Management of AF patients with ACS undergoing PCI.pptx

Management of AF patients
with ACS/undergoing PCI
Dr. Praveen Nagula
MD,DM
Associate Professor of Cardiology
Osmania Medical College/General Hospital, Hyderabad

INTRODUCTION
 Atrial fibrillation is the most common arrhythmia in patients undergoing PCI.
 Presence of AF in ACS – increases in-hospital and 30 day mortality.
 Managing the thrombotic risk and bleeding is an herculean task.
 Individualizing the duration, number of antithrombotics and anticoagulants is of
prime importance.
 NOACs and single antiplatelet with trial evidence suggest effective outcomes with
less bleeding in this subset of patients.

Case
• A 54 year male, hypertensive, diabetes, had CVA 2 years ago. He had raised creatinine
(2.2mg/dl) and haemoglobin of 9.6gm/dl. Now admitted with chest pain. ECG showed
extensive anterior wall STEMI. Echo showed dilated LA,LV and severe LV dysfunction.
He underwent PPCI Stent to LAD. During his hospital stay, he had AF with FVR reverted
pharmacologically. At discharge, what drugs to be kept for prevention of thrombotic
events in future as well as protect from bleeding complications?
• A. Aspirin 150mg, Clopidogrel 75 mg, Rivaroxaban 20 mg OD for 3 months.
• B. Aspirin 75mg, Clopidogrel75mg, Rivaroxaban 15 mg BID for 1 month
• C. Aspirin 75mg, Clopidogrel 75mg, Apixaban 2.5 mg BD for 3 months
• D. Aspirin 75mg, Clopidogrel 75mg, Apixaban 5mg BD for one month
• E. None of the above.

AF and ACS – A DOUBLE EDGED SWORD
• Patients with NVAF with a recent ACS and/or have undergone PCI:
 Require anticoagulation for stroke risk reduction associated with NVAF.
 Require add-on single or dual antiplatelet therapy for reducing the risk of
ischemic events in ACS or PCI.
 Combining these regimens increases the risk for bleeding.
 The optimal combination of anticoagulation and antiplatelet therapy which
balances bleeding risk and thrombotic risk is unknown.
ACS, acute coronary syndrome; NVAF, non-valvular atrial fibrillation;
PCI, percutaneous coronary intervention.
Lopes RD, et al. N Engl J Med 2019;380:1509–24

• AGE 54 years
• HYPERTENSION
• DIABETES
• DERANGED RFT
• CVA
• ACS
• AF

Coronary stenting in patient with AF and high risk of stroke
Stent thrombosis Stroke
Major bleeding
DAPT OAC
+
You cannot simultaneously prevent all three
Gibson et al. N Engl J Med 2016;375:2423-34.

How best these patients can be managed?
What is the trial evidence?

Patients With Atrial Fibrillation Undergoing Coronary Stent
Placement: PIONEER AF-PCI1
 Primary endpoint: TIMI major + minor and bleeding requiring medical attention
 Secondary endpoint: CV death, MI, stroke and stent thrombosis
*Rivaroxaban dosed at 10 mg once daily in patients with CrCl of 30 to <50 mL/min.
†Alternative P2Y12 inhibitors: 10 mg once-daily prasugrel or 90 mg twice-daily ticagrelor.
‡Low-dose aspirin (75-100 mg/d).
PCI- Percutaneous coronary Intervention; TIMI: Thrombolysis in Myocardial Infarction; CV: Cardiovascular; MI: Myocardial Infarction
# Participants who received treatment for 1 to 6 months received this treatment for the remainder of 12-month treatment period
 2100 patients with
NVAF
 PCI with stent
placement
 No prior
stroke/TIA, GI
bleeding 12
months before
randomization,
Hb<10g/dL,
CrCl<30mL/min
R
A
N
D
O
M
I
Z
E
1,6, or 12 months
Rivaroxaban 15 mg qd*
Clopidogrel 75 mg qd†
Rivaroxaban 15mg qd#
Aspirin 75-100 mg qd
Rivaroxaban 2.5 mg bid
Aspirin 75-100 mg qd‡
VKA (target INR 2.0-3.0)#
VKA (target INR 2.0-3.0)
≤72
hours
After
Sheath
removal
1,6, or 12 months
End of
treatment
12 months
WOEST Like
ATLAS Like
Triple
Therapy
Pre randomization MD Choice
Pre randomization MD Choice
1. Gibson CM, et al. N Engl J Med 2016;375:2423-34..

PIONEER AF-PCI: Summary of results
Primary endpoint was a composite of
major bleeding or minor bleeding according to
TIMI criteria or bleeding requiring medical attention.
MACE was a composite of death from cardiovascular
causes, myocardial infarction or stroke.
Rivaroxaban 15 mg
+ P2Y12 inhibitor
vs. warfarin + DAPT
Rivaroxaban 2.5 mg
+ DAPT
vs. warfarin + DAPT
Primary endpoint:
clinically significant bleeding
Major bleeding
Minor bleeding
Bleeding requiring medical attention
Secondary endpoint: MACE
Stent thrombosis
Favours
rivaroxaban 15 mg
+ P2Y12 inhibitor
0 0.5 1 1.5 2
HR (95% CI)
0 0.5 1 1.5 2
HR (95% CI)
Favours
warfarin
+ DAPT
Favours
rivaroxaban 2.5 mg
+ DAPT
Favours
warfarin
+ DAPT
.
Gibson CM, et al. N Engl J Med 2016;375:2423-34.

Interpretation of the PIONEER Results
 Initial important evidence in a field where it has been lacking
 Clear signal of less bleeding with both reduced antithrombotic regimens
 No aspirin (riva 15 + P2Y12)
 Very low-dose OAC (riva 2.5 + P2Y12 + aspirin)
 Effects on ischemic events were imprecise with wide confidence intervals
 Stroke: No Aspirin = HR 1.07, 95% CI 0.39-2.96
Low-dose OAC = HR 1.36, 95% CI 0.52-3.58
 Stent thrombosis: No aspirin = HR 1.20, 95% CI 0.32-4.45
Low-dose OAC = HR 1.44, 95% CI 0.40-5.09
Gibson CM, et al. N Engl J Med 2016;375:2423-34.

Dabigatran etexilate 150 mg BID + P2Y12 inhibitor
1o End Point
Time to first ISTH major bleeding or clinically relevant non-major bleeding event
n~2,500 patients (approx. 834 patients per arm)
Dabigatran etexilate 110 mg BID + P2Y12 inhibitor
Warfarin (INR 2.0 – 3.0) + P2Y12 inhibitor + ASA
Paroxysmal, persistent or
permanent NVAF,
PCI with stenting [BMS or
DES] elective or ACS
Screening
R
0-120 hours
post-PCI
Trial design
Patients >80 years living outside of the
USA will be assigned to 110mg dabigatran
etexilate (BID) or warfarin in a 1:1 ratio
RE-DUAL PCI
ACS: Acute Coronary Syndrome; ASA: Acetylsalicylic acid; BMS: Bare Metal Stent
DES: Drug Eluting Stent; ISTH: International Society on Thrombosis and
Haemostasis; INR: International Normalized Ratio; NVAF: Non Valvular Atrial
Fibrillation; PCI: Percutaneous Coronary Intervention
ClinicalTrials.gov: NCT02164864
Cannon, C, et al. N Engl J Med 2017;377:1513-24.

RE-DUAL PCI: Summary of results
Cannon CP, et al. N Engl J Med 2017;377:1513–24.
Time to first ISTH or CRNM
bleeding event
Time to first ISTH
major bleeding event
Time to first TIMI
major bleeding event
Time to first TIMI
minor or major bleeding event
Thromboembolic events, death
or unplanned revascularization
Thromboembolic event or death
0 0.5 1 1.5 2
HR (95% CI)
Favours dabigatran + P2Y12 inhibitor Favours VKA + DAPT
Dabigatran 110 mg
Dabigatran 150 mg

Lessons from PIONEER and RE-DUAL
 Only patients undergoing PCI included
 NOAC + P2Y12 inhibitor appears to be associated with reduced bleeding versus triple
therapy with VKA
 PIONEER assessed doses of rivaroxaban not tested for stroke prevention
 Due to the design of RE-DUAL, it is unclear whether the reductions in bleeding are due to use of
dabigatran or the avoidance of aspirin
 Neither trial powered for efficacy outcomes
 In PIONEER, both doses of rivaroxaban were associated with numerical increases in CV death,
stroke and stent thrombosis
 In RE-DUAL, the lower dose of dabigatran (110 mg BID) was associated with a numerical
increase in death, MI, stroke and stent thrombosis
Gibson CM, et al. N Engl J Med 2016;375:2423-34
Valgimigli et al. European Heart Journal (2018) 39, 213–254
 Cannon, C, et al. N Engl J Med 2017;377:1513-24.
.

AUGUSTUS - Research Hypothesis
Two Independent Hypotheses:
 Apixaban is at least non-inferior or superior to VKA on the composite outcome
of ISTH major bleeding or clinically relevant non-major (CRNM) bleeding in
patients with NVAF who develop ACS and/or require PCI with concomitant
antiplatelet therapy (P2Y12 inhibitor) with or without aspirin.
 Single antiplatelet therapy with a P2Y12 inhibitor is superior to dual antiplatelet
therapy with a P2Y12 inhibitor and aspirin on the combined outcome of ISTH
major bleeding or CRNM bleeding in patients with NVAF with a recent ACS
and/or require PCI with planned concomitant anticoagulant therapy.
ACS, acute coronary syndrome; ISTH, International Society on Thrombosis and Haemostasis; NVAF, non-valvular atrial fibrillation; PCI, percutaneous coronary intervention; VKA, vitamin K antagonist.
1. Lopes RD, et al. N Engl J Med 2019;380:1509–24; 2. Apixaban LPDELI052021 (Version no. 13), dated 17th June 2021
Coadministration of apixaban with antiplatelet agents increases the risk of bleeding.2 Please consult local marketing label for full information.

AUGUSTUS: Trial design
Lopes RD, et al. Am Heart J 2018;200:17–23.
Aspirin Placebo
Double
blind
Aspirin Placebo
Double
blind
Apixaban 5 mg BID
Apixaban 2.5 mg BID in selected patients†
Primary outcome: ISTH major/CRNM bleeding Secondary outcome(s): death/hospitalization, death/ischaemic events
Randomise
N=4,600 patients
Aspirin for all on the day of ACS or PCI
Aspirin vs placebo after randomisation
Open label
VKA
(INR 2–3)
EXCLUSION
• Contraindication to DAPT
• Other conditions that require OAC (such as prosthetic valves or moderate or severe
mitral stenosis), severe renal insufficiency, and history of intracranial haemorrhage
• Recent or planned CABG, coagulopathy or ongoing bleeding, contraindication to
VKA, apixaban, all P2Y12 inhibitors, or aspirin
INCLUSION
• AF (prior, persistent, >6 hours); physician
decision for OAC
• ACS or PCI; planned P2Y12 inhibitor for ≥6
months
A P2Y12 inhibitor
for all patients x 6 months
“There is limited experience of coadministration with other platelet aggregation inhibitors (such as
GPIIb/IIIa receptor antagonists, dipyridamole, dextran or sulfinpyrazone) or thrombolytic agents.
As such agents increase the bleeding risk, coadministration of these products with apixaban is not
recommended
Dosing regimen of 2.5 mg BID in patients with 2 or more of the following criteria:
–Serum Cr ≥1.5 mg/dL
–Age ≥80 years
–Body weight ≤60 kg
P2Y12 inhibitor for all
patients X 6 months
Apixaban LPDELI052021 (Version no. 13), dated 17th June 2021

AUGUSTUS: Baseline characteristics
Total
(N=4,614)
Age, median (25th, 75th), years 70.7 (64.2, 77.2)
Female, % 29.0
CHA2DS2-VASc score, mean (SD) 3.9 (1.6)
HAS-BLED score, mean (SD) 2.9 (0.9)
Prior OAC, % 49.0
P2Y12 inhibitor, %
Clopidogrel 92.6
Prasugrel 1.1
Ticagrelor 6.2
Number of days from ACS/PCI to randomisation, mean (SD) 6.6 (4.2)
Qualifying index event, %
ACS and PCI 37.3
ACS and no PCI 23.9
Elective PCI 38.8
Lopes RD, et al. N Engl J Med 2019;380:1509–24.
CHA2DS2-VASc score, mean (SD) 3.9 (1.6)
HAS-BLED score, mean (SD) 2.9 (0.9)
Prior OAC, % 49.0
P2Y12 inhibitor, %
Clopidogrel 92.6
CHA2DS2-VASc score, congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, stroke, vascular disease, age 65–74 years, female
sex; HAS-BLED, hypertension, abnormal renal and liver function, stroke, bleeding, labile INR, elderly, drugs or alcohol; SD, standard deviation.

Major/CRNM bleeding
Number at risk:
Apixaban
VKA
Cumulative
incidence
of
event
(%)
0
0
2,290
2,259
Days since start of intervention
5
10
15
20
30
2,110
1,984
60
2,019
1,861
90
1,957
1,795
120
1,902
1,736
150
1,858
1,686
180
1,037
1,079
HR=0.69 (95% CI: 0.58, 0.81);
p<0.001 for non-inferiority,
p<0.001 for superiority;
ARR=4.2%; NNT=24 VKA: 14.7%
Apixaban: 10.5%
Apixaban vs VKA
recommended

Major/CRNM bleeding
ARI, absolute risk increase; NNH, number needed to harm.
Number at risk:
Aspirin
Placebo
Cumulative
incidence
of
event
(%)
0
0
5
10
15
20
30 60 90 120 150 180
HR=1.89 (95% CI: 1.59, 2.24);
p<0.001;
ARI=7.1%;
NNH=14
Aspirin: 16.1%
Placebo: 9.0%
Aspirin vs placebo
2,277
2,279
2,003
2,095
1,863
2,006
1,789
1,941
1,717
1,880
1,674
1,824
962
1,079
recommended

Major/CRNM bleeding1
1. Lopes RD, et al. N Engl J Med 2019;380:1509–24;
2. Lopes RD, et al. N Engl J Med 2019;380:1509–24. Suppl appendix.
Number at risk:
Apixaban and aspirin
Apixaban and placebo
VKA and aspirin
VKA and placebo
Cumulative
incidence
of
event
(%)
0
0
1,145
1,143
1,123
1,126
5
10
15
20
30
1,036
1,075
962
1,007
60
975
1,044
881
947
90
937
1,007
838
917
120
903
975
800
883
150
880
947
776
851
180
485
536
467
528
Apixaban + aspirin: 13.8%2
VKA + aspirin: 18.7%2
VKA + placebo: 10.9%2
Apixaban + placebo: 7.3%2
Apixaban + placebo
vs VKA + aspirin:2
11.4% absolute risk
reduction (NNT =9)
AUGUSTUS was not powered to compare individual primary outcomes for apixaban + placebo vs VKA + aspirin
NNT: Number needed to treat
recommended

Secondary Outcomes: Death or Ischemic event
Apixaban vs VKA and Aspirin vs Placebo
Endpoint Apixaban
(N=2306)
VKA
(N=2308)
Hazard Ratio
(95%CI)
Aspirin
(N=2307)
Placebo
(N=2307)
Hazard Ratio
(95%CI)
Death / Ischemic Events
(%)
6.7 7.1 0.93 (0.75-1.16) 6.5 7.3 0.89 (0.71-1.11)
Death (%) 3.3 3.2 1.03 (0.75-1.42) 3.1 3.4 0.91 (0.66-1.26)
CV Death (%) 2.5 2.3 1.05 (0.72-1.52) 2.3 2.5 0.92 (0.63-1.33)
Stroke (%) 0.6 1.1 0.50 (0.26-0.97) 0.9 0.8 1.06 (0.56-1.98)
Myocardial Infarction (%) 3.1 3.5 0.89 (0.65-1.23) 2.9 3.6 0.81 (0.59-1.12)
Definite or Probable Stent
Thrombosis (%)
0.6 0.8 0.77 (0.38-1.56) 0.5 0.9 0.52 (0.25-1.08)
Urgent Revascularization
(%)
1.7 1.9 0.90 (0.59-1.38) 1.6 2.0 0.79 (0.51-1.21)
Hospitalization (%) 22.5 26.3 0.83 (0.74-0.93) 25.4 23.4 1.10 (0.98-1.24)
All patients were concomitantly receiving P2Y12 therapy
Lopes RD, et al. N Engl J Med 2019;380:1509–24

Death/hospitalization
Number at risk:
Apixaban
VKA
Cumulative
incidence
of
event
(%)
0
0
Days since randomisation
10
20
30
40
30 60 90 120 150 180
HR=0.83 (95% CI: 0.74, 0.93);
p=0.002;
ARR=3.9%; NNT=26
VKA: 27.4%
Apixaban: 23.5%
Apixaban vs VKA
2,306
2,308
2,090
2,035
1,965
1,885
1,881
1,805
1,821
1,732
1,772
1,673
947
1,001
Recommended”

Death/hospitalization
NS, not significant.
Number at risk:
Aspirin
Placebo
Cumulative
incidence
of
event
(%)
0
0
10
20
30
40
30 60 90 120 150 180
HR=1.08 (95% CI: 0.96, 1.21);
p=NS
Placebo: 24.7%
Aspirin: 26.2%
Aspirin vs placebo
2,307
2,307
2,042
2,083
1,909
1,941
1,822
1,864
1,752
1,801
1,699
1,746
951
997
recommended

Death/hospitalisation1
AUGUSTUS was not powered to compare individual primary outcomes for apixaban + placebo vs VKA + aspirin
1. Lopes RD, et al. N Engl J Med 2019;380:1509–24;
2. Lopes RD, et al. N Engl J Med 2019; suppl appendix.
Number at risk:
Apixaban and aspirin
Apixaban and placebo
VKA and aspirin
VKA and placebo
Cumulative
incidence
of
event
(%)
0
0
10
20
30
40
30 60 90 120 150 180
Apixaban + aspirin: 24.9%2
VKA + aspirin: 27.5%2
VKA + placebo: 27.3%2
Apixaban + placebo: 22.0%2
Apixaban + placebo
vs VKA + aspirin:2
5.5% absolute risk
reduction (NNT=18)
1,153
1,153
1,154
1,154
1,026
1,064
1,016
1,019
970
995
939
946
923
958
899
906
888
933
864
868
863
909
836
837
459
488
492
509
recommended

Secondary End Point: Death &
Hospitalization

31
Amit N. Vora et al. Circulation. 2019;140:1960–1963

32
All-cause
hospitalization
HR 0.83 (95% CI 0.74–0.93);
p=0.002
Cardiovascular
hospitalization
HR 0.81 (95% CI 0.71–0.94);
p=0.004
Bleeding-related
hospitalization
HR 0.65 (95% CI 0.50–0.86);
p=0.003
Apixaban
VKA
Apixaban
VKA
Apixaban
VKA
Amit N. Vora et al. Circulation. 2019;140:1960–1963 Apixaban LPDELI052021 (Version no. 13), dated 17th June 2021
“There is limited experience of coadministration
with other platelet aggregation inhibitors (such as
GPIIb/IIIa receptor antagonists, dipyridamole,
dextran or sulfinpyrazone) or thrombolytic agents.
As such agents increase the bleeding risk,
coadministration of these products with apixaban
is not recommended

33
All-cause
hospitalization
HR 1.10 (95% CI 0.98–1.24);
p=0.104
Cardiovascular
hospitalization
HR 0.99 (95% CI 0.86–1.14);
p=0.862
Bleeding-related
hospitalization
HR 2.11 (95% CI 1.58–2.81);
p<0.001
Aspirin
Placebo
Aspirin
Placebo
Aspirin
Placebo
Amit N. Vora et al. Circulation. 2019;140:1960–1963
“There is limited experience of
coadministration with other platelet
aggregation inhibitors (such as
GPIIb/IIIa receptor antagonists, dipyridamole,
dextran or sulfinpyrazone) or thrombolytic
agents.
As such agents increase the bleeding risk,
coadministration of these products with
apixaban is not
recommended

All-cause
hospitalization
p=0.0031
Cardiovascular
hospitalization
p=0.0180
Bleeding-related
hospitalization
p<0.0001
Amit N. Vora et al. Circulation 2019 Amit N. Vora et al. Circulation. 2019;140:1960–1963

Ischemic outcomes
Endpoint
Apixaban
(N=2,306)
VKA
(N=2,308)
HR
(95% CI)
Death/ischaemic events (%) 6.7 7.1 0.93 (0.75, 1.16)
Death (%) 3.3 3.2 1.03 (0.75, 1.42)
CV death (%) 2.5 2.3 1.05 (0.72, 1.52)
Stroke (%) 0.6 1.1 0.50 (0.26, 0.97)
Myocardial infarction (%) 3.1 3.5 0.89 (0.65, 1.23)
Definite or probable stent thrombosis (%) 0.6 0.8 0.77 (0.38, 1.56)
Urgent revascularisation (%) 1.7 1.9 0.90 (0.59, 1.38)
Hospitalisation (%) 22.5 26.3 0.83 (0.74, 0.93)
Apixaban vs VKA

Ischemic outcomes
Endpoint
Aspirin
(N=2,307)
Placebo
(N=2,307)
HR
(95% CI)
Death/ischaemic events (%) 6.5 7.3 0.89 (0.71, 1.11)
Death (%) 3.1 3.4 0.91 (0.66, 1.26)
CV death (%) 2.3 2.5 0.92 (0.63, 1.33)
Stroke (%) 0.9 0.8 1.06 (0.56, 1.98)
Myocardial infarction (%) 2.9 3.6 0.81 (0.59, 1.12)
Definite or probable stent thrombosis (%) 0.5 0.9 0.52 (0.25, 1.08)
Urgent revascularisation (%) 1.6 2.0 0.79 (0.51, 1.21)
Hospitalisation (%) 25.4 23.4 1.10 (0.98, 1.24)
Aspirin vs placebo
recommended

Rate of Stent Thrombosis at 6 Months
According to Different Definitions
0
0.25
0.5
0.75
1
Definite
stent thrombosis
Definite/probable
stent thrombosis
KM
Rate
at
6
Months
n=20 n=30
Lopes et al. Circulation. 2020;141:781–783

Definite/Probable Stent Thrombosis According to
Antithrombotic Regimen
— VKA + Aspirin
— Apixaban + Aspirin
— VKA + No Aspirin
— Apixaban + No Aspirin
“There is limited experience of
coadministration with other platelet
aggregation inhibitors (such as
GPIIb/IIIa receptor antagonists,
dipyridamole, dextran or sulfinpyrazone)
or thrombolytic agents.
As such agents increase the bleeding
risk, coadministration of these products
with apixaban is not
recommended

Endpoint
Aspirin
(N=2,277)
Placebo
(N=2,279)
HR
(95% CI)
ISTH major or CRNM
bleeding, n (%)
367
(16.1)
204
(9.0)
1.89
(1.59, 2.24)
Definite or probable
stent thrombosis, n (%)
11
(0.63)
19
(1.08)
0.58
(0.28, 1.22)
AUGUSTUS:
Bleeding Events vs Stent Thrombosis Events
Bleeding events are much more common
than stent thrombosis events in AUGUSTUS
NNT at 6 months: 222
NNH at 6 months: 41 (major bleeding)
NNT at 1 month: 176
NNH at 1 month: 100 (major bleeding)
NNH: Number needed to harm
recommended

TILL WHAT TIME PERIOD DOES THE
REMOVAL OF ASPIRIN INFLUENCE
ISCHEMIC OUTCOMES?
How early we can stop? Or
To continue indefinitely?
Is there an Answer?

Ischemic Events With Placebo vs. Aspirin
• Though not statistically significant, there were numerically more of some ischemic
events in patients assigned placebo than aspirin:
Aspirin Placebo
• Death 72 (3.1%) vs. 79 (3.4%)
• Cardiovascular Death 53 (2.3%) vs. 58 (2.5%)
• Stroke 20 (0.9%) vs. 19 (0.8%)
• Stent thrombosis (definite or probable) 11 (0.5%) vs. 21 (0.9%)
• Myocardial infarction 68 (2.9%) vs. 84 (3.6%)
• Urgent revascularization 37 (1.6%) vs. 47 (2.0%)
Adapted from: Lopes RD, et al. N Engl J Med 2019;380:1509-24
• Analysis of the stent thrombosis events suggested that most of the increased risk was early, within 30
days of randomization
Lopes RD, et al. Circulation 2020; 141:781-783

Tradeoff Between Bleeding and Ischemic Events
There is a temporal component to the
balance of bleeding and ischemic risk
• Recurrent ischemic events (specifically
stent thrombosis) tend to occur early
after PCI
• Bleeding risk is cumulative and is
higher with long-term, potent
antithrombotic therapy
Schomig A, et al. Heart 2009;95:1280–1285

Severe Bleeding and Ischemic Outcomes
Randomization to 30 Days
Fatal, ICH, Major Bleeding CV Death, Stroke, MI, Stent Thrombosis
Alexander et a Circulation. 2020;141:1618–1627

Severe Bleeding and Ischemic Outcomes
30 Days to 6 Months
Fatal, ICH, Major Bleeding CV Death, Stroke, MI, Stent Thrombosis
Alexander et a Circulation. 2020;141:1618–1627

Conclusion
recommended
Apixaban LPDELI052021 (Version no. 13), dated 17th June 2021 Lopes RD, et al. N Engl J Med 2019;380:1509–24
• Among patients with AF and recent PCI including current generation of drug-
eluting stent, definite or probable stent thrombosis is rare and occurs more
frequently early after PCI.
• These data support the use of Apixaban and a P2Y12 inhibitor without aspirin
during the first 6 months for most patients, considering the almost 2-fold
increase in bleeding with aspirin use.
• In patients with a high risk of stent thrombosis and an acceptable risk of
bleeding, using aspirin up to 30 days after PCI should be considered. Further
studies to identify patients who might benefit the most from this strategy are
warranted.

Finding the Antithrombotic Sweet Spot
Antithrombotic
Sweet Spot
Risk of
Ischemic Events
Risk of
Bleeding Events
The right combination of antithrombotic agents at the
right dose and duration to reduce ischemic events as
much as possible at a minimal cost of bleeding
Lopes RD et.al. Eur Heart J 2019 Dec
7;40(46):3768-3770

2019 ESC Guidelines-management of chronic
coronary syndromes
CCS - Chronic Coronary
Syndrome
AF - Atrial Fibrillation
Knuuti et al. Eur Heart J 2020 Jan

2019 AHA/ACC/HRS Focused Update
January CT et al; J Am Coll Cardiol 2019 Jul 9;74(1):104-132
Dropping ASA is recommended for AF/ACS patients
…but, the strength of recommendation and quality of evidence are both only moderate.

2020 ESC AF Guideline AF and ACS/PCI
CAD – Coronary Artery Disease
Hindricks et al. European Heart Journal, Volume 42, Issue 5, 1 February 2021, Pages 373–498

2020 ESC AF Guideline AF and ACS/PCI:
Recommendations for patients with AF and an ACS, PCI, or CCS
Hindricks et al. European Heart Journal, Volume 42, Issue 5, 1 February 2021, Pages 373–498

Patient
• Aspirin 75mg OD
• Clopidogrel 75mg OD
• Apixaban 5mg BD for a month
Thereafter
• Clopidogrel 75mg OD
• Apixaban 5mg BD

TAKE HOME MESSAGE
• 1.AF with PCI is a double edged sword, most of the patients have multiple
comorbidities keeping them at risk of bleeding events as same as thrombotic
events.
• 2.These patients should be given Dual Inhibition for duration depending on
their risk and thereafter to continue single antiplatelet and NOACs.
• 3.NOACs are proven to be noninferior to warfarin in AF and PCS cases and
are more useful conventionally with no monitoring.
• 4.Cost factor and Availability of Ideal reversal agent is the issue with NOACs.
• 5.Subset of patients with VHD, Prosthetic valve and having ACS to be
evaluated in trials..

Management of AF patients with ACS undergoing PCI.pptx

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