非瓣膜性心房颤动患者左心耳封堵术后新型口服抗凝药治疗的疗效与安全性

Efficacy and safety of novel oral anticoagulants for nonvalvular atrial fibrillation patients undergoing left atrial appendage closure

目的分析非瓣膜性心房颤动(NVAF)患者在左心耳封堵术(LAAC)后应用新型口服抗凝药(NOAC抗凝治疗的疗效和安全性。方法本研究为单中心、前瞻性队列研究,纳入成功植入左心耳封堵器的NVAF患者,于LAAC术后给予NOCA(达比加群酯110 mg bid或利伐沙班15 mg qd)或华法林(国际标准化比值维持在2~3)抗凝治疗3个月,随后予阿司匹林联合氯吡格雷治疗至6个月,后阿司匹林长期服用。术后3、6个月经食道超声心动图(TEE)评估器械相关血栓(DRT)的发生情况。结果共纳入患者270例,最终255例完成6个月随访,其中华法林组103例,NOAC组152例。华法林组和NOAC组分别有3例(2.0%)和8例(7.8%)患者发生DRT,NOAC组累积DRT比率低于华法林组(P=0.039,OR=0.247,95%CI:0.065~0.929)。TEE显示NOAC组DRT长度和宽度均小于华法林组[(6.6±1.3)mm vs.(14.0±3.2)mm,P=0.0033;(3.0±1.0)mm vs.(7.5±1.7)mm,P=0.0025]。随访期间,华法林组血栓事件发生率高于NOAC组(8.7%vs.2.6%,P=0.025),2组出血事件发生率无显著差异(1.9%vs.1.3%,P=0.693)。NOAC组再住院率低于华法林组(2.6%vs.12.6%,P=0.002)。结论与华法林相比,NVAF患者LAAC术后选择NOAC抗凝治疗可能更有利于减少血栓事件,且不增加出血风险。

AIM To analyze the efficacy and safety of novel oral anticoagulant(NOAC)anticoagulation therapy for nonvalvular atrial fibrillation(NVAF)patients undergoing left atrial appendage closure(LAAC).METHODS A singlecenter and prospective cohort study was performed among NVAF patients who received anticoagulant therapy after LAAC.All patients were medicated with a 3-month course of NOAC(dabigatran etexilate 110 mg bid or rivaroxaban 15 mg qd)or warfarin(international normalized ratio:2—3)to facilitate device endothelialization,followed by dual antiplatelet therapy until 6 months,then lifelong aspirin after discharge.Repeated transesophageal echocardiography(TEE)was scheduled at 3 and 6 months after LAAC to evaluate device-related thrombosis(DRT)formation on occluders.RESULTS A total of 270 patients were included,and 255 patients completed the 6-month follow-up,including 103 in the warfarin group and 152 in the NOAC group.Eight patients(7.8%)in the warfarin group and three patients(2.0%)in the NOAC group were experiencing DRT events.Cumulative Kaplan-Meier estimates showed that the incidence of DRT was lower in the NOAC group during the 6-month follow-ups(P=0.039,OR=0.247,95%CI:0.065 to 0.929).TEE showed that the length and width of DRT in the NOAC group were significantly lower than that in the warfarin group((6.6±1.3)mm vs.(14.0±3.2)mm,P=0.0033;(3.0±1.0)mm vs.(7.5±1.7)mm,P=0.0025).The incidence of thrombotic events in the warfarin group was higher than that in the NOAC group(8.7%vs.2.6%,P=0.025),and there was no significant difference in the incidence of bleeding events between the two groups(1.9%vs.1.3%,P=0.693).The rate of re-hospitalization was lower in the NOAC group than that in the warfarin group(2.6%vs.12.6%,P=0.002).CONCLUSION Compared with warfarin,NOAC anticoagulation after LAAC in patients with NVAF might be advantageous in reducing thrombotic events,without increasing the risk of hemorrhage.