外科左心耳切除术与长期华法林在心房颤动患者卒中预防安全及有效性的比较

Surgical left atrial appendage exclusion versus long-term warfarin therapy in patients with atrial fibrillation

目的:评估左心耳切除(LAAO)与华法林长期抗凝在非瓣膜性心房颤动(NVAF)患者卒中预防方面的有效性及安全性。方法:观察性的队列研究评估左心耳切除的有效性及安全性。入选492例CHADS2评分至少1分的非瓣膜性心房颤动患者。左心耳切除组257例,华法林抗凝组235例。评估2个有效性终点及2个安全性终点。结果:24个月时,外科组的第一个有效性复合终点(包括卒中、全身栓塞和死亡)每百人每年为1.8,华法林组为4.3(HR:0.42,95%CI:0.19~0.93,P=0.033)。第二个疗效终点(卒中和系统性栓塞,不包括术后前7 d)每百人每年的发生率为1.0,华法林组为3.4(HR:0.30,95%CI:0.11~0.82,P=0.019)。第1个安全终点出血发生率为1.6 vs.4.4(HR:0.38;95%CI:0.17~0.87,P=0.022)。手术组第一周手术并发症发生率为1.17%。结论:本研究显示胸腔镜下左心房附件闭塞术预防脑卒中优于华法林。手术组的出血风险也明显降低。手术并发症发生率低,均发生在医院,均未发生严重后果。

Abjective:The goal of this prospective cohort study was to assess the safety and efficacy of thoracoscopic left atrial appendage(LAA)occlusion for stroke prevention in patients with nonvalvular atrial fibrillation(NVAF)compared with long-term warfarin therapy.Background:Thoracoscopic LAA occlusion is an alternative treatment for stroke prevention in patients with atrial fibrillation.Prospective study comparing thora-coscopic LAA occlusion and warfarin therapy is still lacking.Methods:492 NVAF Patients were enrolled.257 patients were treated with thoracoscopic LAA occlusion and 235 with long-term warfarin therapy.Results:At 24 months,the rate of the first efficacy endpoint(composite of stroke,systemic embolism and death)was 0.018 in the surgical group versus 0.043 in the warfarin group(HR:0.4295%CI:0.19-0.93,P=0.033).The rate of the second efficacy endpoint(stroke and systemic embolism excluding the first 7 days after procedure)was 0.010 versus 0.034(HR:0.30,95%CI:0.11-0.82,P=0.019).The rate of the first safety endpoint of bleeding was 0.016 versus 0.044(HR:0.38;95%CI:0.17-0.87,P=0.022).The incidence of surgical complications during the first week in the surgical group was 1.17%.Conclusions:This study showed that thoracoscopic LAA occlusion was superior to warfarin for stroke prevention.The surgical group also had significantly lower bleeding risk.The incidence of surgical complications was low,and all occurred in hospital without causing serious outcomes.