WOEST Presentation Slides

7/24/2019 WOEST Presentation Slides

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The WOEST Trial: First randomised trialcomparing two regimens with and without

aspirin in patients on oral anticoagulant therapyundergoing coronary stenting

Willem Dewilde, Tom Oirbans, Freek Verheugt, Johannes Kelder, Bart

De Smet, Jean-Paul Herrman, Tom Adriaenssens, Mathias Vrolix,Antonius Heestermans, Marije Vis, Saman Rasoul, Kaioum

Sheikjoesoef, Tom Vandendriessche, Kristoff Cornelis, Jeroen Vos,

Guus Brueren, Nicolien Breet, Jurrin ten Berg

The WOEST Trial= What is the Optimal antiplatElet and anticoagulanttherapy in patients with oral anticoagulation and coronary StenTing(clinicaltrials.gov NCT00769938)

Disclosures/Conflict of interest: none

WOEST ESC, Hotline III, Munchen, August 28th, 2012


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Background

1/ Long term oral anticoagulant therapy (OAC) is obligatory (class I) in:

- most patients with atrial fibrillation

- patients with mechanical heart valves

2/ Over 30% of these patients have concomitant ischemic heart diseaseWhen these patients need to undergo percutaneous coronary stenting,

there is also an indication for aspirin and clopidogrel

3/ Triple therapy (OAC, aspirin and clopidogrel) is recommended according

to the guidelines but is also known to increase the risk of major bleeding

Major bleeding increases mortality

4/ No prospective randomized data available

WOEST


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Aim of the study

To test the hypothesis that in patients on OAC undergoing

PCI, clopido gre l aloneis superior to the combination aspir in

and c lopidogre l with respect to bleeding but is not increasing

thrombotic risk in a multicentre two-country study (The

Netherlands and Belgium)

WOEST


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Study Design

1:1 Random isat ion:

Dual therapy group:

OAC + 75mg Clopidogrel qd

1 month minimum after BMS

1 year after DES

Triple therapy group

OAC + 75mg Clopidogrel qd + 80mg Aspirin qd

1 month minimum after BMS

1 year after DES

Follow up: 1 year

Pr imary Endpo int :The occurence of all bleeding events (TIMI criteria)

Second ary Endp oints :

-Combination of stroke, death, myocardial infarction, stent thrombosis and

target vessel revascularisation

- All individual components of primary and secondary endpoints

WOEST


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Primary Endpoint: Total number of bleeding events

WOEST

Days

Cumulativei

ncidenceofbleeding

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 groupDouble therapy group 44.9%

19.5%

p


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Locations of TIMI bleeding: Worst bleeding per patient

0

5

10

15

20

25

30

35

40

4550

Intra-

Cranial

Acces

site

GI Skin Other

Double therapygroup

Triple therapygroup

WOEST

(N=)

3 3

16

20

25

7

30

20

48

GI=gastro intestinal; Other bleeding consists of eye, urogenital, respiratory tract, retroperitoneal, mouth, PMpocket bleeding

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Secondary Endpoint

0

1

2

3

4

5

6

7

8

9

Death MI TVR Stroke ST

Doubletherapy group

Triple therapygroup

MI=any myocardial infarction; TVR= target vessel revascularisation (PCI + CABG); ST= stent thrombosis

2.6

6.4

3.3

4.7

7.36.8

1.1

2.9

1.5

3.2

p=0.027

p=0.382

p=0.128 p=0.165

WOEST

p=0.876


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Conclusions

1. First randomized trial to address the optimal antiplatelet therapy in

patients on OAC undergoing coronary stenting

2. Primary endpoint was met: as expected, OAC plus clopidogrel

causes less bleeding than triple antithrombotic therapy, but nowshown in a randomized way

3. Secondary endpoint was met: with dual therapy there is no excess

of thrombotic/thromboembolic events: stroke, stent thrombosis,target vessel revascularisation, myocardial infarction or death

4. Less all-cause mortality with dual therapy

WOEST


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Implications

We propose that a strategy of oral anticoagulants

plus clopidogrel, but without aspirin could be

applied in this group of high-risk patients on OAC

when undergoing PCI

WOEST

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