Strategia antitrombotiche nel paziente con fibrillazione atriale sottoposto a PCI

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Margherita Perini
6 anni fa
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1 Strategia antitrombotiche nel paziente con fibrillazione atriale sottoposto a PCI Andrea Rubboli U.O. Cardiologia - Laboratorio di Emodinamica Ospedale Maggiore, Bologna Nucleus Working Group Thrombosis - ESC Direttivo Gruppo ATBV

2 DISCLOSURE INFORMATION Andrea Rubboli Dichiaro che negli ultimi due anni ho avuto i seguenti rapporti anche di finanziamento con soggetti portatori di interessi commerciali in campo sanitario: Astra Zeneca Bayer Boehringer Ingelheim Daiichi Sankyo Pfizer BMS

3 Need to prevent Stroke Recurrent ischemic events + stent thrombosis Bleeding

4 PCI DAPT (ASA + P2Y12 inhibitor) Stronger Recurrent ischemic events + stent thrombosis Weaker Weaker Stroke Stronger OAC AF

5 Recommendation: 1. Triple therapy of OAC, aspirin, and clopidogrel (Class IIa; LOE C) Lip GY et al. Eur Heart J 2014;35:

6 Triple therapy (warfarin) vs. DAPT MACE = CV death + MI + thromboembolism Singh PP et al. Ther Adv Cardiovasc Dis 2011;5:23-31

7 Bleeding avoiding strategies 1. limit peri-procedural bleeding* 2. reduce intensity of (warfarin) OAC** 3. avoid newer P2Y12 inhibitors (i.e., prasugrel, ticagrelor) in triple therapy 4. limit duration of triple therapy 5. reduce intensity of antithrombotic therapy # (?) * radial approach, uninterrupted warfarin OAC, no GP IIb/IIIa inhibitors ** target INR # by withdrawing aspirin

8 Dual vs. triple therapy: the WOEST study 1 endpoint - Safety (total bleeding) 2 endpoint - Efficacy (stroke, death, MI, re-pci/cabg, stent thrombosis) Dewilde WJ et al. Lancet 2013;381:

9 Lo studio WOEST Sicurezza Efficacia Trascinata da emorragie NON maggiori Trascinata da mortalità NON cardiaca Sottodimensionato per trombosi di stent Rubboli A, Limbruno U. G Ital Cardiol 2013;14:564-8

10 Recommendations: 1. Triple therapy of OAC, aspirin, and clopidogrel (Class IIa; LOE C) 2. Dual therapy of OAC, and clopidogrel (Class IIb; LOE C) selected pts. at high bleeding risk and low risk of stent thrombosis/recurrent ischemic events Lip GY et al. Eur Heart J 2014;35:

11 PIONEER AF-PCI trial Group 1: rivaroxaban 15 mg OD + P2Y12 inhibitor; Group 2: rivaroxaban 2.5 mg BID + DAPT Group 3: adjusted-dose VKA (INR ) + DAPT Clinically significant bleeding (%) MACE (%) Group 1 vs. 3: HR 0.59 (95% CI, ); p<0.001 Group 2 vs. 3: HR 0.63 (95% CI, ); p<0.001 Group 1 vs. 3: HR 1.08 (95% CI, ); p=0.75 Group 2 vs. 3: HR 0.93 (95% CI, ); p=0.76 Day Day Gibson CM et al. N Engl J Med 2016;375:

12 PIONEER AF-PCI trial: main limitations 1. individual efficacy end-points comparable among treatment Groups 2. rivaroxaban 15 mg OD dose not approved for clinical use 3. stroke rate significantly higher in Group 2 vs. 3 (when DAPT given for 6 mos.) 4. imbalance in pts. characteristics across treatment Groups 5. stent thrombosis not adjudicated by core laboratory Gibson CM et al. N Engl J Med 2016;375:

13 2014 ESC/EACTS guidelines on myocardial revascularization Recommendations Class Level In patients with ACS and atrial fibrillation.. triple therapy of (N)OAC and ASA ( mg/day) and clopidogrel 75 mg/day should be considered.. IIa C Dual therapy of (N)OAC and clopidogrel 75 mg/day may be considered as an alternative to initial triple therapy in selected patients. IIb B Adapted from Windecker S et al. Eur Heart J 2014;35:

14 A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE) Incidence of ischemic stroke + MI + vascular death CAPRIE Steering Committee. Lancet 1996;348:

15 IPA % (20 mm ADP) Prasugrel Loading Dose Prasugrel Maintenance Doses * * * * * * * * * * * * * Clopidogrel 600 mg/75 mg 50 Clopidogrel 300 mg/75 mg * p<0.001 Prasugrel vs Clopidogrel Prasugrel 60 mg/10 mg p<0.05 Clopidogrel 600 mg vs 300 mg p<0.001 Clopidogrel 600 mg vs 300 mg Data are expressed as mean ± SEM Pre-dose IPA Time Day 1 (hours) Days Payne CD et al. J Cardiovasc Pharmacol 2007;50:555-62

16 Wafarin and ticagrelor vs. triple therapy after ACS Braun OÖ et al. Thromb Res 2015;135:26-30

17 Ongoing trials on PCI in AF RE-DUAL PCI ENTRUST AF-PCI AUGUSTUS Dabigatran 110 mg BID + P2Y12 inhibitor * Dabigatran 150 mg BID + P2Y12 inhibitor * Edoxaban 60/30 mg + P2Y12 inhibitor ** Apixaban 5/2.5 mg Warfarin + BID + P2Y12 inhibitor** P2Y12 inhibitor ** Warfarin + P2Y12 inhibitor * + ASA Warfarin + P2Y12 inhibitor ** + ASA Apixaban 5/2.5 mg Warfarin + BID + P2Y12 inhibitor ** P2Y12 inhibitor ** + ASA + ASA * clopidogrel/ticagrelor; ** clopidogrel/prasugrel/ticagrelor

18 Conclusioni Nel paziente con fibrillazione atriale sottoposto a PCI: il regime antitrombotico generalmente raccomandato è triplice terapia * durante triplice terapia, vanno attuate misure per contenere rischio emorragico può essere considerata in casi selezionati duplice terapia ** si attendono risultati di studi in corso circa possibili ulteriori regimi antitrombotici * warfarin/nao + aspirina + clopidogrel ** warfarin/nao + clopidogrel

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