CABANA EQOL Trial

描述(由申请人提供)： 这项由研究人员发起的导管消融与抗心律失常药物治疗房颤(CABANA)试验将检验一项假设，即用于消除心房颤动(AF)的经皮左房导管消融治疗策略优于当前最先进的药物治疗策略，无论是使用心率控制药物还是节律控制药物，均可降低需要治疗的房颤患者的总死亡率(主要终点)和总死亡率、致残性中风、严重出血和心脏骤停(次要终点)的综合终点。其他次要终点将包括房颤复发、生活质量和成本效益。需要这项试验的原因是1)60岁以上伴有症状和发病率的房颤患者数量迅速增加，2)最近多项试验中抗心律失常药物治疗未能维持窦性心律和降低死亡率，3)在没有适当的循证验证的情况下，射频导管消融术在房颤治疗中的应用迅速增加，以及4)房颤对国家医疗成本的影响。 这项140中心的死亡率研究将在3年内随机将3000名患者分为导管消融术(n=1500)和最先进的速率或节律控制药物治疗(n=1500)。每个患者将有1)与确诊患者相似的特征(年龄65岁，或65岁，有中风的1个危险因素，2)有文件证明的房颤保证治疗，以及3)符合导管消融术和2抗心律失常或3率控制药物的资格。患者将每6个月进行一次为期2年(中位数为3.5年)的随访，并将接受重复的电话监测、动态心电图监测和CT/MR检查，以评估治疗的影响。发作性、持续性或永久性房颤患者将检查主要和次要终点，而不考虑年龄或潜在的心脏病。 在接受药物治疗的患者中，预期3.5年的死亡率为&gt；12%，每个治疗组的1500名患者将提供90%的能量来检测总体死亡率相对下降30%，以及&gt；90%的能量来检测综合次要终点的25%的下降。CABANA试验将揭示医疗和消融治疗在不断升级的国家医疗保健困境中的作用，确定治疗的成本和对生活质量的影响，确定治疗对心房形态和功能的影响，并将有助于确定房颤是否是心血管死亡的可改变的危险因素。卡巴纳将是一项里程碑式的试验，将指导治疗并在未来几年塑造AF竞技场的医疗保健政策。

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.