Kháng tiểu cầu kép sau can thiệp mạch vành qua da bao lâu là đủ
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Kháng tiểu cầu kép
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Bao lâu là đủ ?
TS. Nguyễn Cửu Lợi
Trung tâm Tim mạch Huế
Late in-stent thrombosis Eur Heart J. 2000;21:2033-2041
Eur Heart J. 2004;25:720-722 Assess the effect of DAPT 6 vs 24months on longterm outcomes
Randomized, multicenters
All corners with BMS, ZES, PES, EES A Pooled Analysis of
the REAL-LATE and the ZEST-LATE Trial
Seung-Jung Park, MD, PhD,
University of Ulsan College of Medicine, Asan Medical Center
on behalf of the REAL-LATE and the ZEST-LATE trial
Duration of Dual Antiplatelet
Therapy After Drug-Eluting Stent
Implantation (2010)
No. at Risk
Continuation group 1357 1122 299
Discontinuation group 1344 1100 301
Log-rank, P=0.17
Primary End Point: cardiac death or myocardial infarction
Clopidogrel
continuation
Clopidogrel
discontinuation
0.5
0.7
1.2
1.8
No. at Risk
Continuation group 1357 1119 295
Discontinuation group 1344 1097 300
Log-rank, P=0.048
Death, Myocardial Infarction, or Stroke
Clopidogrel
continuation
Clopidogrel
discontinuation
1.1
1.1
1.8
3.2
No. at Risk
Continuation group 1357 1124 301
Discontinuation group 1344 1102 303
Log-rank, P=0.76
Definite Stent Thrombosis
Clopidogrel
continuation
Clopidogrel
discontinuation
0.1
0.2
0.4
0.4
Certain DES:
Resolute (ZES)
Clinical outcomes at 12 and 24 months
Hx Controls
Performance Goals
Resolute stent
2.25–3.5 Clinical (n=1242)
2.25–3.5 Angio/IVUS (n=100)
4.0 Angio (n=60)
38mm Clinical (n=110–175)
RESOLUTE US
PI: M. Leon, L. Mauri, A. Yeung
Primary Endpoints:
• 2.25–3.5 Clinical → Target Lesion Failure at 12mo
• 2.25–3.5 Angio/IVUS → In-Stent LLL at 8mo
• 4.0 Angio → In-Segment LLL at 8mo
• 38 mm Clinical → Target Lesion Failure at 12mo
Drug Therapy: ASA and clopidogrel/ticlopidine ≥ 6mo (per guidelines)
De Novo Native Coronary Lesion
Vessel Diameter: 2.25 – 4.2 mm
Lesion Length: ≤ 27 mm
(≤ 35 mm lesions tx w/ 38 mm stent)
Clinical endpoints
Angio/IVUS endpoints
6mo 4yr 3yr 2yr 12mo 18mo 8mo 5yr 9mo 30d
N = max 1577 patients
Up to 135 US sites
Clinical Study Design
Mauri L, et al. Am Heart J. 2011;161:807-14.
% (n)
30 Days
n=1399
1 Year
n=1386
2 Year
n=1359
Stent thrombosis
(ARC def/prob)
0.1 (1) 0.1 (2) 0.2 (3)
Early (< 30 days) 0.1 (1) 0.1 (1) 0.1 (1)
Late (30-360 days) n/a 0.1 (1) 0.1 (1)
Very Late (>360 days) n/a n/a 0.1 (1)
RESOLUTE US – All Patients
Stent Thrombosis at 24 Months
OPTIMIZE:
A Prospective, Randomized Trial
of 3 Months Versus 12 Months
of Dual Antiplatelet Therapy with the
Endeavor Zotarolimus-Eluting Stent
• Fausto Feres, MD, PhD
• On behalf of the OPTIMIZE Trial Investigators
• Instituto Dante Pazzanese de Cardiologia
• São Paulo, Brazil
Primary Endpoint: NACCE at 1 Year
(All-Cause Death, MI, Stroke, Major Bleeding)
Month 0 1 3 6 12
No. at risk 1563 1520 1504 1468 1384
No. events 18 25 11 18 21
No. at risk 1556 1514 1497 1466 1381
No. events 16 25 11 16 22
Log-Rank P = 0.84
HR 1.03 (0.77 – 1.38)
Cumulative Incidence
of NACCE (%)
Time After Initial Procedure (Months)
0
12
0
10
15
5
3
6
9
6.0
5.8
12M DAPT
3M DAPT
Non-inferiority
P-value = 0.002
Stent Thrombosis vs. Bleeding
Month 0 1 3 6 12
No at risk 1563 1555 1540 1506 1505
No events 0 6 3 4 0
No at risk 1556 1541 1525 1501 1500
No events 5 3 3 1 0
Month 0 1 3 6 12
No at risk 1563 1538 1516 1482 1439
No events 4 15 10 4 2
No at risk 1556 1528 1501 1472 1387
No events 11 8 12 6 8
Any Bleeding
*
Time After Initial Procedure (months)
0.4
1.0
P = 0.07
HR 0.43 (0.16-1.11)
0
12
0
10
5
3
6
9
P = 0.78
HR 0.93
(0.56-1.54)
3M DAPT
12M DAPT
1.9
2.0
ARC Def./Prob. Stent Thrombosis
3M DAPT
12M DAPT
Time After Initial Procedure (months)
0.3
0.1
P = 0.18
HR 3.97 (0.44-35.49)
0
12
0
10
5
3
6
9
P = 0.64
HR 0.81
(0.34-1.96)
Incidence (%)
0.7
0.6
*Any bleeding according to the combined REPLACE-2 and GUSTO criteria.
Individualization of DAPT duration
