Orsiro - Stent phủ thuốc thế hệ mới kết hợp công nghệ Hybrid - Nguyễn Quốc Thái

 - Nobori 
0.9 % - Orsiro 
DEFINITE STENT THROMBOSIS DEFINITE OR PROBABLE STENT THROMBOSIS 
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 
Source: Presentation, Lisette Okkels Jensen, EuroPCR 2015 
SORT OUT VII 
46 
Orsiro physician presentation, Sep 2015 
Target Lesion Failure trong các 
phân nhóm phụ 
Source: Presentation, Lisette Okkels Jensen, EuroPCR 2015 
SORT OUT VII 
47 
Orsiro physician presentation, Sep 2015 
Kết luận 
 Stent Orsiro với thiết kế khung stent mỏng, lớp polymer tự tiêu tẩm 
thuốc sirolimus không thua kém stent Nobori với lớp polymer tự tiêu 
tẩm thuốc biolimus trong dân số bệnh nhân không chọn lọc cho thấy 
tiêu chí gộp an toàn và hiệu quả sau sau 1 năm theo dõi 
 Stent Orsiro phủ thuốc Sirolimus liên quan đến giảm nguy cơ definite 
stent thrombosis so với stent Nobori 
Source: Presentation, Lisette Okkels Jensen, EuroPCR 2015 
SORT OUT VII 
48 
Orsiro physician presentation, Sep 2015 
Orient Trial 
372 patients randomized in 
 South Korea 
Angiographic follow-up at 9-month 
Orsiro 
n = 250 
2:1 randomization 
Clinical follow-up at 12-month 
Resolute Integrity 
n = 122 
DESIGN 
A prospective, randomized, multi-center, 
controlled trial comparing the Orsiro DES to 
Resolute Integrity 
OBJECTIVE 
To compare the Orsiro DES with a bioabsorbable 
polymer to the Resolute Integrity DES with a 
durable polymer. 
PRINCIPAL INVESTIGATORS 
Prof. Tae-Jin Youn, Seoul National University 
Bundang Hospital, South Korea 
PRIMARY ENDPOINT 
In-stent Late Lumen Loss at 9 months 
SECONDARY ENDPOINTS 
 TLF defined as composite of cardiac death,TLR 
and target vessel-related MI 
All-cause and cardiac deaths 
Clinically-driven TLR 
MI (target or non-target vessel-related) 
Definite or probable stent thrombosis (ST) 
ORIENT 
Source: EuroPCR2016, Kan_Si-Hyuck_20160517_1345_Room_Maillot 
49 
Orsiro physician presentation, Sep 2015 
Endpoints 
Primary Endpoint 
 In-stent LLL at 9 months 
Secondary angiographic Endpoints 
 In-segment LLL at 9 months 
 diameter stenosis (%) 
 Binary restenosis 
Secondary clinical endpoints 
 all-cause and cardiac deaths 
 clinically driven TLR and TVR 
 MI (target or non-target vessel-related) 
 definite or probable ST 
 TLF: cardiac death, TLR and target vessel-related MI 
ORIENT 
50 
Orsiro physician presentation, Sep 2015 
Tiêu chuẩn chọn bệnh / Loại trừ 
Tiêu chuẩn nhận vào 
 Patient age ≥18 years 
 Ability to acknowledge verbally the 
risks, benefits and treatment 
ramifications in receiving the Orsiro 
Hybrid® or Resolute Integrity® stent 
 Written informed consent given by 
legally authorized agent prior to any 
study-related procedure 
 Indication for use of drug-eluting stent 
based on ACC/AHA/SCAI and 
ESC/EACTS guidelines and/or clinical 
judgment of interventional cardiologist. 
 Target lesion(s) in coronary artery or 
graft vessel with estimated reference 
diameter ≥2.5 mm and ≤5.0 mm 
 Target lesion(s) amenable to 
percutaneous coronary intervention 
Tiêu chuẩn loại trừ 
• Known hypersensitivity or contraindication to any of the 
following agents: heparin, aspirin, clopidogrel, sirolimus, 
zotarolimus, cobalt chromium or contrast mediaa 
• Inability to tolerate aspirin or clopidogrel for 1-year 
duration of study 
• Systemic (intravenous) use of sirolimus or zotarolimus 
within 12 months 
• Females with childbearing potential (unless negative by a 
recent pregnancy test) or anticipating pregnancy 
following study enrollment 
• History of bleeding diathesis, known coagulopathy 
(including heparin-induced thrombocytopenia), or refusal 
of blood transfusions 
• Gastrointestinal or genitourinary bleeding within prior 3 
months, or major surgery within 2 months 
• Planned major non-cardiac surgery within designated 
study period 
• Cardiogenic shock (Killip class IV) 
• Symptomatic heart failure, precluding coronary 
angiography in a supine position 
• Non-cardiac co-morbid conditions limiting life expectancy 
(to <1 year) or potentially undermining protocol 
compliance (as judged by the site investigator) 
• Active participation in another drug- or device-related 
investigational study where the primary endpoint follow-
up is ongoing 
• Unwillingness or inability to comply with protocol 
procedures 
ORIENT 
51 
Orsiro physician presentation, Sep 2015 
Lưu đồ bệnh nhân 
372 patients and randomized 
250 allocated to 
Orsiro 
122 allocated to 
Resolute Integrity 
382 patients screened/randomized between xxx 
9 withdrew consent 
1 met clinical exclusion criteria 
180 analysed for primary endpoint 77 analysed for primary endpoint 
Source: EuroPCR2016, Kan_Si-Hyuck_20160517_1345_Room_Maillot 
ORIENT 
2 lost to follow up 
0 died 
43 refused follow-up angiography 
0 lost to follow up 
2 died 
68 refused follow-up angiography 
52 
Orsiro physician presentation, Sep 2015 
Đặc điểm lâm sàng ban đầu của BN 
Age (years) 65.2±11.9 64.8±11.0 
Male gender — n (%) 180 (72) 86 (70.5) 
Diabetes— n (%) 63 (25.2) 33 (27) 
Hypertension — n (%) 162 (64.8) 81 (66.4) 
Body Mass Index— (kg/mm^2) 24.8±3.5 24.5±3.1 
Previous PCI — n (%) 34 (13.6) 18 (14.8) 
Previous CABG — n (%) 2 (0.8) 0 (0.0) 
Chronic Renal Failure — n (%) 7 (2.8) 3 (2.5) 
Indication — n (%) 
 Stable Angina 136 (53.3) 70 (55.1) 
 Unstable Angina 62 (24.3) 25 (19.7) 
 ST-segment elevation MI (STEMI) 24 (9.4) 11 (8.7) 
 NSTEMI 33 (12.9) 21 (8.7) 
Orsiro 
(n=250) 
Resolute 
Integrity 
(n=122) 
Source: EuroPCR2016, Kan_Si-Hyuck_20160517_1345_Room_Maillot 
ORIENT 
53 
Orsiro physician presentation, Sep 2015 
Đặc điểm tổn thương ban đầu 
Lesion location 
 Left main artery — n (%) 20 (5.8) 5 (2.8) 
 Left anterior descending artery — n (%) 158 (45.8) 85 (48.3) 
 Left circumflex artery — n (%) 93 (27.0) 36 (20.5) 
 Right coronary artery — n (%) 74 (21.4) 50 (28.4) 
Lesion Classification 
 A — n (%) 15 (4.3) 10 (5.7) 
 B1 — n (%) 75 (21.7) 33 (18.8) 
 B2 — n (%) 108 (31.3) 52 (29.5) 
 C — n (%) 147 (42.6) 81 (46.0) 
Chronic total occlusion — n (%) 31 (9.0) 11 (6.3) 
Ostial lesion — n (%) 24 (7.0) 9 (5.1) 
Bifurcation lesion — n (%) 79 (22.9) 42 (23.9) 
Restenotic lesion — n (%) 4 (1.2) 4 (2.3) 
Calcification — n (%) 38 (11.0) 22 (12.5) 
Orsiro 
(n=250) 
Resolute 
Integrity 
(n=122) 
ORIENT 
Source: EuroPCR2016, Kan_Si-Hyuck_20160517_1345_Room_Maillot 
54 
Orsiro physician presentation, Sep 2015 
Procedural characteristics 
Stent number (per lesion) 1.14±0.43 1.13±0.43 
Stent number (per patient) 1.58±0.90 1.63±0.85 
Stent diameter - mm 2.98±0.46 3.00±0.45 
Stent length (per lesion) - mm 26.1±12.8 27.3±14.9 
Stent length (per patient) - mm 36.1±22.5 39.3±24.2 
Performance of adjunctive ballooning — n (%) 257 (74.5) 124 (70.5) 
 Nominal diameter – mm 3.03±0.51 2.98±0.49 
 Balloon pressure – atm 16.5±7.6 15.6±4.0 
 Expected balloon diameter - mm 3.34±1.01 3.33±1.43 
IVUS or OCT — n (%) 71 (20.6) 34 (19.3) 
Bifurcation stenting — n (%) 60 (17.4) 30 (17.0) 
Device success (per lesion) — n (%) 343 (99.4) 174 (98.9) 
Procedureal success (per patient) — n (%) 249 (99.6) 121 (99.2) 
Orsiro 
(n=250) 
Resolute 
Integrity 
(n=122) 
ORIENT 
Source: EuroPCR2016, Kan_Si-Hyuck_20160517_1345_Room_Maillot 
55 
Orsiro physician presentation, Sep 2015 
Primary endpoint 
In-stent Late Lumen Loss at 9 months 
ORIENT 
In-stent LLL [mm] 
Source: EuroPCR2016, Kan_Si-Hyuck_20160517_1345_Room_Maillot 
56 
Orsiro physician presentation, Sep 2015 
Secondary endpoint 
Target Lesion Failure at 12-month 
ORIENT 
Source: EuroPCR2016, Kan_Si-Hyuck_20160517_1345_Room_Maillot 
57 
Orsiro physician presentation, Sep 2015 
Kết luận 
 Orsiro demonstrated non-inferiority to Resolute Integrity in terms 
of in stent Late Lumen Loss (LLL) at 9 month. 
(Orsiro 0.10 ± 0.35 mm, Resolute Integrity 0.16 ± 0.39 mm, p for non-inferiority <0.001) 
 Orsiro showed numerically better results for the secondary clinical 
endpoint, target lesion failure (TLF) out to 12 months. 
(Orsiro 2.4 %, Resolute Integrity 3.3 %, p = 0.0623) 
 Results reconfirm those of previous Orsiro trials and adds to the 
solid foundation of clinical evidence that supports the use of 
Orsiro across a broad range of indications 
ORIENT 
58 
Orsiro physician presentation, Sep 2015 
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 
Synergy: 
• unlike their claims from 
EVOLVE-II, stent 
thrombosis event rate keeps 
increasing with Synergy 
• It does not even have longer 
follow up 
results yet 
*Swedish Coronary Angiography and Angioplasty Registry 
59 
Orsiro physician presentation, Sep 2015 
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 
Synergy: 
Synergy is lack of long-
term data 
*Swedish Coronary Angiography and Angioplasty Registry 
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Orsiro physician presentation, Sep 2015 
61 
Orsiro physician presentation, Sep 2015 
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Orsiro physician presentation, Sep 2015 
Thông điệp chính của các nghiên cứu lâm 
sàng về Orsiro là gì? 
 Ultrathin Orsiro chứng minh là một trong những stent phủ thuốc tốt 
nhất 
 Trong n/c BIOSCIENCE, là n/c ngẫu nhiên, tất cả các BN, được đề 
xuất bởi các nhà nghiên cứu, Orsiro đã chứng minh không thua kém 
Xience Prime về tiêu chí chính sau 12 tháng 
 N/c SORT OUT VII xác nhận lại bằng chứng của n/c BIOSCIENCE 
trong dân số tất cả các BN tham gia, cũng chứng minh tỷ lệ thấp 
đáng kể definite ST so với Nobori 
 Orient bổ sung thêm bằng chứng Orsiro không thua kém DES quan 
trong khác - Resolute Integrity của Medtronic