Post on 12-Aug-2020
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Randomized comparison of a sirolimus-eluting stent with a biolimus-eluting stent in patients treated with PCI: the SORT OUT VII trial
Lisette Okkels Jensen, Per Thayssen, Michael Maeng, Jan Ravkilde, Lars Krusell,
Hans-Henrik Tilsted, Anders Junker, Christian Juhl Terkelsen, Karsten Tange Veien,
Anne Kaltoft, Anton Boel Villadsen, Jens Aaroe, Klára Berencsi, Svend Eggert Jensen,
Knud Nørregaard Hansen, Steen Dalby Kristensen, Morten Madsen, Hans Erik Bøtker
Henrik Steen Hansen, Bent Raungaard, Jens Flensted Lassen, Evald Høj Christiansen
Odense University Hospital, Aarhus University Hospital, Aalborg University Hospital - DENMARK
Potential conflicts of interest
SORT OUT VII 1Y
Speaker's name: Lisette Okkels Jensen
I have the following potential conflicts of interest to report:
Honorarium:
ABBOTT VASCULAR, ASTRAZENECA, BIOTRONIK, ST. JUDE MEDICAL
Institutional grant/research support:
BIOSENSORS INTERNATIONAL, BIOTRONIK, ST. JUDE MEDICAL, TERUMO
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2015
Background
Drug-eluting stents have reduced the risk of in-stent restenosis.
Compared to first generation drug-eluting stents the second
generation with thinner stent struts have improved safety and
efficacy
Persistence of polymer material on first and second generation
drug-eluting stent after completion of drug release has been
suggested to be a trigger of a chronic inflammatory response
Third generation coronary drug-eluting stents with biodegradable
polymers have been designed to improve safety and efficacy
New ultra-thin strut third generation stents have been developed
and may further improve safety and efficacy
SORT OUT VII 1Y
Primary Endpoint
Objective:
To compare the efficacy and safety of the thin strut, cobalt-chromium
biodegradable polymer sirolimus-eluting Orsiro stent and the stainless
steel biodegradable polymer biolimus-eluting Nobori stent in an all-comer
population
Primary Endpoint:
Target lesion failure: a composite of cardiac death, myocardial infarction
(not related to other than index lesion) or target lesion revascularization
within 1 year
An event rate of 6.5% was assumed in each group. Sample size of 1.157
patients in each treatment arm, a one-sided 0.050 significance level and
a 90% power to detect non-inferiority. Non-inferiority margin of 3.0%
Clinically driven event detection based on Danish registries
SORT OUT VII 1Y
Patient Population Inclusion period: November 2012 to February 2014
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, ticagrelor, 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, treated
vessels or lesion length
SORT OUT VII 1Y
Patient Characteristics SIROLIMUS-ELUTING
ORSIRO STENT
BIOLIMUS-ELUTING
NOBORI STENT p
No. of patients 1261 1264
Age (years) 66.1 ± 10.7 64.8 ± 10.8 <0.01
Male gender 74.9 % 75.2 % 0.84
Diabetes 18.7 % 18.6 % 0.94
Hypertension 58.1 % 56.4 % 0.39
Current smoker 29.1 % 32.5 % 0.07
Prior CABG 8.0 % 7.6 % 0.72
Prior PCI 19.0 % 20.4 % 0.39
Prior myocardial infarction 17.4 % 17.8 % 0.83
Body mass Index (kg/m2) 27.5 ± 4.7 27.4 ± 4.4 0.63
Indication for PCI 0.47
Stable angina pectoris 44.3 % 43.9 %
NSTEMI / Unstable angina pectoris 30.7 % 32.6 %
STEMI 21.2 % 20.7 %
Other 3.7 % 2.8 %
Lesion Characteristics SIROLIMUS-ELUTING
ORSIRO STENT
BIOLIMUS-ELUTING
NOBORI STENT p
No. of lesions 1,590 1,588
No. of lesions per patient 1.26 1.26 0.71
Lesion type B2/C 56.6 56.2 0.67
Reference vessel size (mm) 3.2 ± 0.6 3.1 ± 0.5 0.02
Left main artery 1.1 % 0.8 % 0.46
Left anterior descending artery 43.1 % 42.3 %
Left circumflex artery 21.3 % 22.0 %
Right coronary artery 33.1 % 33.7 %
Saphenous vein graft 1.4 % 1.2 %
No. of stents Per patient 1.5 ± 0.8 1.5 ± 0.8 0.49
Per lesion 1.2 ± 0.5 1.2 ± 0.5 0.45
Total stent length (mm) Per patient 25.2 ± 15.5 25.6 ± 16.6 0.50
Per lesion 20.6 ± 11.0 20.9 ± 11.5 0.47
Direct stenting 14.5 % 13.7% 0.56
Stent delivery failure 1.6 % 2.1 % 0.36
1º Endpoint: Target Lesion Failure (Cardiac death, myocardial infarctionindex lesion related, target lesion revascularization)
Sirolimus-eluting stent
Everolimus-eluting stent
5.2%
4.9%
Sirolimus-eluting stent
Everolimus-eluting stent
5.2%
4.9%
1º Endpoint: Target Lesion Failure (Cardiac death, myocardial infarctionindex lesion related, target lesion revascularization)
12 months: ORSIRO 3.8% vs. NOBORI 4.6% Pnon-inferiority < 0.0001
ORSIRO
NOBORI
3.8%
4.6%
Sirolimus-eluting stent
Everolimus-eluting stent
5.2%
4.9%
Secondary Endpoints
Rate Ratio 0.89 95% CI 0.46-1.75; p=ns
Rate Ratio 0.65 95% CI 0.37-1.13; p=ns
Rate Ratio 0.68 95% CI 0.41-1.12; p=ns
Rate Ratio 0.79 95% CI 0.55-1.13; p=ns
1.3%
1.4%
1.6%
2.4%
2.0%
2.9%
4.1%
5.2%
Sirolimus-eluting stent
Everolimus-eluting stent
5.2%
4.9%
Stent Thrombosis
ORSIRO
NOBORI
0.9%
1.6%
ORSIRO
NOBORI
0.4%
1.2%
Rate Ratio 0.33 95% CI 0.12-0.92; p=0.03 Rate Ratio 0.55 95% CI 0.26-1.15; p=0.11
Target Lesion Failure
Acute coronary syndrom NO
Acute coronary syndrom YES
Age ≤ 65 years
Age > 65 years
Diabetes mellitus NO
Diabetes mellitus YES
LAD NO
LAD YES
Lesion type C NO
Lesion type C YES
Male NO
Male YES
Multi-vessel disease NO
Multi-vessel disease YES
One stent per patient NO
One stent per patient YES
Previous MI NO
Previous MI YES
Previous PCI NO
Previous PCI YES
STEMI NO
STEMI YES
All
21 (3.5)
27 (4.1)
15 (2.7)
33 (4.7)
37 (3.6)
11 (4.7)
22 (3.5)
26 (4.2)
26 (5.2)
22 (2.9)
13 (4.1)
35 (3.7)
39 (3.6)
9 (5.1)
25 (3.0)
23 (5.5)
36 (3.5)
12 (5.6)
38 (3.8)
10 (4.2)
31 (3.1)
17 (6.4)
48 (3.8)
29 (4.9)
29 (4.3)
28 (4.3)
30 (4.8)
42 (4.1)
16 (6.8)
32 (4.8)
26 (4.3)
33 (6.7)
25 (3.2)
15 (4.8)
43 (4.5)
52 (4.7)
6 (3.9)
39 (4.6)
19 (4.6)
43 (4.2)
13 (5.9)
42 (4.2)
15 (5.9)
46 (4.6)
12 (4.6)
58 (4.6)
0.70 (0.40 – 1.23)
0.96 (0.57 – 1.61)
0.60 (0.32 – 1.13)
0.99 (0.60 – 1.62)
0.88 (0.57 – 1.37)
0.68 (0.32 – 1.46)
0.71 (0.41 – 1.22)
0.97 (0.56 – 1.66)
0.77 (0.46 – 1.29)
0.89 (0.50 – 1.58)
0.86 (0.41 – 1.80)
0.82 (0.52 – 1.28)
0.77 (0.51 – 1.16)
1.32 (0.47 – 3.71)
0.65 (0.39 – 1.07)
1.19 (0.65 – 2.18)
0.84 (0.54 – 1.31)
0.97 (0.44 – 2.12)
0.90 (0.58 – 1.39)
0.71 (0.32 – 1.58)
0.68 (0.43 – 1.07)
1.38 (0.66 – 2.90)
0.83 (0.56 – 1.21)
0.43
-
0.23
-
0.56
-
0.43
-
0.71
-
0.92
-
0.34
-
0.13
-
0.77
-
0.61
-
0.10
-
-
Events (%) Hazard Ratio
SES BES 95% CI P
Favours SES Favours BES
In sub-groups
Conclusion
The thin strut biodegradable polymer sirolimus-eluting Orsiro stent
was non-inferior to the biodegradable polymer biolimus-eluting
Nobori stent in unselected patients for the combined safety and
efficacy endpoint target lesion failure at 1 year
The sirolimus-eluting Orsiro stent was associated with a reduced risk
of definite stent thrombosis
SORT OUT VII 1Y
SORT OUT VII 1Y