Comparing Safety and Efficacy of Rivaroxaban with Warfarin for Patients after Successful Stent Placement for Chronic Iliofemoral Occlusion: A Retrospective Single Institution Study
Comparing Safety and Efficacy of Rivaroxaban with Warfarin for Patients after Successful Stent Placement for Chronic Iliofemoral Occlusion: A Retrospective Single Institution Study
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比较利伐沙班与华法林对慢性髂股闭塞支架置入成功后患者的安全性和有效性：一项回顾性单机构研究
DOI：
10.1016/j.ejvs.2020.11.050
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发表时间：
2021-03-11
影响因子：
5.7
通讯作者：
Ye, Kaichuang
中科院分区：
文献类型：
--
作者：
Zhang, Xing;Huang, Jiaqi;Ye, Kaichuang
目的：目的是比较利伐沙班和华法林抗凝治疗慢性髂股静脉闭塞血栓后综合征（PTS）患者行髂股静脉stenting.Methods的安全性和有效性：这一单机构回顾性研究分析了PTS患者慢性髂股静脉闭塞谁规定利伐沙班或华法林一年后成功地接受髂股静脉支架植入术。主要安全性和有效性终点为1年时出血并发症发生率和一期通畅率。次要结局包括Villalta评分、症状复发率、溃疡愈合率和随访期间临床驱动的靶病变血运重建（CD-TLR）率。结果：从2016年1月至2017年12月，本研究纳入了154例患者的154条腿（利伐沙班组69条，华法林组85条）。两组在患者人口统计学、临床特征和手术细节方面匹配良好。利伐沙班组与华法林组的出血并发症发生率无显著差异（10% vs. 16%，p = 0.23，风险比[HR] 0.58，95%置信区间[CI] 0.25 - 1.37）以及大出血并发症发生率（0% vs. 2%，p = 0.20，HR 0.16，95% CI 0.01 - 2.61）和轻微出血并发症发生率（10% vs. 14%，p = 0.40，HR 0.67，95% CI 0.27 - 1.66）。利伐沙班组1年（84% vs. 71%，p = 0.049，HR 0.50，95% CI 0.26 - 0.96）和2年（79% vs. 63%，p = 0.037，HR 0.52，95% CI 0.29 - 0.93）时的一期通畅率较高。平均随访24个月（范围1 - 42个月），利伐沙班组的术后Villalta评分显著较低（4.87 +/- 3.51 vs. 6.88 +/- 5.85，p = 0.010，t = 2.64，95% CI 0.50 - 3.52），症状复发率较低（4% vs. 32%，p < .001），CD-TLR率较低（3% vs. 13%，p = 0.039），溃疡愈合率更高（90%对59%，p = .004）。结论：对于接受髂股静脉支架植入术的慢性髂股静脉闭塞PTS患者，利伐沙班可能表现出与华法林相似的安全性但上级功效。然而，需要进一步的大样本前瞻性对照研究来证实结果。
Objective: The aim was to compare the safety and effectiveness of rivaroxaban and warfarin as anticoagulants for treating patients with post-thrombotic syndrome (PTS) with chronic iliofemoral venous occlusion undergoing iliofemoral venous stenting.Methods: This single institution retrospective study analysed patients with PTS with chronic iliofemoral venous occlusion who were prescribed rivaroxaban or warfarin for one year after successfully undergoing iliofemoral venous stenting. The primary safety and efficacy endpoints were bleeding complication rate and primary patency rate at one year. Secondary outcomes included Villalta score, symptom recurrence rate, ulcer healing rate, and clinically driven target lesion revascularisation (CD-TLR) rate during follow up.Results: From January 2016 to December 2017, 154 legs from 154 patients were included in this study (69 in rivaroxaban group and 85 in warfarin group). The groups were well matched for patient demographics, clinical characteristics, and procedural details. There was no significant difference between the rivaroxaban group and warfarin group in bleeding complication rate (10% vs. 16%, p = .23, hazard ratio [HR] 0.58, 95% confidence interval [CI] 0.25 - 1.37) at one year, as well as major bleeding complication rate (0% vs. 2%, p = .20, HR 0.16, 95% CI 0.01 - 2.61) and minor bleeding complication rate (10% vs. 14%, p = .40, HR 0.67, 95% CI 0.27 - 1.66). The primary patency rate was higher in the rivaroxaban group at one year (84% vs. 71%, p = .049, HR 0.50, 95% CI 0.26 - 0.96) and at two years (79% vs. 63%, p = .037, HR 0.52, 95% CI 0.29 - 0.93). At a mean follow up of 24 months (range 1 - 42 months), the rivaroxaban group had a significantly lower postoperative Villalta score (4.87 +/- 3.51 vs. 6.88 +/- 5.85, p = .010, t = 2.64, 95% CI 0.50 - 3.52), lower rate of symptom recurrence (4% vs. 32%, p < .001), lower CD-TLR rates (3% vs. 13%, p = .039), and higher ulcer healing rate (90% vs. 59%, p = .004) than the warfarin group.Conclusion: For PTS patients with chronic iliofemoral venous occlusion undergoing iliofemoral venous stenting, rivaroxaban probably exhibited similar safety but superior efficacy to warfarin. However, further prospective control studies with large sample size are necessary to confirm the results.