The Nordic-Baltic Bifurcation Study IV

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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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.

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: Implantation of coronary stent in bifurcation lesion
* Procedure: Implantation of coronary stent in bifurcation lesion


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: No side branch treatment group<br>Implantation of coronary stent in bifurcation lesion | Procedure: Implantation of coronary stent in bifurcation lesion<br>* Implantation of coronary stent in bifurcation lesion with no side branch treatment<br>* Other names: PTCA;|
| Experimental: Stenting of main vessel and side branch group<br>Implantation of coronary stent in bifurcation lesion | Procedure: Implantation of coronary stent in bifurcation lesion<br>* Implantation of coronary stent in bifurcation lesion with stenting of main vessel and side branch<br>* Other names: PTCA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCI, Bifurcation lesion