Kosiuk Jedrzej, Koutalas Emmanuel, Doering Michael, Sommer Philipp, Rolf Sascha, Breithardt Ole-A, Nedios Sotirios, Dinov Borislav, Hindricks Gerhard, Richter Sergio, Bollmann Andreas
Department of Electrophysiology, Heart Center, Leipzig, Strümpellstrasse 39, 04289 Leipzig, Germany
Department of Electrophysiology, Heart Center, Leipzig, Strümpellstrasse 39, 04289 Leipzig, Germany.
Europace. 2014 Jul;16(7):1028-32. doi: 10.1093/europace/eut423. Epub 2014 Jan 31.
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.
新型口服抗凝药在接受起搏器或植入式心脏复律除颤器干预的房颤患者中的安全性和有效性尚未明确界定。因此，我们在一个真实世界队列中比较了在植入心脏节律装置（CRD）时使用达比加群与利伐沙班后出血和血栓栓塞并发症的发生率。
我们分析了分别在围手术期接受达比加群治疗的93例患者和接受利伐沙班治疗的83例患者连续进行的176例手术。比较了术后30天内发生的出血并发症和血栓栓塞事件。达比加群组和利伐沙班组患者的基线特征无显著差异。两组中的大多数患者接受双腔或心脏再同步化装置（分别为71%和78%），而非单腔系统（分别为29%和22%）。在达比加群组中，观察到2例（2%）出血并发症（2例囊袋血肿），而利伐沙班组为4例（5%，3例囊袋血肿和1例心包积液）（P = 0.330）。利伐沙班组有3例并发症需要手术干预，而达比加群组无（P = 0.064）。达比加群组发生1例短暂性脑缺血发作（P = 0.343）。
接受达比加群或利伐沙班治疗的患者中出血和血栓栓塞并发症很少见。需要进一步开展更大规模的研究来确定需要口服抗凝治疗且接受CRD干预的患者的最佳抗凝管理方案。
