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Actualización de los nuevos anticoagulantes orales en base a datos en práctica clínica real
This document summarizes data from clinical studies and real-world evidence on the new oral anticoagulants for atrial fibrillation. It finds that dabigatran 150mg twice daily reduces ischemic stroke and mortality compared to warfarin based on a study of 56,576 Medicare patients, but increases gastrointestinal bleeding in those over 75 years old. Real-world data also finds apixaban reduces major bleeding, hospitalizations and inpatient bleeding compared to dabigatran and rivaroxaban. Studies of patients over 75 years old initiating anticoagulants find warfarin, rivaroxaban and dabigatran have higher risks of major bleeding than apixaban. The document
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Actualización de los nuevos anticoagulantes orales en base a datos en práctica clínica real
- 1. Actualización de losnuevos anticoagulantes orales en base a datos en práctica clínica real Madrid, septiembre 2016 Domingo Marzal Martín ANTICOAGULACIÓN 3.0
- 2. AVK …“nuevo ACO” datosde vida real
- 3. Bleeding Thrombosis Björck F, etal. JAMA Cardiol. 2016;1:172-80
- 4. Bleeding CNS Bleeding Björck F,et al. JAMA Cardiol. 2016;1:172-80
- 5. stroke or SEEsecondary efficacy outcomes major bleedings secondary safety outcomes Ruff CT, et al. Lancet 2014;383:955-62 Efficacy and safety of NOACs vs warfarin in atrial fibrillation: a meta-analysis of randomised trials
- 6.
- 7. Connolly et al.N Engl J Med. 2009;361:1139-51 Graham DJ et al. Circulation. 2015;131:157-64 Independent FDA study of Medicare patients
- 8. Resultados dabigatran 150mg BID n=56.576 Medicare analysis1 HR (95% CI) Ictus isquémico 0.70 (0.57–0.85) Mortalidad 0.76 (0.67–0.86) Hemorragia grave GI 1.51 (1.32–1.73) HIC 0.30 (0.21–0.42) Favor warfarina 0.1 2.01.0 Favor dabigatran Dabigatran vs warfarina Hemorragia grave GI superior en: •Mujeres ≥ 75 años •Hombres ≥ 85 años Graham DJ et al. Circulation. 2015;131:157-64
- 9. Connolly et al.N Engl J Med. 2009;361:1139-51 Villines TC, et al. Thromb Haemost. 2015;14:1290-8 Department of Defense
- 10. Larsen TB etal. Am J Med. 2014;127:650-6 National Danish Registries bleeding risk n=11.315 0.10 0.50 1.00 2.00 5.00 0.72 (0.59–0.88) 0.93 (0.74–1.16) 0.52 (0.28–0.95) 0.50 (0.27–0.94) 0.30 (0.17–0.54) Favours dabigatran Favours warfarin VKA-naïve stratum 0.68 (0.55–0.84) 0.67 (0.53–0.85) 0.70 (0.33–1.52) 1.45 (0.84–2.50) 0.33 (0.17–0.66) Any Major Fatal GI ICH Any Major Fatal GI ICH Dabigatran 110 mg vs warfarin Dabigatran 150 mg vs warfarin HR (95% CI)
- 11.
- 12. Patel MR, etal. N Engl J Med. 2011;365:883-91 Tamayo S, et al. Clin Cardiol. 2015;38:63-8 0 1 2 3 4 Hemorragias mayores 3,6% 2.9% ROCKET AF Farmacovigilancia Eventos(%/año) n=7.111 rivaroxaban n=27.476 US Pharmacovigilance Study
- 13. US Pharmacovigilance Study 0 0,2 0,4 0,6 Hemorragia intracraneal Hemorragiamortal 0,5% 0,2%0,2% <0,1% ROCKET AF Farmacovigilancia Eventos(%/año) Patel MR, et al. N Engl J Med. 2011;365:883-91 Tamayo S, et al. Clin Cardiol. 2015;38:63-8
- 14. CHADS2 Ictus previoa ROCKETAF 3,5 55 % XANTUS 2,0 19 % 0 0,5 1 1,5 2 Ictus/ES Todos tipos ictus Muerte 1,7 1,7 1,9 0,8 0,7 1,9 ROCKET AF XANTUS Tasadeincidencia,%/año Camm AJ, et al, Eur Heart J. 2016;37:1145-53
- 15. CHADS2 Ictus previoa ROCKETAF 3,5 55 % XANTUS 2,0 19 % 0 0,5 1 1,5 2 2,5 3 3,5 4 Hemorragia mayor HIC Hemorragia digestiva 3,6 0,5 2,02,1 0,4 0,9 ROCKET AF XANTUS Tasadeincidencia,%/año Camm AJ, et al, Eur Heart J. 2016;37:1145-53
- 16.
- 17. baseline characteristics Deitelzweig S,et al. ESC Congress 2015; oral poster no.1971
- 18. Deitelzweig S, etal. ESC Congress 2015; oral poster no.1971 major bleeding all-cause hospitalization
- 19. ***P<.001; **P<.01; *P<.05 TepperP; et al. ESC Congress 2015; oral poster no.1975
- 20. Tepper P; etal. ESC Congress 2015; oral poster no.1975 Dabigatran vs apixaban 0 0,5 1 1,5 2 0 0,5 1 1,5 2 2,5 Hemorragia grave HIC Hemorragia GI grave Hemorragia NGCR Hemorragia GI NGCR CRI CRI Favorece a dabigatrán Favorece a apixaban Favorece a rivaroxaban Favorece a apixaban CRI 1.34 (1.20-1.51)CRI 0.99 (0.86-1.12) CRI 1.41 (1.01-1.97)CRI 1.08 (0.75-1.55) CRI 1.54 (1.23-1.91)CRI 1.04 (0.83-1.32) CRI 1.39 (1.28-1.51)CRI 1.03 (0.95-1.12) CRI 1.50 (1.31-1.73)CRI 1.24 (1.07-1.44) Rivaroxaban vs apixaban
- 21. Tepper P; etal. ESC Congress 2015; oral poster no.1975 adjusted incidences of bleeding inpatient bleeding
- 22. 0% 2% 4% 6% 8% 10% 12% 14% 16% 18% 20% 0 30 6090 120 150 180 CumulativeProportionofPatients withAnyBleed Days following Index Apixaban Dabigatran Warfarin Rivaroxaban Log rank P < 0.0001 Lin I, et al. ESC Congress 2015; oral poster no.P6215 Real-world Bleeding Risk among NVAF Patients Prescribed Apixaban, Dabigatran, Rivaroxaban, and Warfarin: Analysis of Electronic Health Records analysis of any bleed during follow up Warfarina vs apixaban: HR 1.34 (95% Cl 1.13–1.58) Rivaroxaban vs apixaban: HR 1.46 (95% Cl 1.23–1.75) Dabigatrán vs apixaban: HR 0.91 (95% Cl 0.73–1.13)
- 23. Lip G, etal. ESC Congress 2015; oral poster no.P6217 Real World Comparison of Major Bleeding Risk Among NVAF Patients Newly Initiated on Apixaban, Dabigatran, Rivaroxaban or Warfarin Dabigatran (4.173) 150 mg NR 3.768 405 Rivaroxaban (10.050) 20 mg NR 8.066 1.984 Apixaban (2.402) 5 mg NR 2.057 345 Warfarin (12.713) cumulative incidence of major bleeding %patientsmajorbleeding (Inpatientbleeding) Time from Anticoagulation initiation (days) 0 0 1 2 3 4 5 30 60 90 120 150 180 210 240 270 300 330 360 390 Warfarin vs Apixaban: HR 1.93 (95% CI 1.12–3.33) P=0.018 Rivaroxaban vs Apixaban: HR 2.19 (95% Cl 1.26 –3.79) P=0.0052 Dabigatran vs Apixaban: HR 1.71 (95% Cl 0.94–3.10) P= 0.079
- 24. Lip G, etal. ESC Congress 2016 Poster Presentation Is Major Bleeding Risk for Oral Anticoagulants Similar Between Non-Valvular Atrial Fibrillation Patients Newly Initiated On Warfarin and Propensity Score Matched NOAC Initiators? A Real- World Study
- 25. Lip G, etal. ESC Congress 2016 Poster Presentation Is Major Bleeding Risk for Oral Anticoagulants Similar Between Non-Valvular Atrial Fibrillation Patients Newly Initiated On Warfarin and Propensity Score Matched NOAC Initiators? A Real- World Study
- 26. Larsen TB etal. BMJ 2016;353:i3189
- 27. Masseria LI, etal. ESC Congress 2016 Presentation
- 28. Lip G, etal. ESC Congress 2016 Poster Presentation Major Bleeding Risk in Patients ≥75 Years with NVAF Initiating Oral Anticoagulants: A Real-world Comparison of Warfarin, Apixaban, Dabigatran, or Rivaroxaban
- 30.
- 32. Adapted from Laneet al. Presented at ESOC 2016 (ESOC6-0603)
- 35. gracias por vuestraatención domingo.marzal@secardiologia.es @domingomarzal