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Biolimus-eluting biodegradable polymer-coated stent versus a durable polymer-coated sirolimus-eluting stent in unselected patients receiving percutaneous coronary
intervention
SORT-OUT V: 3-year outcome
Evald Høj Christiansen, Lisette Okkels Jensen, Per Thayssen, Hans Henrik Tilsted, Lars Romer Krusell, Knud Nørregaard Hansen, Anne Kaltoft, Michael Maeng, Jan Ravkilde, Jens Flensted Lassen
Aarhus University Hospital ,Skejby ; Aalborg University Hospital; Odense University Hospital , Denmark
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Potential conflicts of interest
Speaker's name: Evald H Christiansen
� I have the following potential conflicts of interest to report:
Cordis, Johnson & Johnson: Research grants. Terumo: Research grants
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• After implantation of the permanent-polymer coated sirolimus-eluting Cypher stent the risk of restenosis is low, but the risk of stent thrombosis is a concern
• Stent thrombosis may be related to the permanent polymer
• The biolimus-eluting Nobori stent has a biodegradable polymer coating, and the long-term risk of major adverse cardiac events after implantation may be reduced
Background
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SORT OUT V OBJECTIVE
To compare the efficacy and safety of the sirolimus-eluting Cypher stent and the biolimus-eluting Nobori stent in an all-comer population ClinicalTrials.gov Identifier: NCT01254981
SORT OUT V OBJECTIVE
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Major Adverse Cardiac Events at 9 months composite of cardiac death, myocardial infarction, definite stent thrombosis and clinically driven target vessel revascularization Presented at PCR 2012 Today: 3-year follow-up
Primary endpoint
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Criteria of inclusion � 18 years of age or older � Chronic stable coronary artery disease or acute coronary syndromes
Criteria of exclusion � Life expectancy less than one year � Allergy to aspirin, clopidogrel, sirolimus, or biolimus � Participation in another randomized trial � Unacceptable risk by 12-month dual antiplatelet treatment � Unable to provide written informed consent No restrictions were placed on number of treated lesions or treated vessels or lesion length
Patient Population Inclusion period: July 2009 to January 2011
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Randomization
Danish Civil Registration System National Patient Registry
Western Denmark Heart Registry
Hospital admission
Cardiac Non-cardiac TVR / TLR
ISR Definite ST
MI, UAP, SAP
Non-cardiac
Event detection at follow-up
Death PCI and CABG
Clinical event detection
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Consort flow diagram
Analysis
Follow-Up
Assessed for eligibility (n=7570) Excluded (n=1857) Not meeting inclusion criteria (n=1616) Enrolled in another study (n=241)
3-year clinical follow-up N = 1228 patients
Lost to follow-up (n=1 , due to emigration)
BIOLIMUS-ELUTING NOBORI STENT N =1229 In 36 patients study stent not implanted
Lost to follow-up (n=0)
SIROLIMUS-ELUTING CYPHER SELECT+ STENT N =1239 In 31 patients study stent not implanted
3-year clinical follow-up N = 1239 patients
Enrolled and randomized (n=2468)
Eligible (n=5713)
Eligible, not included (n= 3245)
Index PCI
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Patient Characteristics
BIOLIMUS-ELUTING NOBORI STENT
SIROLIMUS-ELUTING CYPHER STENT
p
No. of patients 1229 1239
Age (years) 65.0 ±10.6 65.2 ±10.3 0.51
Male gender 74.6 % 75.1 % 0.79
Diabetes 15.1 % 15.3 % 0.89
Hypertension 57.7 % 54.7 % 0.30
Lipid-lowering therapy 60.0 % 61.1 % 0.81
Current smoker 33.6 % 33.1 % 0.78
Prior CABG 8.1 % 5.9 % 0.04
Prior PCI 17.3 % 16.5 % 0.56
Prior myocardial infarction 17.7 % 17.3 % 0.82
Body mass Index (kg/m2) 27.5 ± 5.2 27.4 ± 5.2 0.66
Patient Characteristics
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Patient Characteristics
BIOLIMUS-ELUTING NOBORI STENT
SIROLIMUS-ELUTING CYPHER STENT
p
No. of patients 1229 1239
Indication for PCI 0.71
Stable angina 49.5 % 48.1 %
NSTEMI / unstable angina 30.3 % 31.0 %
STEMI 18.3 % 18.3 %
Other 2.0 % 2.6 %
Patient Characteristics
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Lesion Characteristics BIOLIMUS-ELUTING
NOBORI STENT SIROLIMUS-ELUTING
CYPHER STENT p
No. of lesions 1,532 1555
Target lesion location 0.34
Left main artery 1.4 1.4
Left anterior descending artery 40.7 40.9
Left circumflex artery 23.2 22.5
Right coronary artery 33.2 34.4
Saphenous vein graft 1.6 0.8
Lesion type B2/C 61.0 58.8 0.25
Bifurcation lesions 15.0 15.1 0.98
Chronic total occlusions 6.0 7.2 0.21
Lesion lenght > 18 mm 34.1 33.6 0.80
Reference vessel size (mm) 3.2 ( 3.0 - 3.5) 3.3 ( 3.0 - 3.6) 0.03
Lesion Characteristics
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Lesion Characteristics
BIOLIMUS-ELUTING NOBORI STENT
SIROLIMUS-ELUTING CYPHER STENT
p
No. of lesions per patient 1.25 1.26 0.71
No. of stents
Per patient, median 1.0 ( 1.0 - 2.0) 1.0 ( 1.0 - 2.0) 0.77
> 1 stent 37.1 % 37.6 % 0.80
Total stent length (mm) 22.0 ( 14.0 - 32.0) 23.0 ( 13.0 - 33.0) 0.22
Direct stenting 21.6 % 22.4 % 0.60
Maximum pressure (atm) 16.0 ( 14.0 - 20.0) 18.0 ( 15.0 - 20.0) <.0001
Stent delivery failure 2.9 % 2.6 % 0.60
Use of GP IIb/IIIa inhib. 15.9 % 16.9 % 0.51
Procedural Characteristics
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Nobori 4.1% vs. Cypher 3.2% Pnon-inferiority = 0.06
1º Endpoint: Major Adverse Cardiac Events (Cardiac death, myocardial infarction, definite stent thrombosis, target vessel revascularization)
PCR 2012, 9 months
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Major Adverse Cardiac Events, 3 year (Cardiac death, myocardial infarction, definite stent thrombosis, target vessel revascularization)
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Cypher 11.2 % OR=0.90
95% CI (0.69-1.16) P=0.41
Major Adverse Cardiac Events, 3 year (Cardiac death, myocardial infarction, definite stent thrombosis, target vessel revascularization)
Cypher Nobori
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OR=0.84 95% CI (0.51-1.37)
P=0.49
Nobori 2.4 %
Cypher 3.0 %
Cardiac Death, 3 year
Cypher Nobori
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OR=1.08 95% CI (0.70-1.65)
P=0.73
Cypher 3.5 %
Nobori 3.7 %
Myocardial Infarction, 3 year
Cypher Nobori
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OR=1.33 95% CI (0.64-2.81)
P=0.45 Nobori 1.4 %
Cypher 1.0 %
Definite Stent Thrombosis, 3 year
Cypher Nobori
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OR=0.94 95% CI (0.68-1.28)
P=0.69 Cypher 7.0 %
Nobori 6.6 %
Target Vessel Revascularization, 3 year
Cypher Nobori
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Conclusion
� At 9 month the biolimus-eluting Nobori stent was not found to be non-inferior to the sirolimus-eluting Cypher stent
� No difference in MACE, or the individual components of MACE, were observed at 3 year
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Statistical Assumptions
� Steering Committee E. H. Christiansen (PI) L. O. Jensen P. Thayssen H. H. Tilsted J. Ravkilde J. F. Lassen � Clinical Event Committee
K. Thygesen J. T. Soerensen B. L. Noergaard
� DSMB
M. Madsen H. T. Soerensen
� Coordinating Center Aarhus University Hospital, Skejby, Aarhus, Denmark
� Participating centers Aarhus University Hospital, Skejby Aalborg University Hospital Odense University Hospital
SORT OUT Study Organization