Two-stent vs Provisional Stenting Techniques for Patients With Complex Coronary Bifurcation Lesions (DEFINITION-II)

A Prospective, Multi-center, Randomized Trial Comparing Two-stent With Provisional Stenting Techniques for Patients With Complex Coronary Bifurcation Lesions

The purpose of this study is to establish the optimal strategy for stenting in coronary bifurcation lesion.

Study Overview

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

Detailed Description

The current study is designed as a multicenter, randomized and prospective study aiming to compare the effect of two-stenting and simple stenting techniques in patients with complex bifurcation lesions. Based on the previous studies, the rate of 1-year target lesion failure events was around 14% after PCI with provisional stenting. And our previous data showed that this event at 12-month after two-stenting procedure was 7%. Considering the lost to follow-up, it is anticipated that up to 660 patients will be enrolled in the trial. All patients will have repeat angiography at 13 months, with clinical follow-up to 5 years.

• Study Type: Interventional
• Enrollment (Actual): 660
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210006
      • Nanjing First 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:

• Provision of informed consent prior to any study specific procedures;
• Men and women 18 years and older;.
• Established indication to PCI according to the guidelines of American Heart Association and American College of Cardiology;
• Native coronary lesion suitable for drug-eluting stent placement;
• True bifurcation lesions (Medina 0,1,1/1,1,1);
• Reference vessel diameter in side branch ≥2.5mm by visual estimation;
• Complex bifurcation lesions based on DEFINITION study.

Exclusion Criteria:

• Pregnancy and breast feeding mother;
• Co-morbidity with an estimated life expectancy of < 50 % at 12 months;
• Scheduled major surgery in the next 12 months;
• Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk;
• Unable to provide written informed consent, or fail to follow the protocol;
• Previous enrolment in coronary intervention device investigation during the study period;
• Patient with STEMI within 24-hour from the onset of chest pain to admission;
• Restenosis bifurcation lesions.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Two-stenting technique; Percutaneous coronary intervention with DK crush, or culotte technique	Procedure: Percutaneous coronary intervention; Other Names: PCI
Active Comparator: Provisional stenting technique; Percutaneous coronary intervention with Provisional stenting technique. Stenting of the side branch was required if TIMI flow was <3, or ≥ type B dissection after kissing balloon inflation.	Procedure: Percutaneous coronary intervention; Other Names: PCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target lesion failure	Combined end point of: cardiac death, target-vessel myocardial infarction (MI), or target lesion revascularization (TLR).	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Stent thrombosis	12 months
Cardiac death	12 months
Target-vessel myocardial infarction	12 months
Target lesion revascularisation	12 months
Target vessel revascularisation	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute gain	The acute gain was defined as the difference between post- and preprocedural minimal lumen diameter (MLD)	Intraoperative
In-stent restenosis	In-stent restenosis was defined as ≥50% diameter stenosis at the follow-up angiogram.	13 months
Late lumen loss	The late lumen loss was defined as the difference between post- and follow-up minimal lumen diameter (MLD)	13 months

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University
• Investigators: Principal Investigator: Shao-Liang Chen, MD, Nanjing First Hospital, Nanjing Medical University

Publications and helpful links

General Publications

• Kan J, Zhang JJ, Sheiban I, Santoso T, Munawar M, Tresukosol D, Xu K, Stone GW, Chen SL; DEFINITION II Investigators. 3-Year Outcomes After 2-Stent With Provisional Stenting for Complex Bifurcation Lesions Defined by DEFINITION Criteria. JACC Cardiovasc Interv. 2022 Jul 11;15(13):1310-1320. doi: 10.1016/j.jcin.2022.05.026.
• Zhang JJ, Ye F, Xu K, Kan J, Tao L, Santoso T, Munawar M, Tresukosol D, Li L, Sheiban I, Li F, Tian NL, Rodriguez AE, Paiboon C, Lavarra F, Lu S, Vichairuangthum K, Zeng H, Chen L, Zhang R, Ding S, Gao F, Jin Z, Hong L, Ma L, Wen S, Wu X, Yang S, Yin WH, Zhang J, Wang Y, Zheng Y, Zhou L, Zhou L, Zhu Y, Xu T, Wang X, Qu H, Tian Y, Lin S, Liu L, Lu Q, Li Q, Li B, Jiang Q, Han L, Gan G, Yu M, Pan D, Shang Z, Zhao Y, Liu Z, Yuan Y, Chen C, Stone GW, Han Y, Chen SL. Multicentre, randomized comparison of two-stent and provisional stenting techniques in patients with complex coronary bifurcation lesions: the DEFINITION II trial. Eur Heart J. 2020 Jul 14;41(27):2523-2536. doi: 10.1093/eurheartj/ehaa543.
• Zhang JJ, Gao XF, Han YL, Kan J, Tao L, Ge Z, Tresukosol D, Lu S, Ma LK, Li F, Yang S, Zhang J, Munawar M, Li L, Zhang RY, Zeng HS, Santoso T, Xie P, Jin ZN, Han L, Yin WH, Qian XS, Li QH, Hong L, Paiboon C, Wang Y, Liu LJ, Zhou L, Wu XM, Wen SY, Lu QH, Yuan JQ, Chen LL, Lavarra F, Rodriguez AE, Zhou LM, Ding SQ, Vichairuangthum K, Zhu YS, Yu MY, Chen C, Sheiban I, Xia Y, Tian YL, Shang ZL, Jiang Q, Zhen YH, Wang X, Ye F, Tian NL, Lin S, Liu ZZ, Chen SL. Treatment effects of systematic two-stent and provisional stenting techniques in patients with complex coronary bifurcation lesions: rationale and design of a prospective, randomised and multicentre DEFINITION II trial. BMJ Open. 2018 Mar 6;8(3):e020019. doi: 10.1136/bmjopen-2017-020019. Erratum In: BMJ Open. 2018 Dec 4;8(12):e020019corr1.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: October 29, 2014
• First Submitted That Met QC Criteria: November 4, 2014
• First Posted (Estimate): November 6, 2014

Study Record Updates

• Last Update Posted (Actual): December 16, 2019
• Last Update Submitted That Met QC Criteria: December 12, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Bifurcation lesion; Percutaneous coronary intervention
• 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: NFH20141029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO