Triple Therapy After PCI in AF: A Quagmire Soon to be Drained Freek - - PowerPoint PPT Presentation

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Triple Therapy After PCI in AF: A Quagmire Soon to be Drained Freek - - PowerPoint PPT Presentation

Dec 10, 2023 376 likes •650 views

Triple Therapy After PCI in AF: A Quagmire Soon to be Drained Freek W.A. Verheugt Department of Cardiology, Onze Lieve Vrouwe Gasthuis (OLVG) Amsterdam, Netherlands D ISCLOSURES FOR F REEK W. A. V ERHEUGT Research support/ Bayer HealthCare,

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Freek W.A. Verheugt

Department of Cardiology, Onze Lieve Vrouwe Gasthuis (OLVG) Amsterdam, Netherlands

Triple Therapy After PCI in AF: A Quagmire Soon to be Drained

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Research support/ principal investigator Bayer HealthCare, Boehringer Ingelheim, Eli Lilly and Roche Consultant Bayer Healthcare, Eli Lilly, Daiichi-Sankyo, and Merck Speakers’ bureau none Honoraria Bayer Healthcare, Eli Lilly, Daiichi-Sankyo and Merck Scientific advisory board AstraZeneca and Cardialysis B.V.

DISCLOSURES FOR FREEK W. A. VERHEUGT

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Benefit and risk in registries Guidelines Benefit and risk in randomized controlled trials Future perspectives

Triple Therapy in Stented Patients

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Benefit and risk in registries Guidelines Benefit and risk in randomized controlled trials Future perspectives

Triple Therapy in Stented Patients

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Risk of Triple Therapy on Bleeding in 82,854 Danish AF Patients

Hansen ML. Arch Intern Med. 2010;170:1433-1441

(15%)

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Hansen ML. Arch Intern Med 2010;170:1433-1441

Benefit of Triple Therapy on Stroke in 82,854 Danish AF Patients

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Sorensen R. Lancet 2009; 374: 1967–1974

40,812 MI patients in Denmark with a follow-up of 16 months

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Bleeding in Stable Coronary Disease: CORONOR Registy

Hamon M. J Am Coll Cardiol 2014;64:1430-1436

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Ischemic Endpoints in Stable Coronary Disease: CORONOR Registy

Hamon M. J Am Coll Cardiol 2014;64:1430-1436

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Dual vs Triple Therapy after Stenting in AF

Rubboli A. Clin Cardiol 2014;37:357-364

(n = 67) (n = 162) (n = 679)

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ASPIRIN USE IN ORBIT-AF

Steinberg BA. Circulation 2013;128:721-728

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Benefit and risk in registries Guidelines Benefit and risk in randomized controlled trials Future perspectives

Triple Therapy in Stented Patients

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J Am Coll Cardiol 2015;65:1619–1629

Triple Therapy in AF and PCI for 6 wks vs 6 mos: ISAR-TRIPLE

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J Am Coll Cardiol 2015;65:1619–1629

Triple Therapy in AF and PCI for 6 wks vs 6 mos: ISAR-TRIPLE

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|

Primary Endpoint: Total number of bleeding events

WOEST

Days Cumulative incidence of bleeding 30 60 90 120 180 270 365 0 % 10 % 20 % 30 % 40 % 50 % 284 210 194 186 181 173 159 140 n 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

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Locations of TIMI bleeding: Worst bleeding per patient

WOEST

(n=) 3 3 16 20 25 7 30 20 48 8

p<0.001 p<0.001 p<0.001

5 10 15 20 25 30 35 40 45 50

Intra- Cranial Acces site GI Skin Other

Double therapy group Triple therapy group

`p = NS `p = NS

Lancet 2013:381:1107-1115 Lancet 2013:381:1107-1115

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Secondary Endpoint

1 2 3 4 5 6 7 8 9

Death MI TVR Stroke ST

Double therapy group Triple therapy group

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

2.6 6.4 3.3 4.7 7.3 6.8 1.1 2.9 1.5 3.2

p=0.027 p=0.382 p=0.128 p=0.165

WOEST

p=0.876

Lancet 2013:381:1107-1115 Lancet 2013:381:1107-1115

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DUAL VS TRIPLE THERAPY IN AF AFTER PCI FOR MI

Lamberts M. J Am Coll Cardiol 2013;62:981-989 n= 12,165

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Benefit and risk in registries Guidelines Benefit and risk in randomized controlled trials Future perspectives

Triple therapy in Stented Patients

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ACC/AHA Guidelines on AF. Circulation 2014;130:2071-2104

Dual Therapy in AF and PCI

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Lip GHY. Eur Heart J 2014;35:3155-3179

O A C A C A C A C O C O A C O A or C

Triple or dual therapy Dual therapy Dual therapy

  • r

DAPT

  • r

DAPT

  • r

DAPT

O

Monotherapy‡

O A C O A C O A or C O A or C

Triple or dual therapy Triple or dual therapy Dual therapy Dual therapy

O

Monotherapy‡

OAC ASA 75–100 mg daily Clopidogrel 75 mg daily STEP 1: stroke risk STEP 2: bleeding risk STEP 3: antithrombotic therapy

Time from PCI/ACS

Lifelong 12 months 6 months 4 weeks

CHA2DS2-VASc = 1 CHA2DS2-VASc ≥2

Low to intermediate (e.g. HAS-BLED = 0–2) High (e.g. HAS-BLED ≥3) Low to intermediate (e.g. HAS-BLED = 0–2) High (e.g. HAS-BLED ≥3)

Global Consensus: Antithrombotic Therapy for PCI in Patients with AF and Stable CAD

ESC Guidelines Revascularisation. Eur Heart J 2014;35:2541-2619

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Antithrombotic Therapy in Patients with AF and ACS

ESC Guidelines on NSTE-ACS. Eur Heart J 2016;37:267-315

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Benefit and risk in registries Guidelines Benefit and risk in randomized controlled trials Future perspectives

Triple Therapy in Stented Patients

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  • 1. Gibson et al. Am Heart J. 2015;169:472-478.e5; 2. Clinicaltrials.gov

identifier: NCT02164864; 3. RE-DUAL PCI. http://www.hcri.harvard.edu/research/trials/re-dual_pci;

  • 4. Clinicaltrials.gov identifier: NCT02415400.

Prospective trials of NOACs in NVAF patients with concomitant ACS or undergoing PCI are ongoing

RE-DUAL PCI (dabigatran)

2,500 NVAF patients with ACS or PCI

AUGUSTUS (apixaban)

4,600 NVAF patients with ACS or PCI

Primary objective: To assess the safety of two rivaroxaban treatment strategies vs the combination of VKA with DAPT Primary endpoint: TIMI major, minor bleeding or bleeding requiring medical attention (through 12 months)

PIONEER AF-PCI (rivaroxaban)

2,100 NVAF patients with PCI

Primary objective: To show non- inferiority of two different doses of dabigatran (150mg BD and 110 mg BD) + single antiplatelet therapy (clopidogrel or ticagrelor) vs the combination of warfarin + DAPT Primary endpoint: ISTH major bleeding (even-driven) Primary objective: To show non-inferiority of apixaban vs VKA in patients with concomitant P2Y12 inhibitor therapy and To show superiority of anticoagulant (VKA or apixaban) plus single antiplatelet therapy (P2Y12 inhibitor) vs anticoagulant plus DAPT (P2Y12 inhibitor + ASA) Primary endpoint: major/clinically relevant bleeding (through 6 months)

R

Rivaroxaban 15 mg OD* + P2Y12 inhibitor

Rivaroxaban 2.5 mg BD + DAPT (P2Y12 inh. + ASA) (for 1, 6 or 12 months)

VKA + DAPT (for 1, 6 or 12 months) Rivaroxaban 15 mg OD + ASA VKA + ASA

12-month open-label treatment period *Rivaroxaban 10 mg OD in patients with CrCl 30-50 ml/min †Apixaban 2.5 mg BD in selected patients.

#ASA will be given for 1 month post-BMS and 3

months post-DES

R

Apixaban 5 mg BD† + P2Y12 inhibitor VKA + P2Y12 inhibitor + ASA + placebo

6-month treatment period (ASA given double- blinded)

+ ASA + placebo

R R

ASA for all

  • n day
  • f

ACS/P CI

R

Dabigatran 150 mg BD + clopidogrel/ticagrelor Dabigatran 110 mg BD + clopidogrel/ticagrelor VKA + clopidogrel/tic agrelor + ASA (for 1-3 m)#

Open-label treatment period for up to 30m

VKA + clopidogrel/ ticagrelor

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Triple therapy (OAC, clopidogrel and aspirin) for PCI in AF leads to unacceptable bleeding. Possibly, aspirin may be skipped The most recent guidelines mandate for most AF patients undergoing PCI triple therapy for the shortest period as clinically acceptable. For AF patients undergoing PCI the NOACs seem preferable because of their safety profile, but randomized trial data are necessary to support this 1. 2. 3. Take Home Messages

Triple Therapy in Stented Patients