CABANA EQOL Trial

描述（由申请人提供）： 这位由检察官发起的，房颤导管消融术与抗心律失常药物治疗（CABANA）试验将检验以下假设：经皮左心房导管消融术消除房颤（AF）的治疗策略在降低总死亡率方面优于当前最先进的心率控制或节律控制药物药物治疗策略（上级）（主要终点）和降低未接受治疗或治疗不完全的AF预防治疗患者的总死亡率、致残性卒中、严重出血和心脏骤停（次要终点）的复合终点。其他次要终点将包括AF复发、生活质量和成本效益。对本试验的需求源于：1）伴有症状和发病率的>60岁房颤患者数量迅速增加，2）在最近的多项试验中，抗心律失常药物治疗未能维持窦性心律并降低死亡率，3）射频导管消融治疗房颤的应用迅速增加，但没有适当的循证验证，以及4）AF对国家医疗保健费用的影响。 这项140个中心的死亡率研究将在3年内将3000例患者随机分配至导管消融（n=1500）与最新技术水平的心率或节律控制药物治疗（n=1500）。每位患者将具有1）与AFFIRM患者相似的特征（年龄&gt;65岁，或<65 with >1个卒中风险因素，2）记录的AF预防治疗，以及3）导管消融和&gt;2种抗心律失常或&gt;3种心率控制药物的资格。患者将每6个月随访一次，持续&gt;2年（中位数3.5年），并将接受重复的电话监测、霍尔特监测和CT/MR研究，以评估治疗的影响。将在阵发性、持续性或永久性AF患者中检查主要和次要终点，不考虑年龄或基础心脏病。 药物治疗患者的预期3.5年死亡率&gt;12%，每个治疗组1500例患者将提供90%的把握度检测总体死亡率相对降低30%，并提供&gt;90%的把握度检测复合次要终点降低25%。CABANA试验将揭示药物和消融治疗在不断升级的国家医疗保健困境中的作用，确定治疗对生活质量的成本和影响，确定治疗对心房形态和功能的影响，并将有助于确定AF是否是心血管死亡率的可改变风险因素。CABANA将是一项具有里程碑意义的试验，将在未来几年内指导AF竞技场的治疗和制定医疗保健政策。

DESCRIPTION (provided by applicant): The investigator-initiated, Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation (CABANA) Trial will test the hypothesis that the treatment strategy of percutaneous left atrial catheter ablation for the purpose of eliminating atrial fibrillation (AF) is superior to current state-of-the-art pharmacologic therapy with either rate control or rhythm control drugs for reducing total mortality (primary endpoint) and decreasing the composite endpoint of total mortality, disabling stroke, serious bleeding and cardiac arrest (secondary endpoint) in patients with untreated or incompletely treated AF warranting therapy. Additional secondary endpoints will include AF recurrence and quality of life and cost effectiveness. The need for this trial arises out of 1) the rapidly increasing number of patients >60 years of age with AF accompanied by symptoms and morbidity, 2) the failure of anti-arrhythmic drug therapy in multiple recent trials to maintain sinus rhythm and reduce mortality, 3) the rapidly increasing application of radiofrequency catheter ablation for AF without appropriate evidence-based validation, and 4) the resulting impact of AF on national health care costs. This 140-center mortality study will randomize 3000 patients over 3 years to a strategy of catheter ablation (n=1500) vs. state-of-the-art rate or rhythm control drug therapy (n=1500). Each patient will have 1) characteristics similar to AFFIRM patients (age >65, or <65 with >1 risk factor for stroke, 2) documented AF warranting treatment, and 3) eligibility for both catheter ablation and >2 anti-arrhythmic or >3 rate control drugs. Patients will be followed every 6 months for >2 yrs (median 3.5 yrs) and will undergo repeat trans-telephonic monitoring, Holter monitoring, and CT/MR studies to assess the impact of treatment. The primary and secondary endpoints will be examined in pts with paroxysmal, persistent, or permanent AF, without regard to age or underlying heart disease. With an anticipated 3.5 year mortality rate of >12% in drug treated patients, 1500 patients in each treatment arm will provide 90% power for detecting a 30% relative reduction in overall mortality and >90% power for detecting a 25% reduction in the composite secondary endpoint. The CABANA trial will disclose the role of medical and ablative therapies for an ever-escalating national healthcare dilemma, ascertain the cost and influence of therapy on quality of life, establish the impact of therapy on atrial morphology and function, and will help determine if AF is a modifiable risk factor for cardiovascular mortality. CABANA will be a landmark trial that will guide therapy and shape health care policy in the AF arena for years to come.