The Nordic-Baltic Bifurcation Study IV

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.

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.