Bleeding in patients with atrial fibrillation treated with dabigatran, rivaroxaban or warfarin: A retrospective population-based cohort study.
BACKGROUND
Randomized controlled trials (RCTs) have shown that dabigatran, rivaroxaban and warfarin cause similar bleeding rates.


METHODS
We performed a retrospective population-based cohort study to determine the incidence of bleeding in patients with atrial fibrillation (AF) beginning dabigatran, rivaroxaban or warfarin. Consecutive patients initiating anticoagulation for AF during a 3year period were identified using a computerized database. Patients who bled and required hospitalization underwent chart review. Bleeding incidences were calculated per 100 patient-years of treatment.


RESULTS
18,249 patients were included: 9564 (52.4%) received warfarin, 5976 (32.7%) dabigatran, and 2709 (14.8%) rivaroxaban. Bleeding incidences were 3.9 (95% CI, 3.6-4.4) in warfarin-treated patients, 4.2 (95% CI, 3.7-4.7) in dabigatran patients, and 4.1 (95% CI, 3.0-5.3) in rivaroxaban patients. Intracranial hemorrhage (ICH) rates were 0.71 (95% CI, 0.56-0.90) for warfarin, 0.4 (95% CI, 0.18-0.87) for dabigatran, and 0.27 (95%CI, 0.10-0.80) for rivaroxaban. GI hemorrhage rates were 1.88 (95%CI, 1.62-2.20) for warfarin, 2.98 (95% CI, 2.4-3.5) for dabigatran and 2.39 (95%CI, 1.6-3.5) for rivaroxaban.


CONCLUSIONS
We demonstrate similar bleeding rates with both dabigatran 150mg and 110mg and rivaroxaban compared to warfarin.
Hematology Institute and Blood Bank, Meir Medical Center, 59 Tchernichovsky St, Kfar Saba 44281 ISRAEL; Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel. Electronic address: martinel@clalit.org.il.
Martin H
MH
Ellis
Department of Medicine D, Meir Medical Center, 59 Tchernichovsky St Kfar Saba 44281, ISRAEL.
Tsipora
T
Neuman
Chief Physician's Office Clalit Health Services, 101 Arlozorov St 62098 Tel Aviv ISRAEL.
Haim
H
Bitterman
Chief Physician's Office Clalit Health Services, 101 Arlozorov St 62098 Tel Aviv ISRAEL.
Sari Greenberg
SG
Dotan
Chief Physician's Office Clalit Health Services, 101 Arlozorov St 62098 Tel Aviv ISRAEL.
Ariel
A
Hammerman
Chief Physician's Office Clalit Health Services, 101 Arlozorov St 62098 Tel Aviv ISRAEL.
Erez
E
Battat
McMaster University, Hamilton, Ontario.
John W
JW
Eikelboom
McMaster University, Hamilton, Ontario.
Jeffrey S
JS
Ginsberg
McMaster University, Hamilton, Ontario.
Jack
J
Hirsh
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000008:administration & dosage / Q000009:adverse effects*; D001281:Atrial Fibrillation / Q000188:drug therapy*; D000069604:Dabigatran / Q000008:administration & dosage / Q000009:adverse effects*; D016208:Databases, Factual; D005260:Female; D006471:Gastrointestinal Hemorrhage / Q000139:chemically induced / Q000401:mortality*; D006801:Humans; D015994:Incidence; D020300:Intracranial Hemorrhages / Q000139:chemically induced / Q000401:mortality*; D007557:Israel; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D012189:Retrospective Studies; D000069552:Rivaroxaban / Q000008:administration & dosage / Q000009:adverse effects*; D020521:Stroke / Q000517:prevention & control; D014859:Warfarin / Q000008:administration & dosage / Q000009:adverse effects*
D000925:Anticoagulants; D014859:Warfarin; D000069552:Rivaroxaban; D000069604:Dabigatran
Bleeding risk; DOACs; Real-world