Catheter ablation treatment in patients with drug-refractory atrial fibrillation: a prospective, multi-centre, randomized, controlled study (Catheter Ablation For The Cure Of Atrial Fibrillation Study)
Catheter ablation treatment in patients with drug-refractory atrial fibrillation: a prospective, multi-centre, randomized, controlled study (Catheter Ablation For The Cure Of Atrial Fibrillation Study)
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DOI：
10.1093/eurheartj/ehi583
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发表时间：
2006-01-01
影响因子：
39.3
通讯作者：
Vitale, DF
中科院分区：
文献类型：
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作者：
Stabile, G;Bertaglia, E;Vitale, DF
我们进行了一项多中心、前瞻性、对照，一项随机试验，旨在研究消融治疗对抗心律失常药物治疗在预防阵发性或持续性房颤（AF）患者复发中的作用，其中抗心律失常药物治疗已经失败。方法和结果137例患者随机接受消融和抗心律失常药物治疗（消融组）或单纯抗肿瘤药物治疗（对照组）。在消融组中，患者接受了三尖瓣腔和左下肺静脉（PV）-二尖瓣峡部消融加环肺静脉消融。该研究的主要终点是在1个月的空白期后，在1年的随访期内没有任何持续> 30 s的房性心律失常复发。3例（4.4%）严重并发症与消融相关：1例患者在左心房消融期间发生卒中，另1例患者发生一过性膈神经麻痹，第3例患者发生心包积液，需要进行心包穿刺术。12个月随访后，63/69对照组91.3%的患者至少有一次AF复发，而30/68例患者（44.1%）消融组患者房性心律失常复发率明显高于对照组（P < 0.001）（4名患者患有心房扑动，26例AF患者）结论消融联合抗心律失常药物治疗在预防房性心律失常复发方面上级单纯抗心律失常药物治疗。阵发性或持续性房颤，抗心律失常药物治疗已经失败。
Aims We conducted a multi-centre, prospective, controlled, randomized trial to investigate the adjunctive role of ablation therapy to antiarrhythmic drug therapy in preventing atrial fibrillation (AF) relapses in patients with paroxysmal or persistent AF in whom antiarrhythmic drug therapy had already failed.Methods and results One hundred and thirty seven patients were randomized to ablation and antiarrhythmic drug therapy (ablation group) or antiarrhythmic drug therapy alone (control group). In the ablation group, patients underwent cavo-tricuspid and left inferior pulmonary vein (PV)-mitral isthmus ablation plus circumferential PV ablation. The primary end-point of the study was the absence of any recurrence of atrial arrhythmia lasting > 30 s in the 1-year follow-up period, after 1-month blanking period. Three (4.4%) major complications were related to ablation: one patient had a stroke during left atrium ablation, another suffered transient phrenic paralysis, and the third had a pericardial effusion which required pericardiocentesis. After 12 months of follow-up, 63/69 (91.3%) control group patients had at least one AF recurrence, whereas 30/68 (44.1%) (P < 0.001) ablation group patients had atrial arrhythmia recurrence (four patients had atrial flutter, 26 patients AF).Conclusion Ablation therapy combined with antiarrhythmic drug therapy is superior to antiarrhythmic drug therapy alone in preventing atrial arrhythmia recurrences in patients with paroxysmal or persistent AF in whom antiarrhythmic drug therapy has already failed.