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1. 1
ESC 2017 UPDATE ON PATIENTS WITH
ATRIAL FIBRILLATION UNDERGOING
PERCUTANEOUS CORONARY INTERVENTION
Dinh Duc Huy, MD, FSCAI

2. Major bleeding was associated with a significant increase in
in-hospital mortality, regardless of bleeding site
2
Chhatriwalla et al. JAMA 2013
1.87%
in-hospital
mortality rate:
non-bleeding
5.26%
in-hospital mortality rate:
major bleeding
risk difference = 3.39%
(95% CI: 3.20–3.59)
P<0.001
Antithrombotic therapy that minimizes the risk of bleeding complications therefore
might be expected to result in better short- and long-term clinical outcomes after PCI
Cath-PCI registry, 3.3 million PCI procedures (2004–11):
Bleeding is the most common non-cardiac complication of PCI

3. AF and
ACS/PCI
Lip et al. Eur Heart J 2014;35:3155-3179
ACS/PCIAF
Anticoagulant Rx
• Superior to single or DAPT
to prevent stroke
• For life
• Lowest NOACs dose should
be considered (Dabigatran
110 mg bd; rivaroxaban 15
mg qd, apixaban 2.5 mg bd)
DAPT Rx
• Superior to ASA
alone in ACS
• Essential to prevent
stent thrombosis
post PCI
• ≥12 months
Dual or Triple Rx
• Medications?
• How long?
• Data?
Anti-thrombotic therapy for ACS/PCI plus AF

4. CHA2DS2-VASc
CHA2DS2-VASc criteria Score
Congestive heart failure/
left ventricular dysfunction
1
Hypertension 1
Age 75 years 2
Diabetes mellitus 1
Stroke/transient ischaemic attack/TE 2
Vascular disease (prior myocardial
infarction, peripheral artery disease, or
aortic plaque)
1
Age 65–74 years 1
Sex category (i.e. female gender) 1
Lip G et al. Chest 2010;137:263–72;
Lip G et al. Stroke 2010;41:2731–8;
HAS-BLED risk criteria Score
Hypertension
(SBP >160 mmHg)
1
Abnormal renal or liver function (1
point each)
1 or 2
Stroke 1
Bleeding
(history or predisposition)
1
Labile INRs 1
Elderly
(e.g. age >65 years)
1
Drugs† or alcohol
(1 point each)
1 or 2
Pisters R et al. Chest 2010;138:1093–100
HAS-BLED

5. For patients with AF, guidelines recommend initial triple therapy
followed by dual therapy after PCI with stent
5Kirchhof et al. Eur Heart J 2016
OAC + ASA + clopidogrel
Elective PCI with stent,
or ACS at high bleeding risk
ACS with low
bleeding risk
ACS or
elective PCI with stent
1 month or up to 6 months
+ +
(6–)12 months*
OAC only
Lifelong
OAC+ ASA + clopidogrel
+ +
OAC + ASA or clopidogrel
+

6. Methods-
 Open-label, multi-centre, randomised, controlled trial in
15 centers in Belgium and the Netherlands
 Clopidogrel alone (double therapy) or clopidogrel plus
aspirin (triple therapy)
 The primary outcome was any bleeding within 1
year of PCI
Lancet 2013; 381: 1107–15

7. WOEST Primary endpoint- Total number of bleeding events (TIMI)
Lancet 2013; 381: 1107–15
WOEST-Secondary and safety endpoints- lower mortality rate in double versus triple therapy

8. OBJECTIVES …Reducing of clopidogrel therapy from 6
months to 6 weeks gives superior net clinical outcome in
patients receiving concomitant aspirin and OAC.
METHODS… 614 patients receiving 6-week clopidogrel (n=
307) vs. 6-month therapy (n= 307).
The primary endpoint = death/MI/definite ST/stroke/or
TIMI major bleeding at 9 months
J Am Coll Cardiol 2015;65:1619–29
Primary endpoint
TIMI major bleeding

9. 1. Compare efficacy and safety outcomes of
triple therapy vs dual therapy
2. Hypothesize OAC plus clopidogrel could be
the optimal regimen for patients with
indications for OAC receiving stent
implantation.
16 eligible trials
including 9185 patients
Clin. Cardiol. 38, 8, 499–509 (2015)

10. Main findings from
meta-analysis
1. Triple therapy has a similar risk of MACE
compared with dual therapy (OR: 1.06, 95% CI:
0.82-1.39, P = 0.65)
2. The risk of all-cause mortality, MI, and ST did
not significantly differ between the triple and dual
therapy groups
 all-cause mortality, OR: 0.98, 95% CI: 0.76-
1.27,P = 0.89
 MI, OR: 1.01, 95% CI: 0.77-1.31, P = 0.97
 ST, OR: 0.91, 95% CI: 0.49-1.69, P = 0.75
Clin. Cardiol. 38, 8, 499–509 (2015)

11. 1. Triple therapy was associated with a
significantly lower incidence of ischemic
stroke (OR: 0.57, 95% CI: 0.35-0.94,P = 0.03)
2. Significantly increased major bleeding in the
triple therapy group (OR: 1.52, 95% CI: 1.11-
2.10, P = 0.01), as well as minor bleeding
(OR: 1.59, 95% CI: 1.05-2.42, P =0.03)
Less ischemic stroke and more bleeding with triple therapy
 OAC plus clopidogrel was associated with at
least similar efficacy and safety outcomes
compared with triple therapy.
 Triple therapy regimens could be
replaced by OAC plus clopidogrel without
any concern about additional risk of
thrombotic events.
Clin. Cardiol. 38, 8, 499–509 (2015)

12. PIONEER AF-PCI compared regimens of rivaroxaban with single or
dual antiplatelet therapy
12
Rivaroxaban 15 mg /10 mg OD + clopidogrel
End of treatment
(12 months)
Rivaroxaban 2.5 mg BID
+ DAPT*
VKA (INR 2.0–3.0)
+ DAPT*
Rivaroxaban 15 mg/10 mg OD
+ low-dose ASA
VKA +
low-dose ASA
1:1:1
Paroxysmal,
persistent or
permanent AF,
undergoing PCI
(with stent
placement)
N=2124
R
Group 1
Group 2
Group 3
Primary endpoint: clinically-significant bleeding
Multicentre, randomized, open-label trial
Gibson CM et al. N Engl J Med 2016;375:2423–34

13. PIONEER AF-PCI key inclusion and exclusion criteria
13
 Male or female patients with AF aged ≥18
years
 Paroxysmal, persistent, or permanent AF
 Undergone PCI (with stent placement)
Key inclusion criteria
 Active internal bleeding, clinically significant
bleeding, or bleeding at non-compressible
site
 Cardiogenic shock at randomization
 History of ICH
 Clinically significant GI bleeding in past
12 months
 History of stroke or TIA
 Severe renal impairment with CrCl <30
mL/min
 Suspected or documented stent thrombosis
during index procedure or PCI with stent
placement for previously stented lesion during
the index procedure or within past 12 months
Key exclusion criteria
Gibson CM et al. N Engl J Med 2016;375:2423–34
• Any symptomatic intracranial haemorrhage
OR
• Clinically overt signs of haemorrhage
(including imaging) associated with a drop
in haemoglobin of ≥5 g/dL (or when
haemoglobin concentration is not available,
an absolute drop in haematocrit of ≥15%)
TIMI major bleeding

14. PIONEER AF-PCI: primary safety endpoint results
14
Bleeding requiring
medical attention
Minor bleeding
Major bleeding
Favours Group 1 Favours Group 3
1.50.5 20 1
HR (95% CI)
Primary endpoint:
clinically significant
bleeding
1.50.5 20 1
HR (95% CI)
Favours Group 2 Favours Group 3
Group 1 vs Group 3 Group 2 vs Group 3
Composite of major/ minor bleeding (TIMI), or bleeding requiring medical attention
Gibson CM et al. N Engl J Med 2016;375:2423–34
Group 1: R15/10 + clopi.
Group 2: R2.5 + DAPT
Group 3: Triple therapy

15. PIONEER AF-PCI: lower rate of the primary endpoint
in both rivaroxaban groups vs the triple therapy group
15
Composite of bleeding events Group 3
26.7%
Group 2
18.0%
Group 1
16.8%
0 30 60 90 180 270 360
Days
0
5
10
15
20
25
30
Cumulativeincidenceofclinically
significantbleeding(%)
Group 1 vs 2: HR: 0.59; 95% CI: 0.47–0.76); P<0.001
Group 2 vs 3: HR: 0.63; 95% CI: 0.50–0.80; P<0.001
Group 1: R15/10 + clopi.
Group 2: R2.5 + DAPT
Group 3: Triple therapy
Gibson CM et al. N Engl J Med 2016;375:2423–34
Most patients in PIONEER AF-PCI received triple therapy
for 6 months (37%) or 12 months (53%)

16. PIONEER AF-PCI showed similar rates of thromboembolic events
16
MACE= composite of CV death, MI, and stroke
6.5
0.8
5.6
0.9
6.0
0.7
0
2
4
6
8
10
MACE Stent thrombosis
Patients(%)
Group 1
Group 2
Group 3
The study was not powered to show superiority or non-inferiority
between treatments in efficacy endpoints
n=694
n=704
n=695
HR: 1.08; 95% CI: 0.69–1.68; P=0.75
HR: 0.93; 95% CI: 0.59–1.48; P=0.76
HR: 1.20; 95% CI: 0.32–4.45; P=0.79
HR: 1.44; 95% CI: 0.40–5.09; P=0.57
Gibson CM et al. N Engl J Med 2016;375:2423–34

17. ESC GUIDELINES 2017
17

18. ESC GUIDELINES 2017
18

19. ESC GUIDELINES 2017
19

20. Adapted from Dewilde et al. J Am Coll Cardiol 2014; Cannon et al. Clin Cardiol 2016
Clopidogrel OAC
ASA
Dual therapy
▼stent thrombosis
▼major bleeding
≈coronary events
Dual
therapy
▲CV
events
▲mortality
Dual
therapy
▲MI
▲stent
thrombosis
Triple therapy
High bleeding event
rates, bleeding
complications,
MACE, and
mortality
RE-DUAL PCI
assessed safety of
this combination
20
What was the design of the
RE-DUAL PCI trial?
 Multicentre, prospective,
randomized, open, blinded end-
point design
 Study drug should be
administered 6 hours after
sheath removal and no later
than 120 hours post-PCI (≤72
hours is preferable)
 ASA discontinued after 1 month
after BMS and 3 months after DES

21. Dabigatran 150 mg BID + P2Y12 inhibitor
Dabigatran 110 mg BID + P2Y12 inhibitor
Warfarin (INR 2.0–3.0) + P2Y12 inhibitor + ASA†
RE-DUAL PCI tested the safety and efficacy of two regimens of dual
therapy with dabigatran without ASA vs triple therapy with warfarin
21
Primary
endpoint:
ISTH major
or CRNM
bleeding
Patients
with AF
undergoing
PCI with
stenting
Randomization
≤120 hours
post-PCI*
R
6-month minimum treatment duration,
maximum treatment duration 30 months
(mean follow-up ~14 months)
N=2725
Cannon CP et al. N Engl J Med 2017;doi: 10.1056/NEJMoa1708454

22. • The primary endpoint was time to first ISTH major
or clinically relevant non-major bleeding event
• Formally tested endpoints included:
– non-inferiority and superiority of 110 mg and 150
mg dual therapy in time to first ISTH major bleeding
event or CRNM bleeding event
– time to first event of death, thromboembolic event
(MI, stroke, systemic embolism) with and without
unplanned revascularization
• 100% of outcome events were independently
adjudicated by blinded external committee
Study objective and design
ISTH major bleeding event
• Symptomatic bleeding in a critical area or organ*,
and/or
• Bleeding associated with reduced haemoglobin
≥2 g/dL (1.24 mmol/L) or transfusion of ≥2 units
of blood or packed cells† and/or
• Fatal bleed
CRNM bleeding event
Not meeting criteria for a major bleed but
prompts ≥1 of:
• Hospital admission
• Physician-guided medical or surgical treatment
• Physician-guided change, interruption (≥1 dose)
or discontinuation of study drug

23. Patients were randomized based on age group and location,
according to local label
Worldwide <80 years ≥80 years
(except USA, Japan)
USA <80 years ≥80 years
Japan <70 years ≥70 years
Dabigatran 150 mg
dual therapy
Warfarin
triple therapy
Dabigatran 110 mg
dual therapy
N=981
For comparison of outcomes:
N=981N=764N=763 vs vs
Warfarin
triple therapy
(age-matched)
23
Cannon CP et al. N Engl J Med 2017;doi: 10.1056/NEJMoa1708454

24. RE-DUAL PCI: key inclusion and exclusion criteria
Cannon et al. Clin Cardiol 2016
 Patients aged ≥18 years with paroxysmal, persistent or permanent NVAF
 ACS successfully treated by PCI and stenting (BMS or DES)
 Stable CAD with ≥1 lesion eligible for PCI that was successfully treated
by elective PCI and stenting (BMS or DES)
Inclusion
 Cardiogenic shock during current hospitalization
 Use of fibrinolytics within 24 hours of randomization that, in the
investigator’s opinion, will put patient at high risk of bleeding
 Stroke or major bleeding event within 1 month prior to screening visit
 Severe renal impairment (CrCl <30mL/min)
Exclusion
24

25. RE-DUAL PCI: Baseline characteristics
Dabigatran 110 mg
dual therapy
(n=981)
Warfarin triple
therapy
(n=981)
Dabigatran 150 mg
dual therapy
(n=763)
Warfarin triple
therapy
(n=764)
Age, years, mean 71.5 71.7 68.6 68.8
≥80 (USA, ROW), ≥70 (Japan), % 22.9 22.9 1.0 1.0
<80 (USA, ROW), <70 (Japan), % 77.1 77.1 99.0 99.0
Male, % 74.2 76.5 77.6 77.7
Baseline CrCl, mL/min, mean 76.3 75.4 83.7 81.3
Diabetes mellitus, % 36.9 37.9 34.1 39.7
CHA2DS2−VASc score (mean) 3.7 3.8 3.3 3.6
Modified HAS-BLED score at
baseline (mean)
2.7 2.8 2.6 2.7
ACS indication for PCI, % 51.9 48.4 51.2 48.3
DES placed only, % 82.0 84.2 81.4 83.5
25
Cannon CP et al. N Engl J Med 2017;doi: 10.1056/NEJMoa1708454

26. Significantly lower rates of ISTH major bleeding or CRNMBE
with dabigatran dual therapy
26Cannon et al. ESC 2017; Cannon et al. N Engl J Med 2017
Probabilityofevent(%)
0
0 90 180 270 360 450 540 630 720
Time to first event (days)
40
35
30
25
20
15
10
5
Warfarin
triple therapy
Dabigatran 110 mg
dual therapy
HR: 0.52 (95% CI: 0.42–0.63)
Non-inferiority P<0.001
P<0.001
0 90 180 270 360 450 540 630 720
Time to first event (days)
40
35
30
25
20
15
10
5
0
Dabigatran 150 mg
dual therapy
Warfarin
triple therapy
HR: 0.72 (95% CI: 0.58–0.88)
Non-inferiority P<0.001
P=0.002

27. Significantly lower rates of ISTH major bleeding or CRNMBE
with dabigatran dual therapy
0
5
10
15
20
25
30
35
Dabigatran 110 mg
dual therapy
(n=981)
Warfarin
triple therapy
(n=981)
151
(15.4%)
264
(26.9%)
HR: 0.52 (95% CI: 0.42–0.63)
P<0.001
Patientswithoutcomeevent(%)
ARR: 11.5%
Dabigatran 150 mg
dual therapy
(n=763)
Warfarin
triple therapy
(n=764)
154
(20.2%)
196
(25.7%)
HR: 0.72 (95% CI: 0.58–0.88)
P=0.002
ARR: 5.5%
27Cannon et al. ESC 2017; Cannon et al. N Engl J Med 2017

28. ISTH and TIMI major bleeding: significantly lower rates for
dabigatran dual therapy
0
1
2
3
4
5
6
7
8
9
10
5.0%
9.2%
5.6%
8.4%
1.4%
3.8%
2.1%
3.9%
HR: 0.52 (95% CI: 0.37–0.74)
P<0.001
HR: 0.64 (95% CI: 0.43–0.94)
P=0.02
HR: 0.37
(95% CI: 0.20–0.68)
P=0.002
HR: 0.51
(95% CI: 0.28–0.93)
P=0.03
TIMI major bleeding event
D110-DT
n=981
D110-DT
n=981
W-TT
n=981
D150-DT
n=763
W-TT
n=764
W-TT
n=981
W-TT
n=764
D150-DT
n=763
ISTH major bleeding event
ISTH major bleeding definition: fatal, critical organ (including ICH), clinically overt bleeding with fall in Hb ≥2 g/dL;
TIMI major bleeding definition: fatal, ICH, clinically overt bleeding with fall in Hb ≥5 g/dL.
28
Patientswithoutcomeevent(%)
Cannon et al. N Engl J Med 2017

29. TIMI major or minor bleeding: significantly lower rate for
dabigatran dual therapy
TIMI major bleeding definition: fatal, ICH, clinically overt bleeding with fall in Hb ≥5 g/dL
TIMI minor bleeding definition: Clinically overt bleeding (including imaging), resulting in Hb drop of 3-5 g/dL
0
1
2
3
4
5
6
7
8
9
10
Dabigatran 110 mg
dual therapy
(n=981)
Warfarin
triple therapy
(n=981)
HR: 0.41 (95% CI: 0.26–0.63)
P<0.001
Dabigatran 150 mg
dual therapy
(n=763)
Warfarin
triple therapy
(n=764)
HR: 0.53 (95% CI: 0.33–0.85)
P=0.009
3.0%
7.0%
3.5%
6.3%
Patientswithoutcomeevent(%)
29Cannon et al. N Engl J Med 2017

30. Cannon et al. N Engl J Med 2017
Intracranial haemorrhage: fewer events with
dabigatran dual therapy
0
1
2
3
4
5
6
7
8
9
10
Dabigatran 110 mg
dual therapy
(n=981)
Warfarin
triple therapy
(n=981)
HR: 0.30 (95% CI: 0.08–1.07)
P=0.06
Dabigatran 150 mg
dual therapy
(n=763)
Warfarin
triple therapy
(n=764)
HR: 0.12 (95% CI: 0.02–0.98)
P=0.047
0.3%
1.0%
0.1%
1.0%
Patientswithoutcomeevent(%)
30

31. Dabigatran dual therapy was non-inferior to warfarin triple therapy
in the composite efficacy endpoint
Cannon et al. N Engl J Med 2017; Cannon et al ESC 2017
0
2
4
6
8
10
12
14
16
18
20
Dabigatran (combined
dose) dual therapy
(n=1744)
Warfarin
triple therapy
(n=981)
13.7% 13.4%
HR: 1.04 (95% CI: 0.84–1.29)
Non-inferiority P=0.005
35
30
25
20
15
10
5
0
Probabilityofevent(%)
0 90 180 270 360 450 540 630 720
Time to first event (days)
Dabigatran (combined doses)
dual therapy
Warfarin
triple therapy
Patientswithoutcomeevent(%)
Composite endpoint of death or thromboembolic event
(MI, stroke or systemic embolism) or unplanned revascularization (PCI/CABG)
31

32. 0
2
4
6
8
10
12
14
Dabigatran (combined
dose) dual therapy
(n=1744)
Warfarin
triple therapy
(n=981)
9.6%
8.5%
HR: 1.17 (95% CI: 0.90–1.53)
Non-inferiority P=0.11
Patientswithoutcomeevent(%)
Secondary endpoint: time to death or thromboembolic event
(death, MI, stroke or SE)
Cannon et al. N Engl J Med 2017 32

33. No significant differences in efficacy outcomes
Cannon et al. N Engl J Med 2017: Cannon et al. ESC 2017
Dabigatran 110
mg dual therapy
(n=981)
n (%)
Warfarin triple
therapy (n=981)
n (%)
D110 DT vs warfarin TT
Dabigatran 150
mg dual therapy
(n=763)
n (%)
Warfarin triple
therapy
(n=764)
n (%)
D150 DT vs warfarin TT
HR (95% CI) P value HR (95% CI) P value
All-cause death 55 (5.6) 48 (4.9) 1.12 (0.76–1.65) 0.56 30 (3.9) 35 (4.6) 0.83 (0.51–1.34) 0.44
Stroke 17 (1.7) 13 (1.3) 1.30 (0.63–2.67) 0.48 9 (1.2) 8 (1.0) 1.09 (0.42–2.83) 0.85
Unplanned
revascularization
76 (7.7) 69 (7.0) 1.09 (0.79–1.51) 0.61 51 (6.7) 52 (6.8) 0.96 (0.65–1.41) 0.83
MI 44 (4.5) 29 (3.0) 1.51 (0.94–2.41) 0.09 26 (3.4) 22 (2.9) 1.16 (0.66–2.04) 0.61
Stent thrombosis 15 (1.5) 8 (0.8) 1.86 (0.79–4.40) 0.15 7 (0.9) 7 (0.9) 0.99 (0.35–2.81) 0.98
RE-DUAL PCI was not powered to show differences in individual thromboembolic endpoints
33

34. 0.1 1 10 0.1 1 10
Bleeding events: ACS vs non-ACS
D110-DT
n/N (%)
Warfarin-TT
n/N (%)
ISTH Major/CRNM Bleeding
ACS 75/509 (14.7) 132/475 (27.8)
Non-ACS76/472 (16.1) 132/505 (26.1)
ISTH Major Bleeding
ACS 26/509 (5.1) 55/475 (11.6)
Non-ACS 23/472 (4.9) 35/505 (6.9)
TIMI Major Bleeding
ACS 7/509 (1.4) 23/475 (4.8)
Non-ACS 7/472 (1.5) 14/505 (2.8)
D150-DT
n/N (%)
Warfarin-TT
n/N (%)
ISTH Major/CRNM Bleeding
ACS 80/391 (20.5) 100/369 (27.1)
Non-ACS 74/372 (19.9) 96/394 (24.4)
ISTH Major Bleeding
ACS 25/391 (6.4) 40/369 (10.8)
Non-ACS 18/372 (4.8) 24/394 (6.1)
TIMI Major Bleeding
ACS 9/391 (2.3) 19/369 (5.1)
Non-ACS 7/372 (1.9) 11/394 (2.8)
P interaction P interaction
0.34
0.14
0.30
0.57
0.39
0.47
Favors Warfarin-TTFavors D110-DT Favors Warfarin-TTFavors D150-DT
Oldgren J, presented at AHA 2017

35. 0.1 1 100.1 1 10
Death and thromboembolic events: ACS vs non-ACS
D110-DT
n/N (%)
Warfarin-TT
n/N (%)
DTE or Unplanned Revascularization
ACS 92/509 (18.1) 70/475 (14.7)
Non-ACS 57/472 (12.1) 61/505 (12.1)
Myocardial Infarction
ACS 32/509 (6.3) 16/475 (3.4)
Non-ACS 12/472 (2.5) 13/505 (2.6)
All-cause Death
ACS 34/509 (6.7) 24/475 (5.1)
Non-ACS 21/472 (4.4) 24/505 (4.8)
D150-DT
n/N (%)
Warfarin-TT
n/N (%)
DTE or Unplanned Revascularization
ACS 41/391 (10.5) 52/369 (14.1)
Non-ACS 49/372 (13.2) 46/394 (11.7)
Myocardial Infarction
ACS 13/391 (3.3) 11/369 (3.0)
Non-ACS 13/372 (3.5) 11/394 (2.8)
All-cause Death
ACS 12/391 (3.1) 19/369 (5.1)
Non-ACS 18/372 (4.8) 16/394 (4.1)
P interaction P interaction
0.38
0.20
0.11
0.82
0.46 0.15
Favors Warfarin-TTFavors D110-DT Favors Warfarin-TTFavors D150-DT
Oldgren J, presented at AHA 2017

36. 0.1 1 100.1 1 10
Bleeding events: BMS vs DES
D110-DT
n/N (%)
Warfarin-TT
n/N (%)
ISTH Major/CRNM Bleeding
BMS 19/148 (12.8) 35/133 (26.3)
DES 127/804 (15.8) 288/826 (27.6)
ISTH Major Bleeding
BMS 4/148 (2.7) 13/133 (9.8)
DES 44/804 (5.5) 77/826 (9.3)
TIMI Major Bleeding
BMS 0/148 (0.0) 8/133 (6.0)
DES 13/804 (1.6) 29/826 (3.5)
0.52
0.18
0.98
D150-DT
n/N (%)
Warfarin-TT
n/N (%)
ISTH Major/CRNM Bleeding
BMS 18/123 (14.6) 27/107 (25.2)
DES 133/621 (21.4) 168/638 (26.3)
ISTH Major Bleeding
BMS 8/123 (6.5) 10/107 (9.3)
DES 34/621 (5.5) 54/638 (8.5)
TIMI Major Bleeding
BMS 4/123 (3.3) 7/107 (6.5)
DES 12/621 (1.9) 23/638 (3.6)
0.31
0.88
0.91
P interaction P interaction
Favors Warfarin-TTFavors D110-DT Favors Warfarin-TTFavors D150-DT
Oldgren J, presented at AHA 2017

37. 0.1 1 100.1 1 10
Death and thromboembolic events: BMS vs DES
D110 dual-DT
n/N (%)
Warfarin-TT
n/N (%)
DTE or Unplanned Revascularization
BMS 25/148 (16.9) 17/133 (12.8)
DES 118/804 (14.7) 108/826 (13.1)
Myocardial Infarction
BMS 9/148 (6.1) 4/133 (3.0)
DES 35/804 (4.4) 24/826 (2.9)
All-cause Death
BMS 7/148 (4.7) 5/133 (3.8)
DES 43/804 (5.3) 41/826 (5.0)
0.72
0.66
D150-DT
n/N (%)
Warfarin-TT
n/N (%)
DTE or Unplanned Revascularization
BMS 16/123 (13.0) 12/107 (11.2)
DES 73/621 (11.8) 81/638 (12.7)
Myocardial Infarction
BMS 3/123 (2.4) 2/107 (1.9)
DES 23/621 (3.7) 19/638 (3.0)
All-cause Death
BMS 8/123 (6.5) 4/107 (3.7)
DES 22/621 (3.5) 30/638 (4.7)
0.55
0.96
P interaction P interaction
0.20
0.85
Favors Warfarin-TTFavors D110-DT Favors Warfarin-TTFavors D150-DT
Oldgren J, presented at AHA 2017

38. D150-DT
n/N (%)
Warfarin-TT
n/N (%)
ISTH Major/CRNM Bleeding
Ticagrelor* 24/104 (23.1) 25/73 (34.2)
Clopidogrel† 130/659 (19.7)171/691 (24.7)
ISTH Major Bleeding
Ticagrelor* 8/104 (7.7) 12/73 (16.4)
Clopidogrel† 35/659 (5.3) 52/691 (7.5)
TIMI Major Bleeding
Ticagrelor* 2/104 (1.9) 7/73 (9.6)
Clopidogrel† 14/659 (2.1) 23/691 (3.3)
0.1 1 10 0.1 1 10
Bleeding events: ticagrelor/clopidogrel
P (interaction)
0.69
0.75
0.39
D110-DT
n/N (%)
Warfarin-TT
n/N (%)
ISTH Major/CRNM Bleeding
Ticagrelor* 28/132 (21.2) 34/91 (37.4)
Clopidogrel† 123/849 (14.5) 230/890 (25.8)
ISTH Major Bleeding
Ticagrelor* 11/132 (8.3) 15/91 (16.5)
Clopidogrel† 38/849 (4.5) 75/890 (8.4)
TIMI Major Bleeding
Ticagrelor* 3/132 (2.3) 9/91 (9.9)
Clopidogrel† 11/849 (1.3) 28/890 (3.1)
Favors Warfarin-TTFavors D150-DT
P (interaction)
0.53
0.37
0.17
Favors Warfarin-TTFavors D110-DT
Oldgren J, presented at AHA 2017

39. 0.1 1 100.1 1 10
Death and thromboembolic events: ticagrelor/clopidogrel
P (interaction)
0.24
0.71
0.64
D110-DT
n/N (%)
Warfarin-TT
n/N (%)
DTE or Unplanned Revascularization
Ticagrelor* 25/132 (18.9) 20/91 (22.0)
Clopidogrel† 124/849 (14.6) 111/890 (12.5)
Myocardial Infarction
Ticagrelor* 11/132 (8.3) 6/91 (6.6)
Clopidogrel† 33/849 (3.9) 23/890 (2.6)
All-cause Death
Ticagrelor* 7/132 (5.3) 5/91 (5.5)
Clopidogrel† 48/849 (5.7) 43/890 (4.8)
P (interaction)
0.45
0.35
0.46
D150-DT
n/N (%)
Warfarin-TT
n/N (%)
DTE or Unplanned Revascularization
Ticagrelor* 16/104 (15.4) 15/73 (20.5)
Clopidogrel† 74/659 (11.2) 83/691 (12)
Myocardial Infarction
Ticagrelor* 5/104 (4.8) 5/73 (6.8)
Clopidogrel† 21/659 (3.2) 17/691 (2.5)
All-cause Death
Ticagrelor* 3/104 (2.9) 4/73 (5.5)
Clopidogrel† 27/659 (4.1) 31/691 (4.5)
Favors Warfarin-TTFavors D110-DT Favors Warfarin-TTFavors D150-DT
Oldgren J, presented at AHA 2017

40. Summary
40
1. AF plus ACS/PCI: challenge clinical scenario that need careful assessment for risk of embolic
event (CHA2DS2-VASc) and bleeding (HAS-BLED) to have appropriate anti-thrombotic therapy.
2. Dual therapy seems to be safe (reduce risk of bleeding) and efficacy (non-inferiority for
thromboembolic events) for patients with atrial fibrillation undergoing PCI with stent implantation.
3. RE-DUAL PCI: Dabigatran dual therapy regimens (110 mg and even 150 mg bid doses)
significantly reduce the risk of major bleeding; provide an alternative for managing post-PCI
patients with atrial fibrillation.
4. The benefit of the dabigatran dual therapy was consistent in subgroup analysis (ACS or non-ACS/
DES or BMS / P2Y12 inhibitors ticagrelor or clopidogrel).

41. Thank you for your attention!
41