Clinical trial NCT01254981: SORT-OUT V - Randomised Clinical Comparative Study of the Nobori and the Cypher Stent.
Official title: Randomized Clinical Comparative Study of the Nobori and the Cypher Stents in Unselected Subjects With Ischemic Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Angina Pectoris
Keywords: Percutaneous coronary intervention
DES
Angina pectoris
Stent
Lead sponsor: Aarhus University Hospital Skejby
Sponsor class: OTHER
Collaborators: name: Terumo Europe N.V.
name: Johnson & Johnson
First posted: 2010-12-07
Enrollment: 2504
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To perform a randomized comparison between the Cypher Select+ stent and the Nobori stent in the treatment of unselected patients with ischaemic heart disease.

Detailed description: 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, Aarhus, 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, \[Hjertemedicinsk Afdeling\], Aarhus University Hospital, Skejby.

Eligibility criteria: Inclusion Criteria:

All patients eligible for treatment with one or several drug-eluting coronary stents at one of the four heart centers in Odense, Skejby, Aalborg or Varde can be included in the study.

The patients will be treated in accordance with the criteria applicable at the individual sites. The indication for using DES varies slightly between the four sites, as the indication for implantation of DES is based on clinical and angiographic criteria with the financial constraints applying at the individual site. Basically, DES will be chosen instead of BMS in patients with an estimated increased risk of restenosis, in patients with the following stenosis types: Long lesions, lesions in small vessels, bifurcations, ostial lesions, in-stent restenoses and stenosis in the proximal segment of the anterior descending branch. Furthermore, DES will also be chosen for diabetics and in the left main.

Exclusion Criteria:

* The patient does not wish to participate
* The patient is participating in other randomized stent studies
* Life expectancy \< 1 year
* Allergic to Aspirin, clopidogrel, prasugrel or ticlopidin
* Allergic to sirolimus or biolimus

Primary outcomes:
measure: Primary outcome
timeFrame: Within 9 months
Secondary outcomes:
measure: Secondary outcome
measure: Major Adverse Coronary Events
timeFrame: 30 days
measure: Target lesion revascularisation defined as repeated revascularisation of an index lesion at PCI or bypass surgery.
timeFrame: 9 and 12 months and 3 years
measure: Death
timeFrame: 30 days and 9 months
measure: Acute Myocardial Infarction
timeFrame: 30 days and 9 months
measure: Stent thrombosis
timeFrame: 12, 24 and 36 months
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital, Skejby
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Aarhus University Hospital Skejby
name: Evald H Christiansen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Christiansen EH, Jensen LO, Thayssen P, Tilsted HH, Krusell LR, Hansen KN, Kaltoft A, Maeng M, Kristensen SD, Botker HE, Terkelsen CJ, Villadsen AB, Ravkilde J, Aaroe J, Madsen M, Thuesen L, Lassen JF; Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT) V investigators. Biolimus-eluting biodegradable polymer-coated stent versus durable polymer-coated sirolimus-eluting stent in unselected patients receiving percutaneous coronary intervention (SORT OUT V): a randomised non-inferiority trial. Lancet. 2013 Feb 23;381(9867):661-9. doi: 10.1016/S0140-6736(12)61962-X. Epub 2013 Jan 30.