左心耳封堵术与口服利伐沙班治疗高出血风险非瓣膜性心房颤动患者短期内安全性及有效性的临床分析

Clinical analysis of short-term safety and efficacy of left atrial appendage closure and oral rivaroxaban in patients with non-valvular atrial fibrillation with high blood risk

目的对比分析左心耳封堵术与口服利伐沙班治疗高出血风险非瓣膜性心房颤动患者短期内的安全性及有效性。方法选取江门市人民医院2020年4月1日至2022年8月31日收治的出血评分为高危的非瓣膜性心房颤动且同意并成功行左心耳封堵术治疗的患者53例作为实验组,选取同期收治的出血评分为高危的非瓣膜性心房颤动且同意口服利伐沙班抗凝治疗的患者53例作为对照组,通过门诊或电话方式在左心耳封堵术后或开始口服抗凝药物后3个月、6个月、12个月对患者进行随访,比较两组患者在左心耳封堵术后或口服抗凝药后3个月、6个月、12个月的有效性终点事件、安全性终点事件是否存在差异。结果2组患者在3个月随访时有效性终点事件(P=1.000)、安全性终点事件(P=0.727)无统计学差异;在6个月随访时有效性终点事件(P=0.727)、安全性终点事件(P=0.321)无统计学差异;在12个月随访时有效性终点事件无统计学差异(P=0.587),安全性终点事件有统计学差异(P=0.027)。Kaplan-Meier生存分析结果显示:两组患者在3个月(P=1.000)、6个月(P=0.744)、12个月(P=0.606)随访时有效性终点事件的生存率无明显差异;两组患者在3个月随访时,安全性终点事件的生存率无明显差异(P=0.743);6个月随访时,实验组安全性终点事件的生存率大于对照组,差异无统计学意义(P=0.344);12个月随访时,实验组安全性终点事件的生存率大于对照组,差异有统计学意义(P=0.040)。结论左心耳封堵术短期内有效性与口服利伐沙班相当,安全性优于口服利伐沙班。

Objective To compare and analyze the short-term safety and effectiveness of left atrial appendage occlusion versus oral rivaroxaban treatment for high-bleeding risk non-valvular atrial fibrillation patients.Methods 53 patients with high-bleeding risk non-valvular atrial fibrillation who agreed and successfully underwent left atrial appendage occlusion treatment in Jiangmen People's Hospital from April 1,2020,to August 31,2022,were selected as the experimental group.Another 53 patients with high-bleeding risk non-valvular atrial fibrillation who agreed and received oral rivaroxaban anticoagulant treatment during the same period were selected as the control group.Patients were followed up through outpatient visits or phone calls at 3 months,6 months,and 12 months after left atrial appendage occlusion or initiation of oral anticoagulant therapy.The differences in effectiveness endpoint events and safety endpoint events were compared between the two groups at 3 months,6 months,and 12 months after left atrial appendage occlusion or oral anticoagulant therapy.Results There were no significant differences in the effectiveness endpoint events(P=1.000)and safety endpoint events(P=0.727)between the two groups at the 3-month follow-up.At the 6-month follow-up,there were no significant differences in the effectiveness endpoint events(P=0.727)and safety endpoint events(P=0.321).At the 12-month follow-up,there was no significant difference in the effectiveness endpoint events(P=0.587),but there was a significant difference in the safety endpoint events(P=0.027).Kaplan-Meier survival analysis showed that there were no significant differences in the survival rates of effectiveness endpoint events between the two groups at 3 months(P=1.000),6 months(P=0.744),and 12 months(P=0.606).At the 3-month follow-up,there was no significant difference in the survival rate of safety endpoint events between the two groups(P=0.743).At the 6-month follow-up,the survival rate of safety endpoint events in the experimental group was higher than that in the control group,but there was no significant difference(P=0.344).At the 12-month follow-up,the survival rate of safety endpoint events in the experimental group was higher than that in the control group,and the difference was statistically significant(P=0.040).Conclusion Left atrial appendage occlusion is equally effective to oral rivaroxaban in the short term and is safer than oral rivaroxaban.