Transcript Kereiakes_DAPT - Clinical Trial Results

Dual Antiplatelet Therapy (DAPT) Duration
Dilemma: Recent Trials And Guidelines For
Clinical Practice
Dean J. Kereiakes, MD FACC FSCAI
Medical Director, The Christ Hospital Heart &
Vascular Center and the Lindner Research Center at
The Christ Hospital, Cincinnati, Ohio
Professor of Clinical Medicine, Ohio State University
Dean J. Kereiakes, MD – Disclosure Information
Consulting fees:
• Modest: Medpace, HCRI, Ablative
Solutions, Inc.
• Significant: Boston Scientific, Abbott
Vascular, REVA Medical Inc.
2011 ACC/AHA/SCAI Guideline for PCI
The duration of P2Y12 inhibitor therapy
should generally be as follows:
DURATION
I IIa IIb III
a.
In patients receiving a stent (BMS or DES)
during PCI for ACS, P2Y12 inhibitor therapy
should be given for at least 12 months. Options
include clopidogrel 75 mg daily,prasugrel 10 mg
daily or ticagrelor 90mg twice daily
I IIa IIb III
b. In patients receiving DES for non-ACS indication,
clopidogrel should be given for at least 12 months
if patients are not at high risk for bleeding.
I IIa IIb III
c. In patients receiving BMS for a non-ACS indication,
clopidogrel should be given for a minimum of 1
month and ideally up to 12 months (unless patient
is at increased risk for bleeding;then it should be
given for a minimum of 2 weeks) Circulation 2011;124:e574-651
3
Randomized Trials of DAPT Duration
Trial
Patients
Test
Randomization
1° EP
2701
DES
N=20,645
(15,245 DES)
(5,400 BMS)
N=1,800
DES, BMS
1 vs. 2 yrs
A vs. A+C
Superiority
A+P vs. DAPT
(clop or pras)
NI and Sup
A vs. A+C
Superiority
D/MI
2 yrs after rand
D/MI/TVR
Prolonged DAPT Studies
REAL/ZEST Late
DAPT
PRODIGY
1 vs. 2.5 yrs*
6 mos vs. 2 yrs
D/MI/CVA
ST, Bleeding
D/MI/CVA
Abbreviated DAPT Studies
EXCELLENT
ISAR-SAFE**
N=1,443
SES and EES
N=6,000
DES
6 vs. 12 mos*
A vs. A+C
Noninferiority
A+P vs. A+C
Noninferiority
N=3,700
EES
6 vs. 12 mos
A vs. A+C
Noninferiority
D/MI/CVA/
ST/TIMI MB
D/MI/CVA/
Urg
Revasc/MB
N=3,120
ZES
N=2,148
E-ZES vs RZES, SES, EES
3 vs. 12 mos
A vs. A+C
Noninferiority
D/MI/CVA/MB
3 vs. 12 mos
A+C vs. A+C
CVD/MI/ST/
ID-TVR, Bleed
ITALIC
OPTIMIZE
RESET‡
‡Strategy not DAPT duration
**2014-2015
6 vs. 12 mos
*Plus a 3 month washout period
Correlation of Clopidogrel Therapy Discontinuation in REAL-world Patients
Treated with Drug-Eluting Stent Implantation and Late Coronary Arterial
Thrombotic Events:
REAL-LATE Trial
Patients on current dual antiplatelet therapy without MACCE or major bleeding
for at least the first 12 months after DES implantation (Total N~2,700)
1:1 randomization Stratified by
(1) centers
(2) Initial DES types
Aspirin + clopidogrel
Dual-therapy
(N=1,000)
Aspirin Mono-therapy
(N=1,000)
Regular Clinical assessment after randomization
Primary end points: The composite of cardiac death or MI
PRODIGY Study: 6 vs 24m DAPT after DES or BMS,
randomized at 30 days
2,013 randomly allocated to recieve one of the four study stent types
499 randomized to
and received EES
498 randomized to
and received PES
500 randomized to
and received ZES
502 randomized to
and received BMS
(1497 DES)
694 Excluded, 353 Not Meeting
Inclusion Criteria
232 Refused to Participate, 109
Operator’s choice
1,970 DES and BMS
randomized at 30 days
983
BMS 30d
treatment
allowed and
counted as 6m
6 Months
DAPT
Ff
984
f
2 year follow-up
Not blinded
Primary EP
Death,MI,CVA
987
24 Months
DAPT
Ff
979
f
2 year follow-up
Valgimigli, M., et al., Circulation, 2012.
EXCELLENT Trial Design
Prospective, open label, two-arm, randomized multi-center trial
1372 Patients Matching
Enrollment Criteria
19 centers in Korea
Everolimus-Eluting Stent
N=1029
DAT 6 mo
DAT 12 mo
N=515
N=514
Randomization
3:1
Sirolimus-Eluting Stent
2x2
factorial design
DAT 6 mo
DAT 12 mo
N=171
N=172
N=343
Percutaneous Coronary Intervention
clinical endpoint
evaluation
Clinical
1mo
Angiographic
*CD,MI,IDTVR
3mo
9mo
12mo
Primary endpoint:
In-segment LL
TVF*
2yr
3yr
4yr
5yr
Am Heart J 2009 May;157:811-817.e1.
Gwon et al. Circ. 2012;125:505-513
7
OPTIMIZE STUDY
3,120 minimally selected* patients undergoing PCI
with E-ZES in 33 sites in Brazil
Randomization ** (1:1)
DAPT for 3 months
N = 1,560
DAPT for 12 months
N= 1,560
Clinical FU at 1, 3, 6, 12 and 18 months and yearly up to 3 yrs
Primary endpoint: Net Clinical Benefit † at 12-month FU
Feres et al. AHJ 2012:164:810 e3
Feres et al. TCT 2013 LBCT
* Exclude ACS with + biomarker; prior DES Rx;SVG target
** Stratified by DM and Institution; not blinded
† composite endpoint of all-cause death, MI, CVA and major bleeding
Ischemic Endpoints By DAPT Duration In Randomized Trials
EXCELLENT t
12
6 mos (n=957)
12 mos (n=970)
8.4
12 mos (n=1344)
24 mos (n=1357)
3 mos (n=1563)
12 mos (n=1556)
10 10.1
8.9
8.4
7.5
8
% Patients
OPTIMIZE tttt
REAL-LATE/
ZEST-LATE ttt
6 mos (n=1546)
24 mos (n=1500)
9.6
10
6
PRODIGY tt
7.5
4.7 4.4
4.6
4
4.1
3.2
1.7
2
2.3
1.8
0
TVF*
MACCE**
*Cardiac death / MI / TVR
**Death / MI, CVA, Revasc
***Death/MI/Revasc
D/MI
D/MI/CVA
D/MI
Adapted from
D/MI/CVA
Cardiac
MACE***
D/MI
t Gwon et al. ACC 2011
tt Valgimigli et al. ESC 2011
ttt Park et al. NEJM 2010;362:1374
tttt Feres et al. TCT 2013 LBCT
Major Bleeding (TIMI or GUSTO/REPLACE 2* )
By DAPT Duration In Randomized Trials
EXCELLENT t
3
2.5
6 mos
12 mos
PRODIGY tt
6 mos
24 mos
P=0.42
REAL-LATE/
ZEST-LATE ttt
12 mos
24 mos
P=0.04
OPTIMIZE tttt*
3 mos
12 mos
P=0.35
P=0.66
% Patients
2
1.6
1.5
1
0.6
0.5
0
0.3
0.7
0.6
0.1
Adapted from
0.8
0.2
t Gwon et al. ACC 2011
tt Valgimigli et al. ESC 2011
ttt Park et al. NEJM 2010;362:1374
tttt Feres et al. TCT 2013 LBCT
Type II, III or V BARC Bleeding: PRODIGY
CEC adjudicated
24 mo DAPT
6 mo DAPT
P=0.00018
%
7.4
3.5
Hazard ratio: 0.46 (0.1-0.69)
0
0
180
360
540
720
No. at Risk
24-month clopidogrel
987
925
884
6-month clopidogrel
983
919
881
Valgimigli et al. Circulation 2012; 125:2015-2026
PRODIGY BARC Bleeding Categories
10
24 mo DAPT
6 mo DAPT
8
%
6
4
P=0.001
P=0.075
4.0
P=0.029
2.5
2
1.5
1.4
0.9
0.5
0
BARC 2*
BARC 3
BARC 5
*BARC 2 “Any overt, actionable sign of hemorrhage that…meets at least one of
the following criteria: (1) requiring nonsurgical, medical intervention by a
healthcare professional, (2) leading to hospitalization or increased level of care, or
(3) prompting evaluation…no change in hemoglobin, blood transfusion or
hemodynamic sequelae are required”
Mehran et al. Circ 2011;123:2736-2747
OPTIMIZE : NACCE at 1 Year
(All-Cause Death, MI, Stroke, Major Bleeding)
Cumulative Incidence
of NACCE (%)
15
3M DAPT
12M DAPT
Log-Rank P = 0.838
10
6.0
5.8
5
0
0
3
6
9
Time After Initial Procedure (Months)
12
No. at risk
3M DAPT
12M DAPT
1563
1556
1520
1514
1504
1497
1468
1466
1384
1381
Feres et al. TCT 2013 LBCT
Primary Endpoint: NACCE at 1 Year
(All-Cause Death, MI, Stroke, Major Bleeding)
3M DAPT
12M DAPT
(N = 1563)
(N = 1556)
6.1%
5.9%
Difference
Upper 1-sided 95% CI
: 0.2%
Non-inferiority
P value
: 2.0%
=
0.002
Zone of non-inferiority
Pre-specified margin = 2.7%
Non-inferior
-1.0
-0.5
0.0
0.5
1.0
1.5
2.0
2.5
3.0
3.5
4.0 %
Upper one-sided 95% CI
Primary Non-Inferiority Endpoint Met
OPTIMIZE :Other Clinical Events at 1 Year*
3 Months DAPT (N = 1563)
Bleeding
/ Safety
Ischemic / Efficacy
12
10
12 Months DAPT (N = 1556)
12%
8.4
Events (%)
8
7.5
12%
6
14%
4
3.2
4.6
9.4%
4.1
2.8
3.5 3.2
2
12.5%
0.7 0.8
0
MACE
MI
*All P=NS
Cardiac
Death/MI
TLR
Major Bleed
Feres et al. TCT 2013 LBCT
OPTIMIZE: Stent Thrombosis* vs. Major Bleeding
Major Bleeding
ARC Def./Prob. Stent Thrombosis
Cumulative Incidence (%)
3M DAPT
12M DAPT
P = 0.64
HR 0.81
(0.34-1.96)
5
P = 0.18
HR 3.97
(0.44-35.49)
~4x
0
0.7
0.6
0
3
6
9
0.26
0.07
Cumulative Incidence (%)
10
10
12
Time After Initial Procedure (months)
*0.2% absolute difference
3M DAPT
12M DAPT
5
P = 0.79
HR 0.87
(0.32-2.40)
P = 0.31
HR 0.50
(0.12-1.99)
2x
0
0
3
6
0.4
0.2
9
Time After Initial Procedure (months)
Feres et al. TCT 2013 LBCT
12
RESET
2,148 patients enrolled and randomized
Divided into 4 subsets and 1:1 randomization
was performed
E-ZES with 3-month DAPT
Standard Therapy
Other DES with 12-month DAPT
31 patients excluded
- 16 withdrawal of consent
- 15 Met exclusion criteria
E-ZES with 3-month DAPT (N=1059)
Diabetes mellitus
Subset (N=292)
E-ZES
(N=146)
R-ZES
(N=146)
Acute coronary syndrome
Subset (N=601)
E-ZES
(N=301)
R-ZES
(N=300)
Primary Endpoint:
CV death, MI, ST, ID-TVR, Bleed (TIMI major & minor)
Standard therapy (N=1058)
Short-length DES
Subset (N=681)
E-ZES
(N=341)
SES
(N=340)
Long-length DES
Subset (N=543)
E-ZES
(N=271)
EES
(N=272)
Kim et al. JACC 2012;60:1340-1348
RESET: Clinical Events Through 1 Year
E-ZES + 3 month DAPT (n=1,059)
5
4.7
4.7
Standard Therapy (n=1,058)
Adapted from Kim et al. JACC 2012 Sep 5 (e-Pub ahead of print)
% Patients
4
3
2
1.3
0.8
1
0
40
41
CV Death, MI, ST,
ID-TVR, Bleed*
8
0.6
11
Death, MI, ST
0.2
0.3
0.2
2
3
2
Def/Prob ST**
6
Major Bleed
*Primary Endpoint: (Assumed 10% with N.I. margin 4% for absolute difference in risk)
**SORT OUT III / ENDEAVOR IV / PROTECT / KAMIR
ISAR-SAFE
Study Flowchart
-8th
to
Drug- Eluting Stenting
-5th
Continuous Clopidogrel therapy for 5 to 8 months
Randomization
0
Clopidogrel 75 mg/d
for 6 months
Placebo
for 6 months
Follow Up
1st
6th
9th
1st FU: 1 month after randomization
2nd FU: 6 months after randomization (at least one day after
study drug cessation)
3rd FU: 9 months after randomization (at least 3 months after
study drug cessation)
PEP = death,MI,stent thrombosis,stroke,TIMI major bleed
DAPT: Study Design
Eligible for Enrollment after PCI
•Any PCI with DES or BMS
•>18 years of age
•No contradictions to dual antiplatelet therapy
•Able and willing to provide written informed consent
Not Eligible for
Randomization at 12 m
Eligible for Randomization at 12 m
Stratified by DES v BMS, drug type, and
complexity (ACS or lesion-based)
18
12 m DAPT
Arm
30 m DAPT
Arm
mos
Aspirin + blinded
placebo
Aspirin + blinded
thienopyridine
Study treatment period 12-30 m
Study observation period 30-33m
Total 33 month follow-up
• Death
• MI or repeat PCI at > 6 weeks
• CABG
• Stroke
• Major Bleed
Total 33 month follow-up
Primary analysis DES treated subjects, 12-30m
Secondary analysis propensity matched BMS to
DES subjects 0-30m
2 co-primary endpoints: stent thrombosis and
MACCE (death, myocardial infarction or stroke)
Powered safety endpoint: major bleeding (GUSTO)
Mauri, Kereiakes et al AHJ 2010;160:1038-1041
20
Thienopyridine Type: DAPT Study
All Randomized Subjects; N = 11,649
32
68
Clopidogrel
Prasugrel
Stent Type: DAPT Study
All Randomized Subjects
N = 11,649
DES
Type*
N = 9,961
14
86
DES
BMS
Cypher (n=1,196)
12.0%
Endeavor (n=1,310)
13.1%
TAXUS (n=2,786)
28.0%
Xience/PROMUS
(n=4,874)
48.9%
*Some patients received more than one DES type
Complexity Amongst Randomized Subjects: DAPT
*clinical =ACS, renal insufficiency LVEF <30%
**anatomic=UPLM; >3 vessels; >2 lesions/vessel; LL ≥30mm; bifurcation; DES ISR; SVG; thrombus; VBT
Cumulative incidence rate (%)
EXCELLENT Trial:
Target Vessel Failure
6-mo DAT
12-mo DAT
P=0.507
HR = 1.17 (95% CI 0.73-1.89)
4.7%
4.4%
Months after initial procedure
Patient Number at Risks
6-month
722
707
701
697
681
12-month
721
710
699
698
680
Am Heart J 2009 May;157:811-817.e1.
TVF According To Diabetes And DAPT Duration:
EXCELLENT
Non-diabetics
Diabetics
p=0.022
HR = 0.42 (95% CI 0.20-0.88)
6-mo DAT
12-mo DAT
p=0.005
8.8%
HR = 3.15 (95% CI 1.41-7.01)
5.2%
2.9%
2.2%
Patient Number at Risk
Patient Number at Risk
6-mo
450
446
445
443
437
272
261
259
255
245
12-mo
443
435
432
429
416
278
275
271
270
265
Gwon et al,ACC 2011 LBCT
6 vs. 12 months DAPT After DES: EXCELLENT
Total
6 mo
DAPT
n (%)
12 mo
DAPT
n (%)
HR (95% CI)
P
value
Interaction
P-value
Age <65
767
19 (5.1)
12 (3.2)
1.61 (0.78-3.31)
0.20
≥65
676
15 (4.5)
18 (5.5)
0.83 (0.42-1.65)
0.59
No
699
21 (6.03)
13 (3.82)
1.61 (0.8-3.21)
0.18
744
13 (3.65)
17 (4.69)
0.78 (0.38-1.60)
0.50
Diabetes No
893
10 (2.27)
22 (5.08)
0.44 (0.21-0.94)
0.03
Yes
550
24 (9.09)
8 (2.96)
3.16 (1.42-7.03)
0.005
LVEF ≥50%
1097
26 (4.91)
24 (4.42)
1.12 (0.64-1.95)
0.69
124
2 (3.08)
4 (7.41)
0.41 (0.07-2.23)
0.30
0.27
1079
25 (4.72)
26 (4.94)
0.96 (0.55-1.66)
0.89
0.18
364
9 (5.14)
4 (2.27)
2.31 (0.71-7.5)
0.16
ACS
Yes
<50%
Stent type
EES
SES
0.19
0.15
<0.001
0.125 0.25 0.5 1 2 4 8
Favors 6 mo DAPT
Favors 12 mo DAPT
Gwon et al. Circulation 2012;125:505-13
Clopidogrel Duration after PCI in Diabetics*:
Death and Non-Fatal Myocardial Infarction
< 6 months
6-9 months
Cumulative Incidence (%)
25
25
Composite of death & MI
p <0.001
20
Death
15
10
10
5
5
0
90
# at risk
< 6 mos 261
6- 9 mos 117
> 9 mos 371
180 270 360 450 540 630
Time (days)
234
113
358
222
106
356
174
83
286
*749 consecutive diabetic patients/Kaiser L.A.
p < 0.001
20
15
0
> 9 months
0
0
90
261
117
371
180
270 360 450
Time (days)
239
116
362
231
111
361
540
630
186
88
293
Brar et al. JACC 2008;51:2220
Stent Type and Clopidogrel Duration After PCI in Diabetics:
Death and Non-Fatal Myocardial Infarction
w/ clopidogrel
w/o clopidogrel
Cumulative Incidence (%)
20
w/ clopidogrel
w/o clopidogrel
10
15
BMS
DES
landmark-left censored
landmark-left censored
10
P=0.01
P=0.07
5
5
0
0
0
90
180 270 360 450 540 630
Time (days)
# at risk
BMS with clop 147
BMS w/o clop 74
145
67
139
64
0
90
# at risk
DES with clop
DES w/o clop
180
270 360 450
Time (days)
323
127
312
125
540
630
220
83
Brar et al. JACC 2008;51:2220
Multivariate Analysis Predictors of BARC Bleeding Events
on DAPT*
OR (95% CI)
Female
P
2.7 (1.8-4.1) <0.001
Non-diabetic
1.9 (1.2-3.1)
VLTPR (VASP≤10%)
0.005
4.7 (2.7-8.3) <0.001
-2
1
2
4
6
8
10
*1,542 patients (clopidogrel 1155; prasugrel 387)
Adapted from Cuissett et al. JACC Card Int 2013;6:854-863
Stent Thrombosis Stratified by Clinical Syndrome
and Stent Type
5
5
ACS vs SA logrank p<0.0001
4
3
4
BMS: SA vs. ACS logrank p=0.01
DES: SA vs. ACS logrank p=0.0007
SA: BMS vs. DES logrank p=0.2
ACS: BMS vs. DES logrank p=0.06
DES, ACS
3
ACS
BMS, ACS
2
2
DES, SA
1
BMS, SA
1
SA
0
0
0
6
12
18
24
Time (months)
N=5,816
30
36
0
6
12
18
24
30
Time (months)
Kukreja et al. JACC Intv 2009;2:534
36
Analysis of DAPT Duration Beyond 1 Year Following PCI for
AMI*: COREA-AMI Registry
% Patients Death, NFMI, Stroke
25.0
20.0
P<0.001 for trend
18.0
15.0
10.2
10.0
8.9
5.0
0.0
12-18 months
18-24 months
>24 months
*2293 consecutive patients MACCE + major bleed free at 1 year post-MI
Koh et al. JACC 2013;61:A40 (abstract E161; presentation 1255M-178)
Mortality Following PCI for ACS by Clopidogrel Use:
Veterans Administration 2003-2004*
Cumulative mortality rate
0.2
0.15
0.1
0.05
Off clopidogrel
On clopidogrel
0
0
90
180
270
360
450
540
630
720
Follow-up time, days
*n=1455 (66% BMS, 34% DES)
HR BMS 2.65; DES 2.0
Ho et al. Am Heart J 2007;154:846
Freedom from Cardiac Death, M I and Revasc
Target And Non-target Lesion MACE* After Stenting
In 1,057 Patients (Sirius Trial)
%
Target Vessel
100
100
90
90
80
72.3%
80
70
57.1%
70
60
50
Non-target Vessel
%
74.3%
74.2%
60
SES
BMS
Log-Rank p<0.001
40
SES
BMS
50
Log-Rank p=0.096
40
0 360 720
1080 1440 1880
Time after Initial Procedure (days)
*CV Death, M I, Revasc
0
360 720
1080 1440 1880
Time after Initial Procedure (days)
Chacko, Cutlip et al. JACC Intv 2009;2:498
CHARISMA: Dual Therapy Vs. ASA Monotherapy
In Symptomatic* Patients
CD / MI / Stroke
*Prior MI, CVA or symptomatic PAD
Bhatt et al. JACC 2007;49:1982-1988
Failure rate
Failure rate
Death / MI Events Following Clopidogrel
Discontinuation After SVG PCI
Sachdeva et al. JACC 2012; Oct 25 [Epub ahead of print]
Cumulative incidence of D / MI / CVA (%)
Stenting for ISR: PRODIGY Substudy
0.85
short DAPT regimen (n=114)
long DAPT regimen (n=110)
0.90
0.95
P=0.034
1.00
0 60 120 180
240
300 360 420 480 540 600 660 720
Time (days)
Campo et al. JACC 2013 prepub
Definite Stent Thrombosis Through 3 Years In 18,334 Patients
(28,739 Lesions) By Stent Type
3-Year Incidence of Stent Thrombosis
BMS
1G-DES
2G-DES
Stent Thrombosis (%)
Stent thrombosis (%)
3.0
2.5
2.0
1.5
1.0
1-Year Landmark Analysis
3.0
2.5
2.0
1.5
1.0
0.5
0.5
0.0
0.0
0
1
2
Years after procedure
3
BMS
1G-DES
2G-DES
0
1
2
Years after procedure
Tada, Kastrati et al. JACC INTV 2013; 6:1267-74
3
Clinical Outcomes By Statistical Model, Duration of DAPT And
Follow-Up: Meta Analysis of 13 RCCT Involving 17,097 Patients
TVR
Stent Thrombosis
MI
Statistical Model
Random (13)
Fixed (13)
Clopidogrel
Duration
6 months (5)
12 months (7)
Follow-up Duration
≤ 1 year (12)
> 1 year (7)
Favors
.1
EES
1
10
Non-EES
0.4
EES
4 0.4
Non-EES EES
Baber et al. JACC 2011;58:569-77
4
Non-EES
Long-term Risk Of Def/Prob Stent Thrombosis:
Network Meta-Analysis Of 76 RCCT*
Control
BMS (Ref)
Treatment
Treatment
Control
Odds Ratio
95%
CrI
Sirolimus
Paclitaxel
Everolimus
Zotarolimus
Zotarolimus-R
0.80
1.11
0.46
0.69
0.62
0.61
0.85
0.31
0.39
0.29
1.10
1.49
0.70
1.28
1.44
Paclitaxel
Everolimus
Zotarolimus
Zotarolimus-R
1.38
0.57
0.87
0.78
1.02
0.39
0.48
0.35
1.84
0.84
1.50
1.73
Everolimus
Zotarolimus
Zotarolimus-R
0.41
0.62
0.56
0.29
0.35
0.26
0.60
1.11
1.25
Zotarolimus
Zotarolimus-R
1.52
1.36
0.77
0.68
2.83
2.71
Zotarolimus-R
0.91
0.36
2.40
Sirolimus (Ref)
Paclitaxel (Ref)
Everolimus (Ref)
Zotarolimus (Ref)
0.10
1.0
* >86% probability that EES has lowest rate of “any” stent thrombosis
10.0
Bangalore et al. Circ 2012;125:2873-91
Network Meta-Analysis of 49 Trials Involving
50,844 Patients
Late definite or probable thrombosis
ds rtio (95% CI)
CoCr-EES vs BMS
0.42 (0.17-0.95)
CoCr-EES vs PES
0.33 (0.15-0.71)
CoCr-EES vs R-ZES
0.24 (0.05-0.94)
CoCr-EES vs E-ZES
0.19 (0.04-0.75)
SES vs PES
0.41 (0.17-0.90)
PC-ZES vs SES
4.31 (1.08-19.05)
0.01
0.1
Favors stent 1
1
10
100
Favors stent 2
Palmerini et al. Lancet 2012;379:1393-1402
DAPT Duration: Conclusions
1.
“One size shoe” approach for DAPT duration is unlikely to fit
all patients
•
•
•
ACS
Diabetes
CABG-SVG / ISR
We treat symptomatic patients and non-target lesions with
objective to reduce events (D/MI/CVA) which may not be
stent (target lesion) related
3. Stent platforms differ with respect to risk for early , late
and/or very late stent thrombosis events (“All DES not
created equal”)
4. Conclusions regarding “optimal” DAPT duration should be
based on adequately powered RCCT
2.
Stent Thrombosis and DAPT Interruption Through 2 Years:
Pooled Analysis of SPIRIT II-V; WOMEN; XV USA/India
Analysis population
11,219 / 13,259 (84.6%) pts complete DAPT data to 2 years
85 events in 83 pts (0.74%) through 2 years
45 ST events occurred in 44 pts with no
DAPT interruption from day 1 through 2 yrs
40 ST events occurred in 39 pts with some
DAPT interruption from day 1 though 2 yrs
45 events occurred “On” DAPT*
23 events occurred “On” DAPT
17 events occurred “Off” DAPT
►68/85 ST events (80.0%)
occurred “On” DAPT
*One patient did not receive loading lose and was off DAPT at ST event
(day 0) but started day 1 and never interrupted through 730 days.
Stone et al. JACC 2011;58(Suppl B):78