Treatment with novel oral anticoagulants in a real-world cohort of patients undergoing cardiac rhythm device implantations.
OBJECTIVE
The safety and efficacy of novel oral anticoagulants in patients with atrial fibrillation undergoing pacemaker or implantable cardioverter-defibrillator interventions have not been clearly defined. Therefore, we compared the incidence of bleeding and thrombo-embolic complications following cardiac rhythm device (CRD) implantations under dabigatran vs. rivaroxaban in a real-world cohort.


RESULTS
We analysed 176 consecutive procedures performed in 93 patients treated peri-interventionally with dabigatran and 83 patients with rivaroxaban, respectively. Post-operative bleeding complications and thrombo-embolic events occurring within 30 days were compared. There were no significant differences in baseline characteristics between patients in the dabigatran and the rivaroxaban group. Most of the patients in both the groups received dual chamber or cardiac resynchronization devices (71 vs. 78%) as opposed to single-chamber systems (29 vs. 22%). In the dabigatran group, two (2%) bleeding complications (two pocket haematomas) were observed in comparison with four (5%, three pocket haematomas and one pericardial effusion) in the rivaroxaban group (P = 0.330). Three complications in the rivaroxaban group necessitated surgical intervention as opposed to none in the dabigatran group (P = 0.064). One case of a transient ischaemic attack occurred in the dabigatran group (P = 0.343).


CONCLUSIONS
Bleeding and thrombo-embolic complications in patients treated with dabigatran or rivaroxban are rare. Further and larger studies are warranted to define the optimal anticoagulation management in patients with a need for oral anticoagulation and CRD interventions.
Department of Electrophysiology, Heart Center, Leipzig, Strümpellstrasse 39, 04289 Leipzig, Germany jedrzejkosiuk@hotmail.com.
Jedrzej
J
Kosiuk
Department of Electrophysiology, Heart Center, Leipzig, Strümpellstrasse 39, 04289 Leipzig, Germany.
Emmanuel
E
Koutalas
Department of Electrophysiology, Heart Center, Leipzig, Strümpellstrasse 39, 04289 Leipzig, Germany.
Michael
M
Doering
Department of Electrophysiology, Heart Center, Leipzig, Strümpellstrasse 39, 04289 Leipzig, Germany.
Philipp
P
Sommer
Department of Electrophysiology, Heart Center, Leipzig, Strümpellstrasse 39, 04289 Leipzig, Germany.
Sascha
S
Rolf
Department of Electrophysiology, Heart Center, Leipzig, Strümpellstrasse 39, 04289 Leipzig, Germany.
Ole-A
OA
Breithardt
Department of Electrophysiology, Heart Center, Leipzig, Strümpellstrasse 39, 04289 Leipzig, Germany.
Sotirios
S
Nedios
Department of Electrophysiology, Heart Center, Leipzig, Strümpellstrasse 39, 04289 Leipzig, Germany.
Borislav
B
Dinov
Department of Electrophysiology, Heart Center, Leipzig, Strümpellstrasse 39, 04289 Leipzig, Germany.
Gerhard
G
Hindricks
Department of Electrophysiology, Heart Center, Leipzig, Strümpellstrasse 39, 04289 Leipzig, Germany.
Sergio
S
Richter
Department of Electrophysiology, Heart Center, Leipzig, Strümpellstrasse 39, 04289 Leipzig, Germany.
Andreas
A
Bollmann
D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000008:administration & dosage*; D001281:Atrial Fibrillation / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D001562:Benzimidazoles / Q000008:administration & dosage* / Q000009:adverse effects; D002304:Cardiac Pacing, Artificial / Q000009:adverse effects; D000069604:Dabigatran; D017147:Defibrillators, Implantable; D004554:Electric Countershock / Q000009:adverse effects / Q000295:instrumentation*; D005260:Female; D005858:Germany / Q000453:epidemiology; D006406:Hematoma / Q000139:chemically induced / Q000453:epidemiology; D006470:Hemorrhage / Q000139:chemically induced / Q000453:epidemiology; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000008:administration & dosage* / Q000009:adverse effects; D010138:Pacemaker, Artificial; D011446:Prospective Studies; D011474:Prosthesis Design; D019919:Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation*; D012307:Risk Factors; D000069552:Rivaroxaban; D013876:Thiophenes / Q000008:administration & dosage* / Q000009:adverse effects; D013923:Thromboembolism / Q000175:diagnosis / Q000453:epidemiology / Q000517:prevention & control*; D013997:Time Factors; D016896:Treatment Outcome; D015091:beta-Alanine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*
D000925:Anticoagulants; D001562:Benzimidazoles; D009025:Morpholines; D013876:Thiophenes; D015091:beta-Alanine; D000069552:Rivaroxaban; D000069604:Dabigatran
Dabigatran; Implantable cardioverter-defibrillator; Pacemaker; Rivaroxaban