Circulation:CB消融术 vs RF消融术治疗阵发性房颤

2015-08-19 MedSci MedSci原创

目前对于开放式射频(RF)和球囊导管(CB)消融术治疗阵发性房颤(AF)患者肺静脉(PV)隔离的程序安全性和有效性比较缺乏数据。在一项前瞻性,非劣效性研究中315例患者被随机分配到接受RF(n=159)或CB(n=156)消融术。主要终点为无持续性并发症的房性心律失常发生。两组患者数量基本上相当,在RF组有更多的血管疾病患者(8.2% vs CB组2.6%;p=0.028)。在12个月时主要终点R

目前对于开放式射频(RF)和球囊导管(CB)消融术治疗阵发性房颤(AF)患者的肺静脉(PV)隔离程序的安全性和有效性比较缺乏数据。

在一项前瞻性、非劣效性研究中,315例患者被随机分配到接受RF(n=159)或CB(n=156)消融术。主要终点为无持续性并发症的房性心律失常发生。两组患者数量基本上相当,在RF组有更多的血管疾病患者(8.2% vs CB组2.6%;p=0.028)。在12个月时主要终点RF组70.7%的患者达到了主要终点,CB组73.6%的患者达到了主要终点(多个手术成功),其中包括每组有31例再次手术(RF中为19.5% vs CB中为19.9%,P=0.933)。对于意向性治疗(ITT)人群中,CB的非劣效性揭示了预定义的劣效性界值(风险差异[RD]0.029;95%置信区间[Cl]-0.0740至1.32;P<0.001)。在6个月时RF和CB组的单次手术成功概率分别为63.1%和64.1%(单程序成功),研究人员对非劣效也进行了确认(RD 0.010;95%Cl为-0.097至0.116,P=0.002)。手术操作的围手术期并发症在CB组较为频繁(RF组为5.0%,CB组为12.2%,p=0.022),两组的膈神经麻痹也有显著差异(RF为0%,CB组为5.8%,p=0.002)。

这个大型,前瞻性,随机对照研究证实了CB消融术 vs RF消融术治疗阵发性房颤患者的非劣效性。

原始出处:

Armin Luik1,Andrea Radzewitz1,Meinhard Kieser,et al.Cryoballoon versus Open Irrigated Radiofrequency Ablation in Patients With Paroxysmal Atrial Fibrillation,Circulation,2015.8.18

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