TERAPIA ANTITROMBOTICA NELLA SCA IN PAZIENTI CON FA CRONICA

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1 TERAPIA ANTITROMBOTICA NELLA SCA IN PAZIENTI CON FA CRONICA Dr.ssa Patrizia Noussan Ospedale San Giovanni Bosco Torino Cardio Alessandria giugno 2015

2 FA permanente e SCA una associazione pericolosa.. Prevalenza di FA 1-2% L 80%dei pazien; in FA ha indicazione a OAC Il 30% dei pazien; in FA ha una concomitante patologia vascolare e nel 20% andrà incontro a PTCA con impianto di stent In Europa 1-2 milioni di pazienk in OAC potrebbero avere indicazione a una PTCA con stenkng

3 ReccomendaKon for ankthrombokc therapy in ACS-NSTE e STEMI pakents undergoing PCI

4 Primary end point : first occurrence of stroke, non-cns systemic embolus, AMI o vascular death

5 Kaplan-Meier Survival Curves in RelaKon to AnKcoagulaKon Use at Discharge (J Am Coll Cardiol 2008;51:818 25)

6 Risk of Bleeding With Single, Dual, or Triple Therapy With Warfarin, Aspirin, and Clopidogrel in PaKents With Atrial FibrillaKon Arch Intern Med. 2010;170(16): !

7 TRIPLE THERAPY (TT) ASA + P2Y12 I + OAC (VKA/NOACS) 4-16% rischio di sanguinamen; Bleeding complicakons ThromboKc complicakons Stroke stent thrombosis DUAL THERAPY OAC+ SINGLE ANTIPLATELET 50% i sanguinamenk

8 2010

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10 The WOEST Trial: First randomised trial comparing two regimens with and without aspirin in pakents on oral ankcoagulant therapy undergoing coronary stenkng 1:1 Randomisa5on: Double therapy group: OAC + 75mg Clopidogrel qd Study Design Triple therapy group OAC + 75mg Clopidogrel qd + 80mg Aspirin qd 1 month minimum aser BMS 1 year aser DES 1 month minimum aser BMS 1 year aser DES Follow up: 1 year Primary Endpoint: The occurence of all bleeding events (TIMI criteria) Secondary Endpoints: - CombinaKon of stroke, death, myocardial infarckon, stent thrombosis and target vessel revascularisakon - All individual components of primary and secondary endpoints

11 Primary Endpoint: Total number of TIMI bleeding events 50 % Triple therapy group Double therapy group 44.9% Cumula;ve incidence of bleeding 40 % 30 % 20 % 19.5% 10 % 0 % p<0.001 HR= %CI[ ] Days n at risk:

12 % WOEST p< TIMI Minimal Primary Endpoint: Bleeding events TIMI classifica;on p< p= p< TIMI Minor TIMI Major Any TIMI bleeding Double therapy group Triple therapy group

13 Conclusions 1. First randomized trial to address the opkmal ankplatelet therapy in pakents on OAC undergoing coronary stenkng 2. In this study which was specifically designed to detect bleeding events, the bleeding rate was higher than expected 3. Primary endpoint was met: OAC plus clopidogrel causes less bleeding than triple ankthrombokc therapy, but now shown in a randomized way 4. Secondary endpoint was met: with double therapy there is no excess of thrombokc/ thromboembolic events: stroke, stent thrombosis, target vessel revascularisakon, myocardial infarckon or death 5. Less all-cause mortality with double therapy LimiK : Numerosità del campione (576 pts) - 69% dei pazienk era in OAC per FA accesso femorale nel 74% - PCI elejva nel 70-75% - uso non rouknario di PPI - TT per 12 mesi

14 JACC Vol. 62, 2013;62:

15 In real life AF pakents with indicakons for mulkple ankthrombokc drugs aker MI/PCI, OAC and clopidogrel was equal or bemer on both benefit and safey outcomes compared to triple therapy

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17 STEMI pakents

18 ACS - NSTE pakents Ø Principals aspects of the ESC guidelines are considered in the responding centres Ø Uncertainty in the issue of opkmal composikon and durakon of mulkple ankthrombokc treatment and the opkmal regimen(s) of NOACS in treatment strategies

19 2014

20 To evaluate wether shortening the durakon of clopidogrel therapy from 6 months to 6 weeks aker DES implantakon was associated with a superior net clinical outcome in pakents receiving concomitant aspirin and OAC The study will test the hypotesis that DAPT compared with TT with non valvular AF at low to moderate risk of stroke CHADS2 <2 aker PCIS reduces the risk of bleeding and is not inferior to TT for prevenkng thromboembolic complicakons

21 Primary End point: a composite of Death, MI, def ST, stroke or TIMI major bleeding at 9months

22 NOACs Il ruolo dei NOACs nei pazien; con FA e ACS non è stato valutato direeamente ma deriva sopraeueo da analisi post-hoc o da RCTs sull u;lizzo dei NOACs in associazione alla terapia an;aggregante nei pazien; ACS-PCI Quando si u;lizza un NOAC in associazione a clopidogrel o bassa dose di ASA, la dose di NOAC da u;lizzare è la più bassa testata negli studi di prevenzione dello stroke nella FA Una recente metanalisi non ha evidenziato differenze nell incidenza di IMA tra NOACs e Warfarin NOACs trial in corso : PIONEER AF-PCI RE-DUAL PCI

23 Conclusions: Rates of thrombokc and bleeding events were similar in pakents with TT and pakents with Ticagrelor and warfarin

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25 Consensus recommendakon Nei pazien; con FA non valvolare u;lizzare gli score di rischio CHA2DS2-VASC e Has-BLED e GRACE Risk per la stra;ficazione del rischio ACS Se OAC è VKA à TTR>70% con INR clopidogrel e/o ASA ( mg) (IIa, C) se in associazione a SE OAC è NOAC, deve essere u;lizzata la posologia più bassa disponibile ma risultata efficace nella prevenzione dello stroke à Dabigatran 110 b.i.d Rivaroxaban 15mg o.d. Apixaban 2.5 mg b.i.d. (IIb, C) Nei pazien; con FA non valvolare e coronaropa;a stabile > 12 mesi mantenere VKA o NOAC (IIa, B). In casi seleziona;(ptca di Tc, IVA prossimale, biforcazioni, IMA ricorren; ) si può considerare un prolungamento della duplice terapia (IIb,B) Accesso radiale, new genera;on DES vs BMS NO Prasugrel e Ticagrelor nella TT (III, C)

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