SORT-OUT V - Randomised Clinical Comparative Study of the Nobori and the Cypher Stent.

• Primary outcome [ Time Frame: Within 9 months ] [ Designated as safety issue: Yes ]
  Major Adverse Cardiac Events, such as cardiac death, myocardial infarction, stent thrombosis or target lesion revascularisation: repeated revascularisation of an index lesion at PCI or bypass surgery
  
  

• Secondary outcome [ Designated as safety issue: Yes ]
  • Device success rate defined as the frequency of a successful implantation of the study stent in all the stenoses scheduled to be treated with residual stenosis < 20
  • Procedural success rate defined as the frequency of successful implantation of the study stent in all the stenoses scheduled to be treated with residual stenosis < 20% and without serious complications (MACE = Major Adverse Coronary Events))
  • Procedural time defined as time from guiding catheter in to guiding catheter out
  • X-ray time
  • Use of contrast medium
  
  
• Major Adverse Coronary Events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  Cardiac death, myocardiel infarction, target vessel revascularisation: repeated revascularisation of an index lesion at PCI or bypass surgery
  
  
• Target lesion revascularisation defined as repeated revascularisation of an index lesion at PCI or bypass surgery. [ Time Frame: 9 and 12 months and 3 years ] [ Designated as safety issue: Yes ]
  
• Death [ Time Frame: 30 days and 9 months ] [ Designated as safety issue: Yes ]
  
• Acute Myocardiel Infarction [ Time Frame: 30 days and 9 months ] [ Designated as safety issue: Yes ]
  
• Stent thrombosis [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: Yes ]
  Defined in accordance with the ARC definition of stent thrombosis
  
  

All patients to be treated with one or several drug-eluting coronary stents at one of the four heart centers in Odense, Skejby, Aalborg and Varde can be included in the study. All patients enrolled in the study will be hospitalized at one of the heart centers mentioned. Patients will not be recruited via advertisements.

The study is designed as a non-inferiority study, where the objective is to prove that Nobori is Δ0 poorer as a maximum than Cypher select+. The nine-month event rate (cardiac death, MI and/or TVR) in the Cypher stent group of SORT OUT 3 was 3.0%

The calculation of power below has been made under the following assumptions:

P (Cypher) = 0.03

There is no good estimate for the event rate related to the Nobori stent. α = 0.05 - one-sided

1-β = 0.80

Based on the various values of Δ0 the necessary number of patients, N, in each group can be calculated (StudySize Version 2.0.4, Creostat):

• Δ0 *N in each group
• 0.0025 *57,589
• 0.005 *14,397
• 0.010 *3,599
• 0.015 *1,599
• 0.020 *900

According to the above assumptions, a total of 900 patients must be included in each group in order to reject a null hypothesis that the event rate in the Nobori group is more than 2 percentage points (0.02) poorer than the event rate in the Cypher group or that Nobori is inferior to Cypher, (H0: pNobori - pCypher ≥ Δ0 = 0.02). The alternative hypothesis (HA: pN - pS < Δ0) provides that Nobori is non-inferior to Cypher - with the selected limit for non-inferiority.

Assuming an inclusion rate of 200 patients per month, it will be possible to include 2000 patients in 10 months.

Power is almost 0.9 if the inclusion is increased to a little over 2400.

Organization

The study is headed by a steering committee, in which PCI operators will participate from each of the participating sites.

Evald Høj Christiansen, Århus, will be Principal Investigator. At present, the other members of the steering committee are: Jens Flensted Lassen (chairman), Leif Thuesen, Jan Ravkilde, Hans-Henrik Tilsted, Per Thayssen and Lisette Okkels Jensen. All members of the steering committee will be given full access to the database and will take part in the interpretation of data.

The study secretariat and the randomization computer are localized at the Department of Cardiology, [Hjertemedicinsk Afdeling], Århus University Hospital, Skejby.