Treatment with novel oral anticoagulants in a real-world cohort of patients undergoing cardiac rhythm device implantations

• Published in: Europace (London, England) England), 2014-07, Vol.16 (7), p.1028-1032
• Main Authors: Kosiuk, Jedrzej, Koutalas, Emmanuel, Doering, Michael, Sommer, Philipp, Rolf, Sascha, Breithardt, Ole-A, Nedios, Sotirios, Dinov, Borislav, Hindricks, Gerhard, Richter, Sergio, Bollmann, Andreas
• Format: Article
• Language: English
• Subjects: Administration, Oral; Aged; Aged, 80 and over; Anticoagulants - administration & dosage; Atrial Fibrillation - diagnosis; Atrial Fibrillation - physiopathology; Atrial Fibrillation - therapy; Benzimidazoles - administration & dosage; Benzimidazoles - adverse effects; beta-Alanine - administration & dosage; beta-Alanine - adverse effects; beta-Alanine - analogs & derivatives; Cardiac Pacing, Artificial - adverse effects; Dabigatran; Defibrillators, Implantable; Electric Countershock - adverse effects; Electric Countershock - instrumentation; Female; Germany - epidemiology; Hematoma - chemically induced; Hematoma - epidemiology; Hemorrhage - chemically induced; Hemorrhage - epidemiology; Humans; Incidence; Male; Middle Aged; Morpholines - administration & dosage; Morpholines - adverse effects; Pacemaker, Artificial; Prospective Studies; Prosthesis Design; Prosthesis Implantation - adverse effects; Prosthesis Implantation - instrumentation; Risk Factors; Rivaroxaban; Thiophenes - administration & dosage; Thiophenes - adverse effects; Thromboembolism - diagnosis; Thromboembolism - epidemiology; Thromboembolism - prevention & control; Time Factors; Treatment Outcome
• ISSN: 1099-5129; 1532-2092
• DOI: 10.1093/europace/eut423

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. 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). 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.