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NOAC in coronary artery disease
- 1. NOAC In CoronaryArtery Disease The Novel Shield ? Ahmed ElBorae, MSc Faculty of medicine, Cairo University Aswan Heart Centre, Magdi Yacoub Heart Foundation
- 2. • Know yourenemy • Previous wars • New targets Agenda
- 5. Anticoagulation in CADtrials 2001 2002 OASIS-main WARIS-2 2003ESTEEM RE-DEEM APPRAISE2 ATLAS-ACS2 GEMINI-ACS1 2011 2012 2017 ATACS1994 (Warfarin+ASA) ACS (NOAC+DAPT) ACS (NOAC+P2y12i) ACS (NOAC+ASA) CCS COMPASS2017 2018COMMANDER-HF (NOAC+) HF+CCS
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- 8. Warfarin + Aspirinafter ACS Old data (Before PPCI era)
- 10. The first usedNOAC (ximelagatran) + ASA post ACS Significant reduction in the composite of (death, myocardial infarction, CVS) at 6 months withdrawn due to liver toxicity. ESTEEM trial
- 11. RE-DEEM trial (1861patients) RCT (1:1) Dabigatran (50mg vs. 75mg vs. 110 mg vs. 150 mg) (b.i.d) vs. Placebo with DAPT after ACS Dose-related x 2-4 folds increased risk of bleeding (Major+clinically relevant minor) (ISTH)
- 12. APPRAISE-2 trial (7400patients) RCT (1:1) Apixaban 5mg (b.i.d) with Antiplatelet Therapy after ACS vs. Placebo Apixaban group had a higher rate of TIMI major bleedingNo significant reduction in recurrent ischemic events
- 13. ATLAS ACS (Phase2 trial) (Anti-Xa Therapy to Lower Cardiovascular Events in Addition to Standard Therapy in Subjects with ACS) • Enrolled 3491 ACS patients • Rivaroxaban total daily doses (5 to 20 mg) Vs. placebo • Reduced the composite end point of (death, MI, stroke) • Dose-dependent increase in bleeding events • Lowest hazard ratio (2.5 mg b.i.d)
- 14. ATLAS ACS 2(Phase 3 trial) (Anti-Xa Therapy to Lower Cardiovascular Events in Addition to Standard Therapy in Subjects with ACS) Rivaroxaban 2.5mg B.I.D Rivaroxaban 5mg B.I.D Placebo 1 2 3 RCT (1:1:1) • 15,526 patients • 766 Centers • 44 countries
- 15. ATLAS ACS 2(Phase 3 trial) (Anti-Xa Therapy to Lower Cardiovascular Events in Addition to Standard Therapy in Subjects with ACS) Rivaroxaban 2.5mg B.I.D Rivaroxaban 5mg B.I.D Placebo 1 2 3 > Inclusion criteria • Recent ACS (1 week) • If age < 55 , + (DM or old MI) > Exclusion criteria • Platelet < 90,000/ml • Hemoglobin < 10 g/dl • Significant GIT bleeding 12 months • Intracranial hemorrhage • Creatinine clearance <30 ml/min. • CVS or TIA while on DAPT
- 16. (Risk profile) • Meanage 62 years • Male (75%) • 26% (Old MI) • 32% (DM) • 67% (HTN) Presentation • 50% STEMI • 25% NSTEMI • 25% Unstable angina Treatment strategy • 60% (PCI/ CABG) • 93% on DAPT
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- 18. One major bleeding/ 67 patients treated with Rivaroxaban for 2 years 2.4%1.8% 0.6% 0.6% P 0.009 P 0.66
- 19. Rivaroxaban 2.5mg B.I.D Aspirin100 mg 1 GEMINI-ACS 1 (Phase2) (Low-dose Rivaroxaban vs. aspirin) + P2Y12 inhibition in ACS at 1 Year Multi-centre international double blinded RCT Ticagrelol Or Clopidogrel RCT (1:1) • 3037 ACS • 321 Centers • 21 countries
- 20. Rivaroxaban 2.5mg B.I.D Aspirin100 mg 1 GEMINI-ACS 1 (Phase2) (Low-dose Rivaroxaban vs. aspirin) + P2Y12 inhibition in ACS at 1 Year Multi-centre international double blinded RCT Ticagrelol Or Clopidogrel > Inclusion criteria • Recent ACS (1 week) • If age < 55 , + (DM or old MI) > Exclusion criteria • Active bleeding • Significant GIT bleeding 12 months • Intracranial hemorrhage • Creatinine clearance <20 ml/min. • Indication for full NOAC dose
- 21. (Risk profile) • Meanage 63 years • Male (75%) • 23% (Old MI) • 30% (DM) • 75% (HTN) Presentation • 49% STEMI • 40% NSTEMI • 11% Unstable angina Treatment strategy • 87% (PCI) • 56% on Ticagrelol
- 22. 5% 5% No significantdifference in bleeding or MACE (Not powered for MACE) Multivariable analysis > Higher bleeding with Ticagrelol (7% vs. 3%) N.B: Rivaroxaban arm > non-significantly higher ischemic events at 30 days
- 23. COMPASS (Cardiovascular Outcomes forPeople Using Anticoagulation Strategies) Multi-centre international double blinded RCT 2 RCT (1:1:1) • 27395 patients • 602 Centers • 33 countries
- 24. COMPASS (Cardiovascular Outcomes forPeople Using Anticoagulation Strategies) Multi-centre international double blinded RCT 2 > Inclusion criteria • CAD or PAD • If age < 65 : + 2 RF (DM, smoker, GFR <60), HF, CVS> 1 month) or Documented atherosclerosis in 2 vascular beds > Exclusion criteria • High bleeding risk • Intracranial hemorrhage • Creatinine clearance <15 ml/min. • Advanced HF • On DAPT therapy • Indicated for full dose NOAC • Other condition with poor prognosis
- 25. (Risk profile) • Meanage 68 years • Male (78%) • 62% (Old MI) • 38% (DM) • 75% (HTN) • 21% (HF) Presentation • 91% CAD • 27% PAD PPI • 36% already on PPI • Other randomized (1:1) for PPI
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- 27. P value forsignificance = 0.0025
- 29. + any bleedingthat led to hospitalization with or without an overnight stay Leads to 30 % increase in the bleeding endpoint
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- 33. COMMANDER HF trial(5022 patients) RCT (1:1) Rivaroxaban 2.5mg (b.i.d) vs. Placebo HFrEF+ CCS Rivaroxaban group had a higher ISTH major bleeding No significant reduction in MACE • 93% on ASA • 35% on DAPT
- 35. High ischemic risk Diffusemulti-vessel CAD plus one of the following: -DM -Recurrent MI -PAD -CKD eGFR (15-59) Intermediate ischemic risk -Any of the above -Heart failure High bleeding risk -Prior intracerebral hge or stroke -Recent GIT bleeding or Anemia -Intracerebral or GIT pathology -Liver failure -Coagulopathy -Frailty -eGFR < 15 or dialysis
- 36. Adding to DAPTfrom the start (ATLAS-ACS)
- 37. Adding to ASAafter 12 months of DAPT (COMPASS)
- 40. Take home message •Low dose Rivaroxaban plus DAPT post ACS reduced MACE, yet with increased bleeding risk (ATLAS-ACS 2) • Low dose Rivaroxaban plus ASA in CCS reduced MACE, again with increased bleeding risk (COMPASS) • Tailored patient approach should be adopted
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