Department of Medicine, Stanford Center for Clinical Research, Stanford University School of Medicine, Stanford, CA.
Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.
J Am Heart Assoc. 2017 Jun 14;6(6):e004663. doi: 10.1161/JAHA.116.004663.
Although implantation of cardiac implantable electronic devices (CIEDs) in patients receiving warfarin is well studied, limited data are available on the use of oral factor Xa inhibitors in this setting.
Using data from Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) (n=14 264), we compared baseline characteristics and clinical outcomes in patients with atrial fibrillation randomized to rivaroxaban versus warfarin who did and did not undergo CIED implantation or revision. In this post-hoc, postrandomization, on-treatment analysis, only the first intervention per patient was analyzed. During a median follow-up of 2.2 years, 453 patients (242 rivaroxaban group; 211 warfarin group) underwent de novo CIED implantation (64.2%) or revision procedures (35.8%). Patients who received CIEDs were older, more likely to be male, and more likely to have past myocardial infarction, but had similar stroke risk compared to patients who did not receive CIEDs. Most patients who received a device had study drug interrupted for the procedure and did not receive bridging anticoagulation. During the 30-day postprocedural period, 11 patients (4.55%) in the rivaroxaban group experienced bleeding complications compared with 15 (7.13%) in the warfarin group. Thromboembolic complications occurred in 3 patients (1.26%) in the rivaroxaban group and 1 (0.48%) in the warfarin group. Event rates were too low for formal hypothesis testing.
Bleeding and thromboembolic events were low in both rivaroxaban- and warfarin-treated patients. Periprocedural use of oral factor Xa inhibitors in CIED implantation requires further study in prospective, randomized trials.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00403767.
尽管在接受华法林治疗的患者中植入心脏植入式电子设备（CIED）已有充分研究，但在这种情况下使用口服 Xa 因子抑制剂的数据有限。
利用从每日口服单次利伐沙班与维生素 K 拮抗剂预防非瓣膜性心房颤动血栓栓塞事件的（ROCKET AF）研究（n=14264）的数据，我们比较了随机分至利伐沙班组和华法林组的伴有房颤且接受或未接受 CIED 植入或修正术的患者的基线特征和临床结局。在这一事后、随机化后、治疗期分析中，仅对每位患者的首次干预进行了分析。在中位随访 2.2 年期间，453 例患者（利伐沙班组 242 例，华法林组 211 例）接受了新的 CIED 植入（64.2%）或修正术（35.8%）。接受 CIED 的患者年龄更大，更可能为男性，且更可能有既往心肌梗死，但与未接受 CIED 的患者相比，其卒中风险相似。大多数接受设备的患者为手术中断研究药物治疗且未接受桥接抗凝治疗。在术后 30 天期间，利伐沙班组有 11 例（4.55%）患者发生出血并发症，而华法林组有 15 例（7.13%）。利伐沙班组有 3 例（1.26%）患者发生血栓栓塞并发症，华法林组有 1 例（0.48%）。由于事件发生率太低，无法进行正式的假设检验。
利伐沙班和华法林治疗的患者出血和血栓栓塞事件发生率均较低。在 CIED 植入术围手术期使用口服 Xa 因子抑制剂需要进一步在前瞻性、随机试验中研究。
