Department of Pharmacy, ChristianaCare, Newark, DE, USA.
Philadelphia College of Pharmacy, University of the Sciences, Philadelphia, PA, USA.
Clin Drug Investig. 2020 Sep;40(9):839-845. doi: 10.1007/s40261-020-00939-x.
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.
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.
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).
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.
目前的指南建议在生物瓣置换后使用维生素 K 拮抗剂（华法林）进行抗凝治疗。很少有文献评估在刚刚接受生物瓣主动脉瓣置换术（AVR）或二尖瓣置换术（MVR）的患者中使用直接口服抗凝剂（DOAC）。本研究的目的是评估与华法林相比，在接受生物瓣置换术后使用 DOAC 的患者的疗效和安全性是否存在差异。
对 2014 年至 2018 年在一家大型教学医院接受生物瓣置换术的患者进行了回顾性队列研究。本研究纳入的患者在接受生物瓣 AVR 或 MVR 后接受华法林或 DOAC 治疗，并且在 6 个月的随访期间均使用相同的药物。主要疗效结局是血栓栓塞并发症的发生率，主要安全性结局是术后 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。
共纳入 197 例患者，70 例接受华法林治疗，127 例接受 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，其中 2 例发生在华法林组，9 例发生在 DOAC 组（2.9% vs. 7.1%；p=0.22）。61 例患者在 6 个月时间内再入院，华法林组有 26 例再入院，DOAC 组有 35 例再入院（37% vs. 27%；p=0.16）。
这项小型探索性研究发现，在近期接受生物瓣 AVR 或 MVR 的患者中，使用 DOAC 与华法林相比，血栓栓塞并发症和大出血事件的发生率相似。本研究受到回顾性研究和样本量的限制。需要更大规模的随机对照试验来进一步确定 DOAC 在这一患者群体中的疗效和安全性。
