Comparison of the Efficacy and Safety of Direct Oral Anticoagulants and Warfarin After Bioprosthetic Valve Replacements
Comparison of the Efficacy and Safety of Direct Oral Anticoagulants and Warfarin After Bioprosthetic Valve Replacements
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DOI：
10.1007/s40261-020-00939-x
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发表时间：
2020-06-30
影响因子：
3.2
通讯作者：
Wright, Kesha
中科院分区：
文献类型：
--
作者：
Pasciolla, Stacy;Zizza, Laura Falconieri;Wright, Kesha
背景和目的目前的指南建议在生物瓣膜置换术后使用维生素K拮抗剂（华法林）进行抗凝治疗。在刚刚接受生物主动脉瓣置换术（AVR）或二尖瓣置换术（MVR）的患者中评价直接口服抗凝剂（DOAC）的文献极少。本研究的目的是研究生物瓣膜AVR或MVR后服用DOAC的患者与华法林相比的有效性和安全性差异。方法对2014年至2018年在一家大型教学医院接受生物瓣膜置换术的患者进行回顾性队列研究，以评估抗凝治疗。本研究纳入的患者在生物瓣膜AVR或MVR后接受华法林或DOAC，并在整个6个月随访期间维持相同药物。主要疗效结局为血栓栓塞并发症的发生率，主要安全性结局为术后6个月内大出血的发生率。再入院率作为次要终点进行评估。结果共纳入197例患者; 70例患者接受华法林治疗，127例患者接受DOAC治疗（阿哌沙班，n = 86;利伐沙班，n = 40;达比加群，n = 1）。3例患者发生血栓栓塞事件，均发生在DOAC组（0% vs. 2.4%;p = 0.20）。11例患者发生大出血-华法林组2例，DOAC组9例（2.9% vs. 7.1%;p = 0.22）。61例患者在6个月时间范围内再次入院，华法林组26例再次入院，DOAC组35例再次入院（37% vs. 27%;p = 0.16）。结论：这项小型探索性研究发现，在近期生物瓣膜AVR或MVR后接受DOAC与华法林的患者中，血栓栓塞并发症和大出血事件的发生率相似。本研究受其回顾性和样本量的限制。需要更大规模的随机对照试验来进一步确定DOAC在该患者人群中的疗效和安全性。
Background and Objective Current guidelines recommend anticoagulation with a vitamin K antagonist (warfarin) after a bioprosthetic valve replacement. There is minimal literature evaluating direct oral anticoagulants (DOACs) in patients who have just received a bioprosthetic aortic valve replacement (AVR) or mitral valve replacement (MVR). The purpose of this study was to investigate any differences in efficacy and safety for patients taking a DOAC, compared with warfarin, after a bioprosthetic AVR or MVR. Methods A retrospective cohort study was performed to evaluate anticoagulation in patients who received bioprosthetic valve replacements at a large teaching hospital from 2014 to 2018. Patients included in this study received either warfarin or a DOAC following bioprosthetic AVR or MVR, and were maintained on the same agent throughout the 6-month follow-up period. The primary efficacy outcome was the incidence of thromboembolic complications and the primary safety outcome was the incidence of major bleeding within 6 months following surgery. The rate of readmission was assessed as a secondary endpoint. Results A total of 197 patients were included; 70 patients received warfarin and 127 patients received a DOAC (apixaban,n = 86; rivaroxaban,n = 40; dabigatran,n = 1). Three patients experienced thromboembolic events, all of which occurred in the DOAC group (0% vs. 2.4%;p = 0.20). Major bleeding occurred in 11 patients-two in the warfarin group and nine in the DOAC group (2.9% vs. 7.1%;p = 0.22). Sixty-one patients were readmitted within the 6-month time frame, with 26 readmissions in the warfarin group and 35 readmissions in the DOAC group (37% vs. 27%;p = 0.16). Conclusions This small, exploratory study found similar rates of thromboembolic complications and major bleeding events in patients who received a DOAC versus warfarin after a recent bioprosthetic AVR or MVR. This study was limited by its retrospective nature and its sample size. Larger, randomized controlled trials are needed to further determine the efficacy and safety of DOACs in this patient population.