IL PAZIENTE IN NAO CANDIDATO A PCI ELETTIVA E URGENTE SIMONA PIERINI

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1 IL PAZIENTE IN NAO CANDIDATO A PCI ELETTIVA E URGENTE SIMONA PIERINI

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3 Pazienti sottoposti a PCI con indicazione a terapia anticoagulante orale a lungo termine con VKA/NOACs

4 The anti-thrombotic dilemma in AF / CAD PCI and stenting in OAC Peri-procedural anticoagulation DAPT needed for ST prevention OAC needed for stroke prevention

5 European Heart Journal (2016) 37, doi: /euroheartj/ehv320

6 PCI PRIMARIA in pz in OAC: Approccio radiale!!! Sempre ANTICOAGULANTE AGGIUNTIVO per via parenterale, indipendentemente dal timing dell ultima somministrazione dell anticoagulante orale: Preferibile la BIVALIRUDINA per la breve emivita e il minor rischio emorragico, soprattutto nei pz in dabigatran Preferibile l ENOXAPARINA nei pz che assumono inibitori diretti del fattore Xa (apixaban rivaroxaban, edoxaban) Inibitori GP IIb/IIIa solo in bail-out.

7 PCI ELETTIVA in pz in OAC: Approccio radiale Non anticoagulante aggiuntivo in pz con VKA se INR > 2.5 Non discontinuare VKA/NOACs (per evitare bridging therapy che possono aumentare le complicanze emorragiche e tromboemboliche)??? Evitare gli inibitori GP IIb/IIIa (eccezione: bail-out) Rubboli A. et al, Thromb Haemost 2014; 112:

8 The anti-thrombotic dilemma in AF / CAD New antiplatelet agents DAPT needed for ST prevention PCI and stenting in OAC Post-PCI antithrombotic therapy Peri-procedural anticoagulation NOACs OAC needed for stroke prevention

9 FA e CAD: quale terapia antitrombotica post-pci? Triple therapy

10 Duplice vs triplice terapia antitrombotica Lancet 2013; 381:

11 Possibili cocktail terapeutici RISCHIO ISCHEMICO RISCHIO EMORRAGICO

12 Kirchhof P et al, Eur Heart J 2016 doi: /eurheartj/ehw210

13 Windecker Roffi M. S. et et al, al, Eur HeartJ J

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16 AF+PCI: A North American Perspective 2016 Update Pragmatic algorithm for the management of AF patients requiring OAC undergoing PCI Angiolillo DJ et al. Circ Cardiovasc Interv. 2016

17 AF+PCI: A North American Perspective 2016 Update Pragmatic algorithm for the management of AF patients requiring OAC undergoing PCI Angiolillo DJ et al. Circ Cardiovasc Interv. 2016

18 Angiolillo DJ et al. Circ Cardiovasc Interv. 2016

19 AF+PCI: A North American Perspective 2016 Update Angiolillo DJ et al. Circ Cardiovasc Interv. 2016

20 The anti-thrombotic dilemma in AF / CAD New antiplatelet agents DAPT needed for ST prevention PCI and stenting in OAC Newgeneration DES Post-PCI antithrombotic therapy Peri-procedural anticoagulation NOACs OAC needed for stroke prevention

21 Ischaemic risk according to DES type JAm Coll Cardiol 2015; 65: Eur Heart J 2016; 37:

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23 Is ASA Necessary in Triple Therapy? The WOEST Trial Cumulative incidence (%) Cumulative incidence (%) The modest-scale, open-label WOEST study (N=573) compared safety outcomes with triple therapy (VKA + clopidogrel + ASA) vs DAT (VKA + clopidogrel) 69% of WOEST patients had AF, included prosthetic heart valves 50 Safety outcomes 50 Efficacy outcomes * Underpowered to * 20 Power defining ischemic events 10 23% CV death 13.7% ** 30.6% 0 Any bleeding TIMI major TIMI major + minor Death MI Stroke Dropping ASA was associated with significantly lower rates of bleeding vs triple therapy, with a similar reduction in the rate of thrombotic events VKA + clopidogrel (DAPT) (n=279) VKA + clopidogrel + ASA (triple therapy) (n=284) *p<0.05; **all-cause death (CV death, p=0.207; non-cv death, p=0.069) Dewilde WJ et al. Lancet 2013;381:

24 Lip et al., Eur Heart J 2014

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26 New Engl J Med 2016; doi: /NEJMoa Design: An open-label, randomized, controlled phase IIIb safety study WOEST like ATLAS2 like Triple therapy *CrCl ml/min: 10 mg OD; # first dose hours after sheath removal; clopidogrel (75 mg daily) (alternative use of prasugrel or ticagrelor allowed, but capped at 15%); ASA ( mg daily) plus clopidogrel (75 mg daily) (alternative use of prasugrel or ticagrelor allowed, but capped at 15%); first dose hours after sheath removal 1. Janssen Scientific Affairs, LLC [accessed 10 Oct 2016]; 2. Gibson CM et al, Am Heart J 2015;169: e5; 3. Gibson CM et al, New Engl J Med 2016; doi: /NEJMoa

27 TIMI major, TIMI minor or bleeding requiring medical attention (%) Both Rivaroxaban Strategies was Associated With Significantly Improved Safety Rivaroxaban 15 mg OD plus single antiplatelet vs VKA plus DAPT: HR=0.59; (95% CI ); p<0.001 Rivaroxaban 2.5 mg BID plus DAPT vs VKA plus DAPT: HR=0.63 (95% CI ); p< % 18.0% 16.8% NNT= 12 ARR 9.9% NNT= Time (days) Group 3 (VKA plus DAPT) Group 2 (Rivaroxaban 2.5 mg BID plus DAPT) Group 1 (Rivaroxaban 15 mg OD plus single antiplatelet) Gibson CM et al, New Engl J Med 2016; doi: /NEJMoa ]

28 CV death, MI or stroke (%) Efficacy was Comparable Between All Three Treatment Strategies* Rivaroxaban 15 mg OD plus single antiplatelet vs VKA plus DAPT: HR=1.08; (95% CI ); p=0.750 Rivaroxaban 2.5 mg BID plus DAPT vs VKA plus DAPT: HR=0.93 (95% CI ); p= *Trial not powered to definitively demonstrate either superiority or non-inferiority for efficacy endpoints Time (days) 6.5% 6.0% 5.6% Group 3 (VKA plus DAPT) Group 2 (Rivaroxaban 2.5 mg BID plus DAPT) Group 1 (Rivaroxaban 15 mg OD plus single antiplatelet) Gibson CM et al, New Engl J Med 2016; doi: /NEJMoa

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30 Apixaban Versus Warfarin in Patients with AF and ACS or PCI: The AUGUSTUS Trial Inclusion AF (prior, persistent, or >6 hrs duration) Physician decision that oral anticoag is indicated ACS and/or PCI with planned P2Y12 inhibitor for 6 months Randomize n =4,600 Patients Exclusion Contraindication to DAPT Other reason for warfarin (prosthetic valve, mod/sev MS) Apixaban Warfarin P2Y12 inhibitor for all patients x 6 months Aspirin for all on the day of ACS or PCI Aspirin versus placebo after randomization ASA placebo ASA placebo Primary outcome: major/clinically relevant bleeding (through 6 months) Secondary objective: Death, MI, stroke, stent thrombosis

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32 CONCLUSIONI (1) Pazienti con indicazione a OAC a lungo termine e che richiedano anche una DAPT (o viceversa) non sono così infrequenti La TRIPLICE TERAPIA ANTITROMBOTICA è per il momento sicuramente il gold standard, ma fa aumentare il rischio di eventi emorragici maggiori La durata della triplice condiziona il rischio emorragico Gli stent di ultima generazione ci permettono di accorciare la durata della triplice

33 CONCLUSIONI (2) La triplice terapia antitrombotica con i NOACs è possibile (specie se di breve durata), visto il favorevole profilo di sicurezza di questi farmaci Cominciano a essere disponibili dati promettenti sulla DUPLICE TERAPIA ANTITROMBOTICA, con o senza NOACs I trials randomizzati in corso faranno chiarezza su quale sia la migliore strategia antitrombotica in questi pazienti?

34 How Many Patients Would it Take to Show Non- Inferiority in Ischaemic Stroke to Warfarin? About 19,000 Patients/Arm 19,225 patients per treatment arm would be needed to show noninferiority in ischaemic stroke with 90% power, 30% non-inferiority margin and a one-sided alpha of % non-inferiority margin means that the 95 th % of the confidence interval for NOAC must lie to left to be non-inferior NOAC better NOAC worse In PIONEER, power to show noninferiority in ischaemic stroke was 9% HR= % warfarin ischaemic stroke HR= % fold risk of ischaemic stroke to 1.56%

35 UNA SPERANZA SANCIRE IL DIVORZIO FRA DAPT E OAC

36 Emilio Scanavino: Tramatura