UMIN-CTR Clinical Trial

Public title

NOBORI Biolimus-Eluting versus XIENCE/PROMUS Everolimus-eluting Stent Trial
Extended Follow-up

Acronym

NEXT Trial: Extended Follow-up Study

Scientific Title

NOBORI Biolimus-Eluting versus XIENCE/PROMUS Everolimus-eluting Stent Trial
Extended Follow-up

Scientific Title:Acronym

NEXT Trial: Extended Follow-up Study

Region

Japan

Condition

Coronary Artery Disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the efficacy and safety of Biolimus-eluting stent.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Efficacy: Any target lesion revascularization within 10 years after percutaneous coronary intervention.
Safety: The composite of cardiac death and myocardial infarction within 10 years after percutaneous coronary intervention.

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

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

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Of the 3,235 patients enrolled in the NEXT study (1,617 BES and 1,618 EES), the patients whose 10-year follow-up data were available.

Key exclusion criteria

No specific exclusion criteria are defined.

Target sample size

2720

Name of lead principal investigator

1st name	Takeshi
Middle name
Last name	Kimura

Organization

Kyoto University Graduate School of Medicine

Division name

Department of Cardiovascular Medicine

Zip code

606-8507

Address

54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto

TEL

075-751-4254

Email

taketaka@kuhp.kyoto-u.ac.jp

Name of contact person

1st name	Hirotoshi
Middle name
Last name	Watanabe

Organization

Kyoto University Graduate School of Medicine

Division name

Department of Cardiovascular Medicine

Zip code

606-8507

Address

54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto

TEL

075-751-4254

Homepage URL

Email

hwatanab@kuhp.kyoto-u.ac.jp

Institute

Research Institute for Production Development

Institute

Department

Personal name

Organization

Research Institute for Production Development

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Kyoto University Graduate School and Faculty of Medicine, Ethics Committee

Address

Yoshida-Konoe-cho, Sakyo-ku, Kyoto, JAPAN

Tel

075-753-4642

Email

ethcom@kuhp.kyoto-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

時計台記念病院(北海道), 王子総合病院(北海道), 北海道循環器病院(北海道), 手稲渓仁会病院(北海道), 北光記念病院(北海道), 青森県立中央病院(青森県), 岩手県立中央病院(岩手県), 岩手医科大学附属病院(岩手県), 東北医科薬科大学病院(宮城県), 仙台オープン病院(宮城県), 福島県立医科大学附属病院(福島県), 埼玉県立循環器･呼吸器病センター　(埼玉県), 獨協医科大学埼玉医療センター(埼玉県), 新東京病院(東京都), 順天堂大学医学部附属順天堂医院(東京都), 榊原記念病院(東京都), NTT東日本関東病院(東京都), 心臓血管研究所付属病院(東京都), 帝京大学医学部附属病院(東京都), 三井記念病院(東京都), 東京医科大学病院(東京都), 東京女子医科大学病院(東京都), 板橋中央総合病院(東京都), 横浜労災病院(神奈川県), 東海大学医学部付属病院(神奈川県), 横浜市立大学附属市民総合医療センター(神奈川県), 北里大学病院(神奈川県), 金沢循環器病院(石川県), 福井大学医学部附属病院(福井県), 福井循環器病院(福井県), 大垣市民病院(岐阜県), 順天堂大学医学部附属静岡病院(静岡県), 静岡県立総合病院(静岡県), 岡村記念病院(静岡県), 聖隷浜松病院(静岡県), 浜松医療センター(静岡県), 愛知医科大学病院(愛知県), トヨタ記念病院(愛知県), 藤田医科大学病院(愛知県), 名古屋第二赤十字病院(愛知県), 永井病院(三重県), 三重大学医学部附属病院(三重県), 三重ハートセンター(三重県), 四日市羽津医療センター(三重県), 湖東記念病院(滋賀県), 滋賀医科大学医学部附属病院(滋賀県), 京都大学医学部附属病院(京都府), 三菱京都病院(京都府), 京都医療センター(京都府), 大阪府済生会野江病院(大阪府), 大阪赤十字病院(大阪府), 国立循環器病研究センター病院(大阪府), 住友病院(大阪府), ベルランド総合病院(大阪府), 神戸市立医療センター中央市民病院(兵庫県), 神戸大学医学部附属病院(兵庫県), 関西ろうさい病院(兵庫県), 兵庫県立尼崎総合医療センター(兵庫県), 天理よろづ相談所病院(奈良県), 日本赤十字社和歌山医療センター(和歌山県), 和歌山県立医科大学附属病院　(和歌山県), 鳥取大学医学部附属病院(鳥取県), 松江赤十字病院(鳥取県), 心臓病センタ－榊原病院(岡山県), 倉敷中央病院(岡山県), 川崎医科大学附属病院(岡山県), 広島市立広島市民病院(広島県), 岩国医療センター(山口県), 近森病院(高知県), 産業医科大学病院(福岡県), 福岡和白病院(福岡県), 久留米大学病院(福岡県), 小倉記念病院(福岡県), 光晴会病院(長崎県), 済生会熊本病院(熊本県), 国立病院機構熊本医療センター(熊本県), 宮崎市郡医師会病院(宮崎県), 天陽会中央病院(鹿児島県), 鹿児島医療センター(鹿児島県)

Date of disclosure of the study information

2021

Year

04

Month

27

Day

URL releasing protocol

There is no page that publishes research protocols

Publication of results

Published

URL related to results and publications

https://eurointervention.pcronline.com/article/biodegradable-or-durable-polymer-drug-eluting-stents-

Number of participants that the trial has enrolled

2417

Results

From May to October 2011, NEXT enrolled a total of 3,241 patients from 98 centres in Japan. The current study population consisted of 2,417 patients (1,204 patients with BP-BES and 1,213 with DP-EES) from 66 centres that agreed to participate in the extended study. Complete 10-year follow-up was achieved in 87.5% of patients. The cumulative 10-year incidence of death or MI was 34.0% in the BP-BES group and 33.1% in the DP-EES group (hazard ratio [HR] 1.04, 95% confidence interval [CI]: 0.90-1.20; p=0.58).

Results date posted

2023

Year

09

Month

21

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

The mean age was 69 years, 77% were male, and the mean BMI was 24.1. The rate of diabetes mellitus was 46%, 30% had previous myocardial infarction, and 51% had previous PCI. 16% of patients had ACS, 51% had multivessel disease, and 1.24 lesions were treated per patient with a mean lesion length of 19.5 mm and a mean reference vessel diameter of 2.62 mm. The mean number of stents used was 1.58, and the total stent length was 32.8 mm.

Participant flow

A complete 10-year follow-up was achieved in 2114 patients (87.5%).

Adverse events

The adverse events observed in this study are generally in the category of adverse events that occur in post-PCI practice, and no adverse events attributable to the conduct of the study were identified.

Outcome measures

For the present analysis, the primary efficacy endpoint was any target lesion revascularization (TLR), while the primary safety endpoint was a composite of death or myocardial infarction (MI).
Other pre-specified outcome measures included clinically-driven TLR, target vessel revascularization (TVR), any coronary revascularization, all-cause death, cardiac death, MI, stent thrombosis, hospitalization for heart failure, stroke, bleeding, a device-oriented composite (cardiac death, target-vessel MI, and TLR), a patient-oriented composite (all-cause death, MI, and any repeat coronary revascularization), target-lesion failure (TLF: cardiac death, target-vessel MI, or ischemia-driven TLR), target-vessel failure (TVF: cardiac death, MI, or ischemia-driven TVR), and major adverse cardiac events (MACE: cardiac death, MI, or ischemia-driven TLR).

Plan to share IPD

IPD sharing Plan description

Recruitment status

Main results already published

Date of protocol fixation

2020

Year

10

Month

04

Day

Date of IRB

2020

Year

12

Month

03

Day

Anticipated trial start date

2021

Year

05

Month

02

Day

Last follow-up date

2021

Year

12

Month

31

Day

Date of closure to data entry

2021

Year

12

Month

31

Day

Date trial data considered complete

Date analysis concluded

Other related information

The patients participating in the original NEXT study who can be followed for 10 years will be monitored.

Registered date

2021

Year

04

Month

27

Day

Last modified on

2023

Year

09

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050295