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AF in ACS patients: what is the evidence of management
- 2. •5% of ACS patients undergoing PCI have concomitant AF …Rubboli et al., J Interv Cardiol 2009 • 15% of AF patients have a history of MI •AF confers mortality & morbidity risk from thromboembolism …Krijthe BP., Eur Heart J 2013 •ISAR trial (NEJM 1996) *ACS patients undergoing PCI *combined antiplatelet therapy as compared to anticoagulation -reduces incidence of cardiac events -lesser haemorrhagic complications
- 4. Antithrombotic therapy + dual antiplatelet therapy…haemorrhagic risk VS AF-related ischaemic stroke and Stent thrombosis
- 5. Clinical risk scores for bleeding: Class IIa (B) HAS-BLED Hypertension Abnormal renal/liver function (1 point each) Stroke Bleeding history or predisposition Labile INR Elderly (>65 years) Drugs/alcohol concomitantly (1 point each)], ORBIT (Outcomes Registry for Better Informed Treatment of Atrial Fibrillation) ATRIA Score ABC score (age, biomarkers, clinical history)
- 10. Primary outcome: any bleeding episode within 1 year of PCI
- 11. PIONEER AF PCI: AF + NOAC + PCI + DAPT
- 13. PIONEER–AF-PCI… not powered to detect differences in stroke rates Uncertain if rivaroxaban 2.5 mg b.i.d. would adequately reduce strokes in AF, even when combined with antiplatelet agents No reliable information regarding optimal duration of antiplatelet therapy
- 14. RE-DUAL PCI: dual antithrombotic therapy with dabigatran after percutaneous coronary intervention in patients with atrial fibrillation
- 15. R Randomiza tion ≤120 hours post-PCI* 6-month minimum treatment duration with visits every 3 months for the first year, then visits and telephone contact alternating every 3 months and a 1-month post-treatment visit Patients with AF undergoi ng PCI with stenting Dabigatran 150 mg BID + P2Y12 inhibitor Dabigatran 110 mg BID + P2Y12 inhibitor Warfarin (INR 2.0–3.0) + P2Y12 inhibitor + ASA N=27 25 Mean duration of follow-up: ~14 months
- 16. In patients with AF who have undergone PCI: Dual therapy with dabigatran and a P2Y12 antagonist significantly reduced the risk of bleeding versus warfarin triple therapy, with non-inferiority for overall thromboembolic events Absolute risk reductions with dabigatran dual therapy were 11.5% and 5.5% in major or clinically relevant non-major bleeding at the 110 mg and 150 mg doses, respectively, compared with warfarin triple therapy
- 17. • 4600 participants, 650 sites, 30 countries • comparing Open Label apixaban 5 mg BID vs warfarin (INR 2-3) Apixaban in AF (CHADS ≥1) + PCI or ACS planned P2Y12 x ≥6 months ↓ Randomized (Aspirin 81mg±placebo) ↓ Apixaban 5mg BID+P2Y2 ↔ VKA+P2Y2 …..ONGOING TRIAL
- 19. Warfarin (INR 2.0–3.0) Low-dose Edoxaban 30* mg QD High-dose Edoxaban 60* mg QD *Dose reduced by 50% if: - CrCl 30–50 mL/min - weight ≤60 kg - strong P-gp inhibitor 1º Efficacy EP = Stroke or SEE 2º Efficacy EP = Stroke or SEE or CV mortality 1º Safety EP = Major Bleeding (ISTH criteria) Non-inferiority Upper 97.5% CI <1.38 CI = confidence interval; CrCl = creatinine clearance; ISTH=International Society on 3Ruff CR et al. Am Heart J 2010; 160:635-41.Thrombosis and Haemostasis; P-gp = P-glycoprotein; SEE=systemic embolic event 21,105 PATIENTS AF on electrical recording within last 12 m CHADS2 ≥2 RANDOMIZATION 1:1:1 randomization is stratified by CHADS2 score 2–3 versus 4–6 and need for edoxaban dose reduction* Double-blind, Double-dummy
- 20. Both regimens significantly reduced Major bleed….20%/53% Haemorrhagic stroked….46%/67% Compared to warfarin gp (68.4%)
- 21. 97% patients were taking aspirin81% patients were taking aspirin plus a P2Y12-receptor inhibitor (predominantly clopidogrel)
- 24. Thank you.