University of Florida， Box 100277， 1600 SW Archer Rd， Gainesville， FL 32610， USA. curtisa@medicine.ufl.edu
BACKGROUND: The AFFIRM Study was a randomized multicenter comparison of 2 treatment strategies， rate-control versus rhythm-control， in high-risk patients with atrial fibrillation (AF). The primary outcome of the trial showed no overall difference in survival between strategies. However， there may be important patient subgroups for which there are identifiable differences in outcome with 1 of the 2 strategies.
METHODS AND RESULTS: Subgroups that were prespecified for analysis from the main AFFIRM Study were age， sex， coronary artery disease (CAD)， hypertension， congestive heart failure (CHF)， left ventricular ejection fraction (LVEF)， rhythm at randomization， first episode of AF， and duration of the qualifying episode of AF. Baseline characteristics were analyzed for each subgroup. Adjusted hazard ratios for each subgroup and for each stratum were generated using Cox models， and these models were used to determine whether treatment strategy affected overall survival differentially by subgroup. Adjusted survival was worse for patients > or =65 years and for patients with a history of CHF， CAD， or an abnormal LVEF. In the adjusted analyses， the effect of treatment strategy was similar within all of the prespecified subgroups. When each subgroup stratum was analyzed separately， patients > or =65 years and patients without a history of CHF had significantly better outcome with rate-control therapy (each P < .01).
CONCLUSIONS: Overall， treatment effect for rate control versus rhythm control was the same within each subgroup. However， certain selected patient categories may have better survival with one particular strategy for management of AF.
目的： 鉴于AFFIRM研究中，随机分配为心率控制或心律控制的房颤患者的生存率和事件发生率均没有出现差异，本项AFFIRM研究的亚组研究的目的在于检验对房颤患者进行心率控制或心律控制，其对于患者的生活质量（QoL）影响相同的无效假说。
方法： 随机选择56处（25%）AFFIRM研究地点进入AFFIRM QoL亚组研究中。进行评估的手段包括：（1）自觉健康状况；（2）生活Cantril阶梯；（3）简易格式36调查；（4）指数；（5）症状列表：发作频率和严重程度。在基线时、2个月、12个月以及以后每隔1年收集数据； 在4年随访结束后报告数据。
结果： AFFIRM研究中进行QoL研究的患者的基本特征与其余的AFFIRM研究患者基本相似。心率控制组和心律控制组在所有时间点上的评分均接近。无论当前心律是窦性心律还是房颤，其评分均接近。在两组患者中，评分从初始时间到随后时间点的升高也都接近。这些改善随时间的推移不再增加。
结论： 接受心率控制策略和心律控制策略治疗患者的QoL有可比性。并且，窦性心律和房颤下的QoL也相似。试图通过恢复窦性心律以提高QoL的努力一般不会成功。