Ở bệnh nhân nguy cơ cao các cải tiến về công nghệ và thuốc có giúp các Stent phủ thuốc khác biệt nhau? - Võ Thành Nhân

Days after PCI 
Long term Safety Endpoint 
STENT THROMBOSIS @ 36 MONTHS 
OVERALL POPULATION HIGH-RISK SUBGROUPS 
2.3% 
0.0% 
ST
 (
%
) 
0.0 
10 
0 180 365 730 1095 
DIABETICS 
P=0.3437 
Days after PCI 
ST
 (
%
) 
0.0 
10 
0 180 365 
SMALL VESSELS 
P>0.9999 
0.0% 
730 1095 
Days after PCI 
COMPARABLE LONG-TERM EFFICACYAND SAFETY AS BEST-IN-CLASS NEWER GENERATION DP-DES 
IN AN OVERALL LOW-RISK PATIENT POPULATION AND IN HIGH-RISK SUBGROUPS 
Slagboom et al. Poster EuroPCR 2015, Paris, France 
Orsiro 
Xience 
Prime 
P 
Well-apposed 
struts 
98.6% 98.8% 0.62 
Incomplete Strut 
Apposition 
1.0% 0.6% 0.32 
Non-apposed side 
branch 
0.4% 0.6% 0.37 
Sum 100% 100% 
Covered Struts 98.3% 97.5% 0.042 
OCT results at 9 months 
Neointimal Area Apposition and Coverage 
0 
10 
20 
30 
40 
50 
60 
70 
80 
90 
100 
0.2 0.4 0.6 0.8 1 1.2 1.4 1.6 1.8 2 2.2 
Median of neo-intimal area (mm2) 
P
e
rc
e
n
t 
o
f 
le
s
io
n
s
 (
%
) 
Orsiro 
Xience Prime 
Mean value 
1.00± 0.44 mm2 
Mean value 
0.74± 0.38 
mm2 
P=0.024 
Source: S. Windecker, Late breaking trial presentation, EuroPCR 2013 
Orsiro has also shown superior strut 
coverage compared to Resolute Integrity 
• Orsiro v.s. Resolute Integrity (n=44, 1:1 randomization) 
• To access “early healing pattern of 2nd and 3rd 
generation DES” 
• Primary endpoint: Stent strut coverage at 3 months 
• Presented at EuroPCR 2013 by T. Kiviniemi, PI: P 
Karjalainen 
• No significant baseline differences between study arms 
• Most interesting result – Uncovered struts at 3 months 
Orsiro 3.9% vs. Resolute Integrity 8.9%, p<0.001 
• Conclusion 
“Sirolimus-eluting stents with bioabsorbable polymer 
were more completely covered compared to 
zotarolimus-eluting stents with durable polymer at 3 
months after PCI for ACS” 
HATTRICK-OCT study 
Published in Official Journal of the Japanese 
Circulation Society December 2014 
Clinical follow-up at 36 months 
Clinical follow-up at 6 months 
1’356 all-comers patients 
Clinical follow-up at 12 months* 
* 97.4 % FUP compliance 
Registry for an all-comers patient population 
with the limus eluting Orsiro stent system in 
daily clinical practice 
DESIGN 
An international, prospective, multi-center 
open-label, registry of the Orsiro hybrid DES 
in daily clinical practice 
OBJECTIVE 
Evaluate safety and clinical performance of the 
Orsiro drug eluting stent with a bioabsorbable 
polymer in a large patient population in standard 
clinical care 
COORDINATING INVESTIGATOR 
Prof. Dr. Johannes Waltenberger, 
Universitätsklinikum Münster, Germany 
PRIMARY ENDPOINT 
Target Lesion Failure (TLF) at 12 months 
NCT01553526 
Predefined subgroups 
Diabetic patients 
Acute MI (STEMI and NSTEMI) 
 Small vessels (≤2.75 mm) 
 Chronic Total Occlusion 
Clinical follow-up at 60 months 
Source: Waltenberger et al. EuroIntervention 2015; 10-online publish-ahead-of-print March 2015. 
 . 
DEFINITE STENT THROMBOSIS @ 12 MONTHS TARGET LESION FAILURE @ 12 MONTHS 
LOW TLF AND ST RATES IN AN UNSELECTED, ALL-COMERS POPULATION 
WITH COMPLEX CORONARY ARTERY DISEASE 
Primary Efficacy and Safety Endpoints 
Waltenberger J, Eurointervention 2015 
Days since index procedure 
12 
11 
10 
9 
8 
7 
6 
5 
4 
3 
2 
1 
0 
0 60 120 180 240 300 360 420 480 540 600 660 730 
10.5% - BP SES 
10.4% - DP EES 
TL
F 
(%
) 
6.7% - DP EES 
6.7% - BP SES 
PRIMARY ENDPOINT TLF @ 1 YEAR 
P NON INFERIORITY = 0.0004 
RR (95%CI)=1.00 (0.77-1.31) 
P= 0.98 
ULTRATHIN-STRUT BP-SES vs. THIN-STRUT DP-EES @ 2 YEARS (N=2’119) 
Primary Efficacy Composite Endpoint 
Zbinden R, J APimlgrHimea 
ULTRATHIN-STRUT BP-SES vs. THIN-STRUT DP-EES @ 2 YEARS (N=2’119) 
Composites of Primary Efficacy Endpoint 
C
ar
d
ia
c 
d
e
at
h
 (
%
) 
DP-EES 1056 1036 1033 1030 1030 1022 1014 992 989 988 986 985 979 
BP-SES 1063 1036 1031 1026 1022 1014 1007 988 984 976 974 971 960 
Number at risk 
8 
7 RR (95%CI)=1.01 (0.62-1.63), P=0.98 
6 
5 
4 
3 
2 
1 
0 
0 60 120 180 240 300 360 420 480 540 600 660 730 
Days since index procedure 
3.2% - DP EES 
3.2% - BP SES 
RR (95%CI)=0.91 (0.60-1.39), P=0.67 
Ta
rg
e
t 
ve
ss
e
l M
I (
%
) 
DP-EES 1056 1013 1009 1004 1000 990 981 959 955 953 948 944 937 
BP-SES 1063 1017 1011 1002 995 987 979 957 949 941 936 933 922 
Number at risk 
8 
7 
6 
5 
4 
3 
2 
1 
0 
0 60 120 180 240 300 360 420 480 540 600 660 730 
Days since index procedure 
4.1% - BP SES 
4.5% - DP EES 
8 
7 
6 
5 
4 
3 
2 
1 
0 
TL
R
 c
lin
ic
al
ly
 d
ri
ve
n
 (
%
) 
DP-EES 1056 1028 1023 1019 1013 1000 990 965 961 955 948 941 931 
BP-SES 1063 1027 1017 1005 992 983 974 950 944 934 929 925 908 
Number at risk 
0 60 120 180 240 300 360 420 480 540 600 660 730 
Days since index procedure 
6.0% - BP SES 
5.1% - DP EES 
RR (95%CI)=1.17 (0.81-1.71), P=0.40 
11 
10 
9 
8 
7 
6 
5 
4 
3 
2 
1 
0 
TL
F 
(%
) 
935 929 924 917 907 
928 918 911 908 889 
DP-EES 1056 1007 1001 996 988 975 965 940 
BP-SES 1063 1012 1002 989 975 967 958 935 
Number at risk 
600 660 730 0 60 120 180 240 300 360 420 480 540 
Days since index procedure 
10.4% - DP EES 
10.5% - BP SES RR (95%CI)=1.00 (0.77-1.31), P=0.98 
Zbinden R, J Am Heart Assoc. 2016 
Subgroup Analysis 
Primary Efficacy Composite Endpoint 
ULTRATHIN-STRUT BP-SES vs. THIN-STRUT DP-EES @ 2 YEARS (N=2’119) 
TARGET LESION FAILURE ACROSS PRESPECIFIED SUBGROUPS 
STRONG SIGNAL TOWARDS A SIGNIFICANT REDUCTION IN TLF 
IN THE PRESPECIFIED SUBGROUP OF PATIENTS WITH STEMI 
Zbinden R, J Am Heart Assoc. 2016 
BIOSCIENCE: STEMI Subgroup 
Primary Efficacy Composite Endpoint 
ULTRATHIN-STRUT BP-SES vs. THIN-STRUT DP-EES (N=407) 
TARGET LESION FAILURE @ 1 YEAR 
62% RRR 
5.4% ARR 
Pilgrim T, Eurointervention 2015 
BIOSCIENCE: STEMI Subgroup 
Primary Efficacy Composite Endpoint 
ULTRATHIN-STRUT BP-SES vs. THIN-STRUT DP-EES (N=407) 
TARGET LESION FAILURE @ 2 YEARS 
DP-DES - 10.8% 
DP-DES - 8.8% 
BP-DES - 5.4% 
BP-DES - 3.4% 
Piccolo R, JACC Cardiovasc Intv., 2016 
Newer-Generation BP-DES vs. DP-DES in STEMI 
BIOSTEMI 
ClinicalTrials.gov Identifier NCT02579031 
30-day clinical follow-up 
2,525 Patients across 3 centers in 
Denmark 
12-month clinical follow-up 
Orsiro 
n = 1,261 
1:1 randomization 
5 year clinical follow-up 
Source: Presentation, Lisette Okkels Jensen, EuroPCR 2015 
Randomized Comparison of a Sirolimus Eluting Orsiro 
Stent With a Biolimus-eluting Nobori Stent in 
Patients Treated With PCI 
Nobori 
n = 1,264 
DESIGN 
Randomized, multicenter, all-comer, two-arm, 
non-inferiority trial 
OBJECTIVE 
To compare the safety and efficacy of the 
sirolimus eluting Orsiro stent and the 
biolimus-eluting Nobori stent in a population-
based setting, using registry detection of 
clinically driven events 
PRINCIPAL INVESTIGATORS 
Per Thayssen, Odense, Denmark 
Lisette Okkels Jensen, Odense, Denmark 
PRIMARY ENDPOINT 
Target Lesion Failure (TLF) - composite of 
cardiac death, myocardial infarction (not 
index procedure related) not related to other 
than index lesion or TLR) at 12 months 
NCT01879358 
SORT OUT VII 
ULTRATHIN-STRUT BP-SES vs. THICK-STRUT BP-BES @ 12 MONTHS (N=2’525) 
TARGET LESION FAILURE DEFINITE STENT THROMBOSIS 
RR 0.83; 95% CI 0.56-1.21; p for non inferiority <0.0001 RR 0.33; 95% CI 0.12-0.92 p=0.03 
IMPROVED SHORT-TERM EFFICACY AND SAFETY COMPARED TO FIRST-GENERATION BP-DES 
IN ALL-COMERS PATIENTS WITH COMPLEX PATIENT AND LESION CHARACTERISTICS 
Primary Efficacy and Safety Endpoints 
Jensen LO. EuroPCR 2015, Paris, France 
SORT OUT VII 
Orsiro showed lowest definite stent thrombosis 
from SCAAR* registry 
Definite stent thrombosis, SCAAR registry, 2007- Apr 2016, Orsiro N=6,969) 
Orsiro: 
• One of low ST events DES 
• Lowest ST rate at 3-year 
*Swedish Coronary Angiography and Angioplasty Registry 
In addition, Orsiro showed lowest restenosis rate 
from SCAAR* registry 
Restenosis rate, SCAAR Registry, 2007- Apr 2016, Orsiro N=6,969) 
Orsiro: 
lowest restenosis rate 
among major DES brands 
at 3-year 
*Swedish Coronary Angiography and Angioplasty Registry 
6,5 
5,1 
6,5 
3,8 
4,4 
6,7 
4,2 
5,2 
4,6 
2,0 
4,0 
6,0 
8,0 
10,0 
12,0 
14,0 
RATES OF TARGET LESION FAILURE (%) @ 9-12 MONTHS 
Newer-Generation Biodegradable Polymer DES 
Clinical Performance: EFFICACY 
THIN-STRUT BP-DES THICK-STRUT BP-DES 
452 1‘356 2‘119 2‘525 1‘101 1‘684 3‘235 2‘707 2‘525 
ORSIRO SES EES BES SES 
0,0 
BIOFLOW-II BIOFLOW-III BIOSCIENCE SORT-OUT VII CENTURY II EVOLVE II NEXT COMPARE II SORT-OUT VII 
N = 
TARGET LESION FAILURE @ 9-12 MONTHS 
ORSIRO® HYBRID DRUG-ELUTING STENT 
HIGH-RISK SUBGROUPS 
LOW TLF RATES IN HIGH-RISK SUBGROUPS, SIMILAR TO RATES IN LOW-RISK PATIENTS 
Iglesias JF, Minerva Cardioangiologica 2015 
Foin, Oral Presentation, EuroPCR 2015 Foin, Oral Presentation, EuroPCR 2015 
Impact of strut thickness 
Shear stress and healing 
CONCLUSIONS 
The ultrathin-strut biodegradable polymer sirolimus-eluting stent: 
– comparable long-term clinical performance to the current state-of-the-
art newer- generation thin-strut durable polymer Xience everolimus-
eluting stent in broadly inclusive patient populations. 
– despite the lack of randomized data, low rates of TLF and ST in high-risk 
subgroups of patients with increased risk of cardiovascular events (diabetes 
mellitus, small vessels, long lesions, complex coronary lesions, multivessel 
disease, chronic total occlusion, or STEMI) similar to rates in lower-risk 
patients. 
– potential clinical superiority of the Orsiro SES over the best-in-class newer-
generation durable polymer Xience everolimus-eluting stent in the subgroup of 
patients with STEMI warrants confirmation in the ongoing BIOSTEMI 
randomized controlled trial. 
 Thank You for your attention!