ANTIPLATELET THERAPY ALONE OR WITH

ANTICOAGULATION IN AF PATIENTS WITH STABLE CAD

• Danish AF registry (n =8,700 AF patients with CAD):

– Stable CAD = no recurrent MI or stable/unstable angina for ≥360 days

– Mean follow-up: 3.3 years

MI/coronary death Thromboembolism* Fatal/non-fatal bleeding

HR (95% CI) HR (95% CI) HR (95% CI)

0.5 1.0 1.5 2.0 2.5 3.0 0.5 1.0 1.5 2.0 2.5 3.00.5 1.0 1.5 2.0 2.5 3.0

VKA + ASA + clopidogrel

VKA + clopidogrel

VKA + ASA

VKA

ASA + clopidogrel

Clopidogrel

ASA

Treatment regimen

Lamberts M. Circulation 2014;129:156771585

REGISTRIES ON VKA PLUS ASPIRIN VS VKA ALONE

IN AF AND STABLE CORONARY DISEASE

Dauerman HL. J Am Coll Cardiol 2014;64:1437:1440

DUAL VS TRIPLE THERAPY IN AF AFTER PCI FOR MI

Lamberts M. J Am Coll Cardiol 2013;62:981-989

n= 12,165

|

Primary Endpoint: Total number of bleeding events

WOEST

Days

Cum

ula

tive

incid

en

ce o

f b

lee

din

g

0 30 60 90 120 180 270 365

0 %

10 %

20 %

30 %

40 %

50 %

284 210 194 186 181 173 159 140n at risk:

279 253 244 241 241 236 226 208

Triple therapy group

Double therapy group 44.9%

19.5%

p<0.001

HR=0.36 95%CI[0.26-0.50]

NNT = 4

Lancet 2013:381:1107-1115

J Am Coll Cardiol 2015;65:1619–1629

TRIPLE THERAPY IN AF AND PCI FOR 6 WKS VS 6 MOS: ISAR-TRIPLE

PIONEER AF-PCI

• Primary endpoint: TIMI major, minor, and bleeding requiring medical attention

• Secondary endpoint: CV death, MI, stroke, and stent thrombosis

*XARELTO® 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).

Data on File. Janssen Pharmaceuticals, Inc.

2100

patients

with NVAF

No prior

stroke/TIA

PCI with

stent

placement

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

Clopidogrel 75 mg qd†

Aspirin 75-100 mg qd‡

VKA (target INR 2.0-3.0)

Aspirin 75-100 mg qd

VKA (target INR 2.0-3.0)

Clopidogrel 75 mg qd†

Aspirin 75-100 mg qd

≤72

hours

After

Sheath

removal

1,6, or 12 months

End oftreatment at12 months

AUGUSTUS TRIAL: APIXABAN IN AF/ACS

Patients (n4500) w/ AF (CHADS ≥1) + PCI or ACSPlanned P2Y12 x ≥6 months

Apixaban 5.0 (2.5*) mg BID+ P2Y12

VKA (INR 2-3)+ P2Y12

Randomize

Randomize

Aspirin81 mg QD

AspirinPlacebo

Primary: ISTH Major or CRNM Bleeding at 6 monthsSecondary: Death, MI, stroke, stent thrombosis at 6 months

2 x 2 Factorial

*2.5 mg BID for pts with 2/3: age >80 yrs, wt <60 kg, Cr >1.5 mg/dl