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Highest bleeding rate with triple therapyDanish cohort of 82854 patients with AF followed for an average of 3.3 years Significant bleeding rate with triple therapy was 15.7 per 100 pati

• 79 years- old lady

• BMI 22

• Hypertension

• Dyslipidemia

• PCI (DES LAD Jan 2015)

• High risk UA- TIMI 5

– Ticagrelor 90 bid – Metoprolol succinate 25mg

qd – ISMN 60mg qd – Furosemide/ Spironolactone 10/25mg qd

– Rosuvastatin 20mg qd – Trimetazidine 35mg bid

On admission ECG

Sinus rhythm 85 bpm, normal QRS axis and PR interval

ST-T depression 1-2 mm in DI, DII, V1-V4

Coronary angiogram

1 Patent LAD stent No ISR

2 Diffused LCx (small vessel)

3 Total occlusion RCA

For RCA CTO intervention

Post PCI- CCU f/u

AF and ACS/PCI

Lip et al Eur Heart J 2014;35:3155-3179

ACS/PCI AF

• Essential to prevent stent thrombosis post PCI

• ≥12 months

Triple Rx

• By what medications?

• For how long?

• How much data do we have?

Anti-thrombotic therapy for ACS/PCI plus AF

Highest bleeding rate with triple therapy

Danish cohort of 82854 patients with AF followed for an average of 3.3 years

Significant bleeding rate with triple therapy was 15.7 per 100 patient-year

Hansen et al Arch Intern Med 2010;170:1433-1441

Risk of stroke according to CHA2DS2-VASc

CHA 2 DS 2 -VASc criteria Score

Congestive heart failure/

left ventricular dysfunction 1

Vascular disease (prior myocardial

infarction, peripheral artery

disease, or aortic plaque) 1

Age 65–74 years 1

Sex c ategory (i.e female gender) 1

Lip G et al Chest 2010;137:263–72; Lip G et al Stroke 2010;41:2731–8;

ESC guidelines: Camm J et al Eur Heart J 2010;31:2369–429; Hart RG et al Ann Intern Med 2007;146:857–67

*Adjusted for warfarin use Theoretical rates without therapy; assuming that warfarin provides a 64% reduction in stroke risk, based on Hart RG et al 2007

TE = thromboembolism

Total score N stroke rate Adjusted

Risk of bleeding according to HAS-BLED

HAS-BLED risk criteria Score

Hypertension

Abnormal renal or liver

function (1 point each) 1 or 2

Available Data

Large RCT Smaller RCT Prospecitve Retrospective Meta-analysis

cohort cohort

None WOEST eg, eg, DANISH CHEN et al

AVIATOR (crude and Herz 2015

adjusted) ISAR GAO et al Clin TRIPLE Cardiol 2015

Triple versus dual anti-thrombotic

therapy in AF- ACS/PCI

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

Lancet 2013; 381: 1107–15

WOEST-Secondary and safety endpoints at 1 year

Lower mortality rate in double versus triple therapy

OBJECTIVES …Whether shortening the duration of clopidogrel

therapy from 6 months to 6 weeks after DES implantation was

associated with a superior net clinical outcome in patients receiving concomitant aspirin and OAC

METHODS… Randomized, open-label trial 614 patients receiving

6-week clopidogrel therapy (n= 307) or 6-month clopidogrel therapy (n=

definite ST, stroke, or TIMI major bleeding at 9 months

J Am Coll Cardiol 2015;65:1619–29

Main findings from ISAR- TRIPLE

(A)primary endpoint

(cumulative incidence of death, myocardial

infarction, stent

thrombosis, stroke or TIMI major bleeding)

(B)secondary ischemic

endpoint (cardiac death,

myocardial infarction, stent thrombosis, or

ischemic stroke)

J Am Coll Cardiol 2015;65:1619–29

 No difference in TIMI major

bleeding between the 2

groups (5.3%vs 4.0%; HR:

1.35; 95% CI: 0.64 to 2.84; p= 0.44)

 Any BARC bleeding occurred

in 114 patients in the 6-week group and 122 patients in the 6-month group

(HR:0.94;95%CI:0.73to1.21; p= 0.63)

 Intracranial bleeding

frequency was low

Bleeding in ISAR- TRIPLE

J Am Coll Cardiol 2015;65:1619–29

1 Compare efficacy and safety

outcomes of triple therapy vs dual

therapy (clopidogrel with aspirin or

OAC)

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 (March 2015)

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:

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

Conclusion

 In patients taking oral anticoagulants and undergoingPCI , 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 (March 2015)

Herz (July 2015),DOI 10.1007/s00059-015-4325-0

1 23 clinical trials comprised 22,212 participants

2 TT was more efficacious than DT (DAPT or OAC + single APT) in reducing MACE/stroke (RR =0.76, 95% CI: 0.70–0.83; p< 0.00001 &

RR = 0.67,95% CI: 0.59–0.75; p< 0.00001, respectively)

3 There was a significant reduction in all-cause death in the TT

compared with the DT regimen (RR = 0.64, 95 % CI: 0.56–0.73; p < 0.00001& RR = 0.48, 95 % CI: 0.39–0.58; p < 0.00001,respectively)

More major bleeding in patients receiving TT compared with DAPT (p < 0.00001), but…

No difference between those receiving TT and OAC + single antiplatelet agent (RR = 0.96; 95 % CI: 0.75–1.21; p = 0.71)

Herz (July 2015),DOI 10.1007/s00059-015-4325-0

Herz (July 2015),DOI 10.1007/s00059-015-4325-0

No differences in MACE/ Stroke & All- cause death

between TT and OAC+ clopidogrel

Management of antithrombotic therapy in AF patients presenting with ACS and/or undergoing PCI or valve interventions: a joint consensus document

European Heart Journal doi:10.1093/eurheartj/ehu298 (July 2014)

European Heart Journaldoi:10.1093/eurheartj/ehv320 (August 2015)

2015 ESC guidelines for the management of ACS in patients

presenting without persistent ST-segment elevation

Guidance for combination therapy in patients

with AF and ACS

Lip GYH et al Eur Heart J 2014;doi:10.1093/eurheartj/ehu298

1 In general, the period of triple therapy should be

as short as possible, followed by OAC plus a

single antiplatelet therapy (clopidogrel 75 mg/d,

or as an alternative, ASA 75–100 mg/d)

2 Long-term antithrombotic therapy with OAC

(beyond 12 months) is recommended in all

patients

3 Where a NOAC is used in combination with

clopidogrel and/or low-dose ASA, the lower

tested dose for stroke prevention in AF may be

considered

B

Level

I Class

C

IIb

General recommendation

XANTUS: Low rates of Bleeding and Stroke in a Real-World Prospective, Observational study of Patients Treated with Rivaroxaban for Stroke Prevention in Atrial Fibrillation

ESC 2015, London, UK

1 To collect real-life data on adverse events in patients with

non-valvular AF treated with rivaroxaban to determine its safety profile across the broad range of patient risk profiles encountered in

routine clinical practice

2 Primary outcomes: major bleeding, all-cause mortality, any

other adverse events

XANTUS results

European Heart Journal doi:10.1093/eurheartj/ehv466

Our patient treatment & Conclusions

1 CHA2DS2-VASc= 5 with High bleeding risk (HAS-BLED = 3) 

[Clopidogrel 75 mg + Aspirin 100 mg + Xarelto 15 mg daily] for 4 weeks (finished without any bleeding complication)

2 [Clopidogrel 75 mg + Xarelto 15 mg daily ] up to 12 months after PCI procedure (September 2016)- Xarelto for life after that

3 AF plus ACS/PCI: challenge clinical scenario that need careful

assessment for risk of embolic event (CHA2DS2-VASc score) and bleeding (HAS-BLED) to have appropriate anti-thrombotic therapy

Thank you for your attention!