The Nordic-Baltic Bifurcation Study IV (BIF IV)

How Should Coronary Artery Stenoses With Significant Side Branch be Stented? A Strategy of Stenting Both Main Vessel and Side Branch Compared to a Strategy of Stenting the Main Vessel and Only Stenting the Side Branch if Necessary.

How should coronary artery stenoses with significant side branch be stented?

A strategy of stenting both main vessel and side branch compared to a strategy of stenting the main vessel and only stenting the side branch if necessary.

The 2-stent strategy is superior to the 1-stent strategy regarding occurrence of cardiac death, non-procedure related myocardial infarction and re-revascularization with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Procedure: Implantation of coronary stent in bifurcation lesion; Procedure: Implantation of coronary stent in bifurcation lesion

Detailed Description

Design:

• Randomised open multicentre trial.

Patients:

• Number 450.

Randomisation:

• No side branch treatment group or stenting of main vessel and side branch group.

Evaluation of endpoints:

• Primary and secondary endpoints will be assessed by an independent endpoint committee.
• The endpoint committee will consist of experienced cardiologists with professor Kristian Thygesen, Aarhus Universitetshospital, as chairman.

Sample size calculation:

• A total of 225 patients will be included in each group, in total 450 patients. We expect a primary endpoint rate of 10% (cardiac death, non-procedure related myocardial infarction related to index lesion or TLR after 6 months) in the 1- stent strategy group and of 3% in the 2-stent strategy group. With an alpha of 5% and a strength of 80%, 194 patients will be needed in each group (two-sided chi-square test) to demonstrate this difference. The expected primary endpoint rate after 6 months is based on 6 months MACE rates and on the angiographic results in our previously published studies. In these studies, a 6 months MACE rate of 3.7% was found in the culotte group of the Nordic Stent Technique Study. Besides, an angiographic restenosis rate of 19.2% in the 1-stent strategy group in the Nordic Bifurcation Study is estimated to translate to a MACE rate of approximately 10% in the present study.

Analysis of the population:

• The results will be analyzed according to the intention-to-treat principle.

Data management:

• The study is reported to Datatilsynet (The Danish Data Protection Agency) and the agency's guidelines for data management will be followed.

Dedicated case record forms (CRF) will be used and faxed to PCI research, Cardiac Cath. Lab., Aarhus University Hospital, Skejby, DK-8200 Aarhus N, Denmark. Data will be stored in an Access database and double data entry will be used as quality control. There will be a log of accesses and attempt of accesses. Back-up data and original data will be cryptotized.

Monitoring of the study:

• The study will be monitored according to the GCP rules by independent professionals. During the study period, monitors will have regular contact to the participating departments to ensure that the trial is conducted in compliance with the protocol, GCP and applicable regulatory requirements

Publication:

• Results, positive as well as negative, will be published in an international cardiovascular journal. Publication and author issues will be decided by the steering committee on basis of general involvement in the study (drafting of protocol, core lab. function, end point committee membership, etc.) and of number of included patients.

• Study Type: Interventional
• Enrollment (Actual): 450
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus N
    • Skejby, Aarhus N, Denmark, 8200
      • Aarhus University Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Stable or unstable angina pectoris or silent angina pectoris.
• Genuine bifurcation lesion ( Medina type 1,1,1 or 1,0,1 or 0,1,1)
• Lesion of "LAD/diagonal", "Cx/obtuse marginal", "RCA-PDA/posterolateral branch" or "LM/Cx/LAD".
• Diameter of main vessel by visual estimate >3.0 mm.
• Diameter of side branch by visual estimate >2.75 mm.
• Signed informed consent.

Exclusion Criteria:

• ST-elevation infarction within 24 hours.
• Side branch lesion length >15 mm.
• Expected survival < 1 year.
• S-creatinine >200 µmol/l.
• Allergy to Aspirin, Clopidogrel or Ticlopidine.
• Allergy to Sirolimus.

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: "No side branch treatment" group; Implantation of coronary stent in bifurcation lesion	Procedure: Implantation of coronary stent in bifurcation lesion; Implantation of coronary stent in bifurcation lesion with no side branch treatment; Other Names: PCI; PTCA; Procedure: Implantation of coronary stent in bifurcation lesion; Implantation of coronary stent in bifurcation lesion with stenting of main vessel and side branch; Other Names: PCI; PTCA
Experimental: "Stenting of main vessel and side branch" group; Implantation of coronary stent in bifurcation lesion	Procedure: Implantation of coronary stent in bifurcation lesion; Implantation of coronary stent in bifurcation lesion with no side branch treatment; Other Names: PCI; PTCA; Procedure: Implantation of coronary stent in bifurcation lesion; Implantation of coronary stent in bifurcation lesion with stenting of main vessel and side branch; Other Names: PCI; PTCA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Combined endpoint of: Cardiac death, non-index procedure related myocardial infarction or target lesion revascularisation	After 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
MACE (cardiac death, non-index procedure related myocardial infarction, stent thrombosis or target lesion revasculation)	During admission, after 1, 24, 36 and 60 months.
Cardiac death.	During the admission, after 1, 6, 24, 36 and 60 months.
Non-index procedure related myocardial infarction during the admission.	After 1, 6, 24, 36 and 60 months.
Stent thrombosis.	During admission, after 1, 6, 24, 36 and 60 months.
Total mortality	During admission, after 1, 6, 24, 36 and 60 months and 10 years.
target lesion revascularisation.	During admission, after 1, 6, 24, 36 and 60 months.
target vessel revascularisation.	During admission, after 1, 6, 24, 36 and 60 months.
Index procedure related myocardial infarction based on biomarkers (CK-MB mass, TNT/TNI	During hospital period, 1, 8, 24, 36 and 60 months
CCS angina class	After 6, 8, 24, 36 and 60 months.

Collaborators and Investigators

• Sponsor: Evald Hoej Christiansen
• Collaborators: Johnson & Johnson
• Investigators: Principal Investigator: Niels R Holm, MD, MD

Publications and helpful links

General Publications

• Kumsars I, Holm NR, Niemela M, Erglis A, Kervinen K, Christiansen EH, Maeng M, Dombrovskis A, Abraitis V, Kibarskis A, Trovik T, Latkovskis G, Sondore D, Narbute I, Terkelsen CJ, Eskola M, Romppanen H, Laine M, Jensen LO, Pietila M, Gunnes P, Hebsgaard L, Frobert O, Calais F, Hartikainen J, Aaroe J, Ravkilde J, Engstrom T, Steigen TK, Thuesen L, Lassen JF; Nordic Baltic bifurcation study group. Randomised comparison of provisional side branch stenting versus a two-stent strategy for treatment of true coronary bifurcation lesions involving a large side branch: the Nordic-Baltic Bifurcation Study IV. Open Heart. 2020 Jan 19;7(1):e000947. doi: 10.1136/openhrt-2018-000947. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2008
• Primary Completion (Actual): December 1, 2012
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: December 19, 2011
• First Submitted That Met QC Criteria: December 19, 2011
• First Posted (Estimated): December 21, 2011

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 29, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: PCI; Bifurcation lesion
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: 20080192