Effect of Catheter Ablation vs Antiarrhythmic Drug Therapy on Mortality, Stroke, Bleeding, and Cardiac Arrest Among Patients With Atrial Fibrillation The CABANA Randomized Clinical Trial
Effect of Catheter Ablation vs Antiarrhythmic Drug Therapy on Mortality, Stroke, Bleeding, and Cardiac Arrest Among Patients With Atrial Fibrillation The CABANA Randomized Clinical Trial
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DOI：
10.1001/jama.2019.0693
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发表时间：
2019-04-02
影响因子：
120.7
通讯作者：
Lee, Kerry L.
中科院分区：
文献类型：
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作者：
Packer, Douglas L.;Mark, Daniel B.;Lee, Kerry L.
重要性导管消融术在恢复心房颤动（AF）窦性心律方面是有效的，但其对长期死亡率和卒中风险的影响尚不确定。目的确定导管消融术是否比常规药物治疗更有效地改善AF的结局。设计、设置和参与者导管消融术与抗心律失常药物治疗心房颤动试验是一项由起搏器启动的、开放标签、多中心、随机试验，涉及10个国家的126个中心。从2009年11月至2016年4月，共招募了2204例年龄≥ 65岁或小于65岁且有1个或多个卒中风险因素的症状性房颤患者，随访至2017年12月31日。（n = 1108）接受了肺静脉隔离，根据临床试验机构研究者的判断进行了额外的消融手术。药物治疗组（n = 1096）接受标准的节奏和/或率控制药物的同期guidelines.Main Outcomes AND Measures的指导下，主要终点是死亡，致残性中风，严重出血，或心脏骤停的复合。在13个预先设定的次要终点中，有3个包括在本报告中：全因死亡率;总死亡率或心血管住院率;和AF复发率。结果在随机分配的2204例患者中（中位年龄68岁; 37.2%女性; 42.9%阵发性AF和57.1%持续性AF），89.3%完成了试验。在分配接受导管消融的患者中，1006例（90.8%）接受了手术。在分配接受药物治疗的患者中，301例（27.5%）最终接受了导管消融。在意向治疗分析中，中位随访时间为48.5个月，消融组8.0%（n = 89）的患者发生主要终点，药物治疗组9.2%（n = 101）的患者发生主要终点（风险比[HR]，0.86 [95%CI，0.65-1.15]; P = 0.30）。在次要终点中，消融组和药物治疗组的全因死亡率分别为5.2%和6.1（HR，0.85 [95% CI，0.60-1.21]; P = 0.38），死亡或心血管住院率为51.7% vs 58.1%（HR，0.83 [95%CI，0.74-0.93]; P = 0.001），房颤复发率为49.9% vs 69.5%（HR，0.52 [95%CI，0.45-0.60]; P
IMPORTANCE Catheter ablation is effective in restoring sinus rhythm in atrial fibrillation (AF), but its effects on long-term mortality and stroke risk are uncertain.OBJECTIVE To determine whether catheter ablation is more effective than conventional medical therapy for improving outcomes in AF.DESIGN, SETTING, AND PARTICIPANTS The Catheter Ablation vs Antiarrhythmic Drug Therapy for Atrial Fibrillation trial is an investigator-initiated, open-label, multicenter, randomized trial involving 126 centers in 10 countries. A total of 2204 symptomatic patients with AF aged 65 years and older or younger than 65 years with 1 or more risk factors for stroke were enrolled from November 2009 to April 2016, with follow-up through December 31, 2017.INTERVENTIONS The catheter ablation group (n = 1108) underwent pulmonary vein isolation, with additional ablative procedures at the discretion of site investigators. The drug therapy group (n = 1096) received standard rhythm and/or rate control drugs guided by contemporaneous guidelines.MAIN OUTCOMES AND MEASURES The primary end point was a composite of death, disabling stroke, serious bleeding, or cardiac arrest. Among 13 prespecified secondary end points, 3 are included in this report: all-cause mortality; total mortality or cardiovascular hospitalization; and AF recurrence.RESULTS Of the 2204 patients randomized (median age, 68 years; 37.2% female; 42.9% had paroxysmal AF and 57.1% had persistent AF), 89.3% completed the trial. Of the patients assigned to catheter ablation, 1006 (90.8%) underwent the procedure. Of the patients assigned to drug therapy, 301 (27.5%) ultimately received catheter ablation. In the intention-to-treat analysis, over a median follow-up of 48.5 months, the primary end point occurred in 8.0% (n = 89) of patients in the ablation group vs 9.2%(n = 101) of patients in the drug therapy group (hazard ratio [HR], 0.86 [95% CI, 0.65-1.15]; P =.30). Among the secondary end points, outcomes in the ablation group vs the drug therapy group, respectively, were 5.2% vs 6.1% for all-cause mortality (HR, 0.85 [95% CI, 0.60-1.21]; P =.38), 51.7% vs 58.1% for death or cardiovascular hospitalization (HR, 0.83 [95% CI, 0.74-0.93]; P =.001), and 49.9% vs 69.5% for AF recurrence (HR, 0.52 [95% CI, 0.45-0.60]; P