outcome Measures
target-lesion revascularization
target-lesion revascularization
death or myocardial infarction at 3-year after stent implantation
death or myocardial infarction at 3-year after stent implantation
Secondary Outcome Measures
all-cause death
death due to any cause
cardiac death
death due to cardiac origins
acute myocardial infarction
acute myocardial infarction
stent thrombosis
stent thrombosis defined by Academic Reseach Consortium definition
stroke
stroke excluding transient ischemic attacks
bleeding complications
bleeding complications defined by GUSTO and TIMI definitions
success rate for stent deployment
success rate for stent deployment
procedure time
procedure time
clinically-driven target-lesion revascularization
clinically-driven target-lesion revascularization
non-target-lesion revascularization
non-target-lesion revascularization
coronary artery bypass grafting
coronary artery bypass grafting
target-vessel revascularization
target-vessel revascularization
any repeat coronary revascularization
any repeat coronary revascularization
composite of cardiac death, acute myocardial infarction in the territory of the target vessel or target-lesion revascularization
composite of cardiac death, acute myocardial infarction in the territory of the target vessel or target-lesion revascularization
composite of all-cause death, acute myocardial infarction or any repeat coronary revascularization
composite of all-cause death, acute myocardial infarction or any repeat coronary revascularization
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01303640
Brief Title
NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-eluting Stent Trial
Acronym
NEXT
Official Title
NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-eluting Stent Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Takeshi Morimoto
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate whether the newly-approved biolimus-eluting stent is not inferior to the everolimus-eluting stent in terms of the rate of target-lesion revascularization at 1-year and death or myocardial infarction at 3-year after stent implantation in the real world clinical practice.
Detailed Description
Everolimus-eluting stent is the most widely used coronary drug-eluting stent in Japan. Biolimus-eluting stent is a new coronary drug-eluting stent, which is going to be approved in 2011 by the Japanese Ministry of Health, Labor and Welfare. It has been reported that biolimus-eluting stent had lower rate of target-lesion revascularization and stent thrombosis at 9 months as compared with paclitaxel-eluting stent. However, trial results comparing biolimus-eluting stent with everolimus-eluting stent are largely unknown. The purpose of this study is to evaluate whether the newly-approved biolimus-eluting stent is not inferior to the everolimus-eluting stent in terms of the rate of target-lesion revascularization at 1-year and death or myocardial infarction at 3-year after stent implantation in the real world clinical practice. The design of this study is all-comer design enrolling patients scheduled for percutaneous coronary intervention using drug-eluting stents without any exclusion criteria.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary stent
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3235 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Biolimus-eluting stent
Arm Type
Active Comparator
Arm Description
Biolimus-eluting stent
Arm Title
Everolimus-eluting stent
Arm Type
Active Comparator
Arm Description
Everolimus-eluting stent
Intervention Type
Device
Intervention Name(s)
Biolimus-eluting stent
Intervention Description
Biolimus-eluting stent
Intervention Type
Device
Intervention Name(s)
Everolimus-eluting stent
Intervention Description
Everolimus-eluting stent
Primary Outcome Measure Information:
Title
target-lesion revascularization
Description
target-lesion revascularization
Time Frame
1-year
Title
death or myocardial infarction at 3-year after stent implantation
Description
death or myocardial infarction at 3-year after stent implantation
Time Frame
3-year
Secondary Outcome Measure Information:
Title
all-cause death
Description
death due to any cause
Time Frame
3-year
Title
cardiac death
Description
death due to cardiac origins
Time Frame
3-year
Title
acute myocardial infarction
Description
acute myocardial infarction
Time Frame
3-year
Title
stent thrombosis
Description
stent thrombosis defined by Academic Reseach Consortium definition
Time Frame
3-year
Title
stroke
Description
stroke excluding transient ischemic attacks
Time Frame
3-year
Title
bleeding complications
Description
bleeding complications defined by GUSTO and TIMI definitions
Time Frame
3-year
Title
success rate for stent deployment
Description
success rate for stent deployment
Time Frame
3-year
Title
procedure time
Description
procedure time
Time Frame
3-year
Title
clinically-driven target-lesion revascularization
Description
clinically-driven target-lesion revascularization
Time Frame
3-year
Title
non-target-lesion revascularization
Description
non-target-lesion revascularization
Time Frame
3-year
Title
coronary artery bypass grafting
Description
coronary artery bypass grafting
Time Frame
3-year
Title
target-vessel revascularization
Description
target-vessel revascularization
Time Frame
3-year
Title
any repeat coronary revascularization
Description
any repeat coronary revascularization
Time Frame
3-year
Title
composite of cardiac death, acute myocardial infarction in the territory of the target vessel or target-lesion revascularization
Description
composite of cardiac death, acute myocardial infarction in the territory of the target vessel or target-lesion revascularization
Time Frame
3-year
Title
composite of all-cause death, acute myocardial infarction or any repeat coronary revascularization
Description
composite of all-cause death, acute myocardial infarction or any repeat coronary revascularization
Time Frame
3-year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients scheduled for percutaneous coronary intervention using drug-eluting stents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takeshi Kimura, MD, PhD
Organizational Affiliation
Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiovascular Medicine, Kyoto University Hospital
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
29628128
Citation
Ito S, Watanabe H, Morimoto T, Yoshikawa Y, Shiomi H, Shizuta S, Ono K, Yamaji K, Soga Y, Hyodo M, Shirai S, Ando K, Horiuchi H, Kimura T. Impact of Baseline Thrombocytopenia on Bleeding and Mortality After Percutaneous Coronary Intervention. Am J Cardiol. 2018 Jun 1;121(11):1304-1314. doi: 10.1016/j.amjcard.2018.02.010. Epub 2018 Mar 1.
Results Reference
derived
PubMed Identifier
29508236
Citation
Watanabe H, Morimoto T, Shiomi H, Yoshikawa Y, Kato T, Saito N, Shizuta S, Ono K, Yamaji K, Ando K, Kaji S, Furukawa Y, Akao M, Ishikawa T, Tamura T, Yamamoto Y, Muramatsu T, Suwa S, Nakagawa Y, Kadota K, Takatsu Y, Nishikawa H, Hiasa Y, Hayashi Y, Miyazaki S, Kimura T. Mortality impact of post-discharge myocardial infarction size after percutaneous coronary intervention: a patient-level pooled analysis from the 4 large-scale Japanese studies. Cardiovasc Interv Ther. 2019 Jan;34(1):47-58. doi: 10.1007/s12928-018-0517-x. Epub 2018 Mar 5.
Results Reference
derived
PubMed Identifier
26446596
Citation
Natsuaki M, Kozuma K, Morimoto T, Kadota K, Muramatsu T, Nakagawa Y, Akasaka T, Igarashi K, Tanabe K, Morino Y, Ishikawa T, Nishikawa H, Awata M, Abe M, Okada H, Takatsu Y, Ogata N, Kimura K, Urasawa K, Tarutani Y, Shiode N, Kimura T. Final 3-Year Outcome of a Randomized Trial Comparing Second-Generation Drug-Eluting Stents Using Either Biodegradable Polymer or Durable Polymer: NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-Eluting Stent Trial. Circ Cardiovasc Interv. 2015 Oct;8(10):e002817. doi: 10.1161/CIRCINTERVENTIONS.115.002817.
Results Reference
derived
PubMed Identifier
24687156
Citation
Natsuaki M, Kozuma K, Morimoto T, Shiomi H, Kimura T. Two-year outcome of a randomized trial comparing second-generation drug-eluting stents using biodegradable or durable polymer. JAMA. 2014 May;311(20):2125-7. doi: 10.1001/jama.2014.3584. No abstract available.
Results Reference
derived
PubMed Identifier
23684673
Citation
Natsuaki M, Kozuma K, Morimoto T, Kadota K, Muramatsu T, Nakagawa Y, Akasaka T, Igarashi K, Tanabe K, Morino Y, Ishikawa T, Nishikawa H, Awata M, Abe M, Okada H, Takatsu Y, Ogata N, Kimura K, Urasawa K, Tarutani Y, Shiode N, Kimura T; NEXT Investigators. Biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent: a randomized, controlled, noninferiority trial. J Am Coll Cardiol. 2013 Jul 16;62(3):181-190. doi: 10.1016/j.jacc.2013.04.045. Epub 2013 May 15.
Results Reference
derived
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NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-eluting Stent Trial
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