UMIN-CTR Clinical Trial

Public title

A Multicenter, Randomized Trial to Compare 2 link Nobori and 3 link Xience Stents in Bifurcation Stenting

Acronym

Bifurcation stenting using 2 link stent Nobori versus
3 link stent Xience (BEGIN)

Scientific Title

A Multicenter, Randomized Trial to Compare 2 link Nobori and 3 link Xience Stents in Bifurcation Stenting

Scientific Title:Acronym

Bifurcation stenting using 2 link stent Nobori versus
3 link stent Xience (BEGIN)

Region

Japan

Condition

Coronary artery disease with de novo true bifurcation lesions

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To make a comparison of safety and efficacy of DESs with different link number (2-link Nobori and 3-link Xience/PROMUS) in patients with de novo true bifurcation lesions.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The minimum lumen diameter of the side branch ostium in bifurcation at 8 months after PCI.

Incidence of the Adverse events until one year after PCI.

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

2-link biolimus-eluting stent (Nobori)

Interventions/Control_2

3-link everolimus-eluting stent(Xience)

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1.Patient eligible for percutaneous coronary intervention

2. Patient or substitute decision-maker willing to provide written informed consent, which is approved by the Institutional Review Board or its equivalence

3. De novo stenosis at coronary bifurcation with up to two vessels (visually estimated diameter stenosis >= 50%).
4. Second vessel at coronary bifurcation treatable with trial device during the procedure

5. True coronary bifurcation, >=50% diameter stenosis in both the main and side branches, belonging to the Medina classes 1.1.1, 1.0.1, and 0.1.1

6. Visually estimated target lesion reference vessel diameter, 2.5-5.0 mm in the main branch, >=2.25 mm in the side branch

7. Target lesion treatable with one or two stents in both the main and side branches

8. Consensus of PCI after discussion between cardiologists and cardiac surgeons for the lesion in the left main coronary artery

9. Thrombolysis in Myocardial Infarction grade >=1 flow in both the main and side branches

Key exclusion criteria

A. General restrictions
1. Unable to be followed by the implementing medical institution
2. Life expectancy <1 year
3. Acute myocardial infarction (<1 week)
4. Left ventricular ejection fraction < 30%
5. Scheduled for elective treatment requiring antiplatelet drug withdrawal
6. Deemed as unsuitable by the investigator or sub-investigator
7. Serum creatinine level >=2.0 mg/dl

B. Vascular morphological restrictions
1. Lesion proximal to coronary artery bypass graft anastomotic site (visual estimation <=5.0 mm) or including a part of coronary artery bypass grafting
2. In-stent restenosis
3. Severe calcification

Target sample size

240

Name of lead principal investigator

1st name	keiko
Middle name
Last name	Oka

Organization

Saiseikai Yokohama City Eastern Hospital

Division name

Divison of Cardiology

Zip code

045-576-3000

Address

3-6-1 Shimosueyoshi Tsurumi-ward, Yokohama, Japan

TEL

045-576-3000

Email

bigin-trial@kchnet.or.jp

Name of contact person

1st name	keiko
Middle name
Last name	Oka

Organization

Kurashiki Central Hospital

Division name

Clinical Research Center

Zip code

710-8602

Address

1-1-1 Miwa, Kurashiki city, Okayama, Japan

TEL

086-422-0210

Homepage URL

Email

kenkyu@kchnet.or.jp

Institute

BEGIN trial investigators

Institute

Department

Personal name

Organization

Kurashiki Central Hospital

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Kurashiki Central Hospital

Address

1-1-1 Miwa, Kurashiki city, Okayama, Japan

Tel

086-422-0210

Email

kenkyu@kchnet.or.jp

Secondary IDs

YES

Study ID_1

NCT01574586

Org. issuing International ID_1

ClinicalTrials.gov

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

04

Month

16

Day

URL releasing protocol

https://doi.org/10.1007/s00380-019-01368-3

Publication of results

Published

URL related to results and publications

https://doi.org/10.1007/s00380-019-01368-3

Number of participants that the trial has enrolled

226

Results

The primary endpoints (minimumlumen diameter at the SB ostium measured at an independent core laboratory at the 8-month follow-up) were comparable(1.64 +/- 0.50 mm vs. 1.63 +/- 0.51mm, p=0.976). There was no significant difference in composite outcomes of cardiac death,myocardial infarction, or target vascular revascularization at 12 months (7.4% vs. 8.0%, p = 0.894). Two-link BES and 3-link
EES showed similar 8-month angiographic and 1-year clinical outcomes for true CBLs.

Results date posted

2021

Year

04

Month

23

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Fortysix Japanese centers participated, of which 34 enrolled patients.Inclusion criteria were as follows: Patients over 20 years with (1) de novo and true CBLs, over 50% diameter stenosis (DS) in the MV and SB belonging to Medina classes (1.1.1), (1.0.1), and (0.1.1); (2) visually estimated target lesion reference vessel diameter (RVD), 2.5-5.0 mm in the MV, and over 2.25 mm in the SB;(3) target CBLs treatable with one or two stents in both branches (treatable within 4 stents in lesions including CBLs); and (4)Thrombolysis in Myocardial Infarction (TIMI) grade over 1 flow in both branches. CBLs were defined as lesions 10 mm proximal from the carina to the MV or 5 mm distal from the carina to the MV or SB on angiography.For the left main coronary artery (LMCA) lesions, PCI consensus was obtained after discussion between the cardiologists and cardiac surgeons. One target CBL per patient treated with the study device was enrolled.

Participant flow

After a baseline angiogram was obtained, the patients were randomly assigned in a 1:1 ratio to one of the two devices:
2-link BES (Nobori, TERUMO, Tokyo) and 3-link EES
(Xience V, Prime, Xpedition, Abbott Vascular).

Adverse events

Major adverse cardiovascular events 17
Cardiac death 1
Non-cardiac death 0
Myocardial infarction 7
Target vessel revascularization 15
Target lesion revascularization 8
TLR for target bifurcation6
Stent thrombosis 3

Outcome measures

The primary endpoint of the study was angiographic MLD
at the SBO at 8 months. The secondary endpoint was the
occurrence of major adverse cardiac events (MACE) defined
as the composite of cardiac death, Q-wave or non-Q-wave
MI, or target vessel revascularization (TVR) at 12 months.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2012

Year

03

Month

28

Day

Date of IRB

2011

Year

10

Month

21

Day

Anticipated trial start date

2012

Year

04

Month

18

Day

Last follow-up date

2015

Year

06

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

04

Month

16

Day

Last modified on

2021

Year

04

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009101