利伐沙班在下肢深静脉血栓形成后综合征腔内治疗术后的疗效研究

Clinical efficacy of rivaroxaban in endovascular treatment for lower extremity post-thrombotic syndrome

目的对比分析髂静脉支架植入术后血栓形成后综合征(post-thrombotic syndrome,PTS)患者应用利伐沙班与华法林抗凝治疗的安全性与有效性。方法选择2017年1月至2020年12月中国人民解放军第九七〇医院血管外科收治的132例成功实施髂静脉支架植入术的PTS患者,术后给予抗凝治疗1年,随机分组为利伐沙班组59例,华法林组73例。主要安全性结局指标为1年内出血发生率,主要有效性结局指标为支架一期通畅率,次要结局指标包括Villalta评分、症状复发率和溃疡愈合率。结果两组患者基线资料差异无统计学意义。平均随访时间(38.00±5.69)个月,利伐沙班组与华法林组1年内大出血事件发生率(0%vs 1.4%,P=0.367)和轻微出血发生率(6.8%vs 9.6%,P=0.561)差异无统计学意义;利伐沙班组术后1年一期通畅率(88.1%vs 72.6%,P=0.028)和2年一期通畅率(81.3%vs 61.7%,P=0.014)均高于华法林组;利伐沙班组在术后Villalta评分(4.67±1.43 vs 7.86±2.51,P=0.001)、症状复发率(15.3%vs 38.3%,P=0.003)和溃疡愈合率(89.5%vs 61.5%,P=0.036)均优于华法林组。结论对于髂静脉支架植入术后的PTS患者,利伐沙班与华法林安全性相似,疗效优于华法林,表现出更高的一期通畅率和更好的临床症状改善率。

Objective To compare the safety and efficacy of anticoagulant therapy of rivaroxaban and warfarin in patients with post-thrombotic syndrome(PTS)after iliac vein stent implantation.Methods A total of 132 PTS patients who underwent iliac vein stent implantation were selected from the 970th Hospital of PLA from January 2017 to December 2020 and were given anticoagulant therapy for 1 year after surgery.They were randomly divided into 59 cases in the rivaroxaban group and 73 cases in the warfarin group.The primary safe outcome was the incidence of hemorrhage within 1 year,the primary effective outcome was the rate of primary stent patency,and the secondary outcome included Villalta score,symptom recurrence rate,and ulcer healing rate.Results There was no significant difference in baseline data between the two groups.The mean follow-up time was(38.00±5.69)months.There was no significant difference in the incidence of major bleeding events(0%vs 1.4%,P=0.367)and minor bleeding events(6.8%vs 9.6%,P=0.561)between the Rivaroxaban and warfarin groups within 1 year.The 1-year patency rate(88.1%vs 72.6%,P=0.028)and 2-year patency rate(81.3%vs 61.7%,P=0.014)in rivaroxaban group were higher than those in warfarin group.The Villalta score(4.67±1.43 vs 7.86±2.51,P=0.001),symptom recurrence rate(15.3%vs 38.3%,P=0.003)and ulcer healing rate(89.5%vs 61.5%,P=0.036)in rivaroxaban group were all better than those in warfarin group.Conclusions For PTS patients undergone iliac vein stenting,rivaroxaban was similar to warfarin in safety and superior to warfarin in efficacy,showing higher primary patency rate and better clinical symptom improvement rate.