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
Actualización de los nuevos anticoagulantes orales en base a datos en práctica clínica real
1. Actualización de los nuevos anticoagulantes orales
en base a datos en práctica clínica real
Madrid, septiembre 2016
Domingo Marzal Martín
ANTICOAGULACIÓN 3.0
5. stroke or SEE secondary 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
20. Tepper P; et al. 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; et al. 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 60 90 120 150 180
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, et al. 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, et al. 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, et al. 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
28. Lip G, et al. 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