年龄与导管消融与药物治疗房颤结局的相关性：CABANA 试验结果。
Association Between Age and Outcomes of Catheter Ablation Versus Medical Therapy for Atrial Fibrillation: Results From the CABANA Trial.
机构信息
Duke Clinical Research Institute, Duke University, Durham, NC (T.D.B., A.G., D.B.M., H.R.A.-K., A.P.S., K.L.L.).
Duke Center for Atrial Fibrillation, Duke Health System, Durham, NC (T.D.B.).
出版信息
Circulation. 2022 Mar 15;145(11):796-804. doi: 10.1161/CIRCULATIONAHA.121.055297. Epub 2021 Dec 22.
BACKGROUND
Observational data suggest that catheter ablation may be safe and effective to treat younger and older patients with atrial fibrillation. No large, randomized trial has examined this issue. This report describes outcomes according to age at entry in the CABANA trial (Catheter Ablation versus Antiarrhythmic Drug Therapy for Atrial Fibrillation).
METHODS
Patients with atrial fibrillation ≥65 years of age, or <65 with ≥1 risk factor for stroke, were randomly assigned to catheter ablation versus drug therapy. The primary outcome was a composite of death, disabling stroke, serious bleeding, or cardiac arrest. Secondary outcomes included all-cause mortality, the composite of mortality or cardiovascular hospitalization, and recurrence of atrial fibrillation. Treatment effect estimates were adjusted for baseline covariables using proportional hazards regression models.
RESULTS
Of 2204 patients randomly assigned in CABANA, 766 (34.8%) were <65 years of age, 1130 (51.3%) were 65 to 74 years of age, and 308 (14.0%) were ≥75 years of age. Catheter ablation was associated with a 43% reduction in the primary outcome for patients <65 years of age (adjusted hazard ratio [aHR], 0.57 [95% CI, 0.30-1.09]), a 21% reduction for 65 to 74 years of age (aHR, 0.79 [95% CI, 0.54-1.16]), and an indeterminate effect for age ≥75 years of age (aHR, 1.39 [95% CI, 0.75-2.58]). Four-year event rates for ablation versus drug therapy across age groups, respectively, were 3.2% versus 7.8%, 7.8% versus 9.6%, and 14.8% versus 9.0%. For every 10-year increase in age, the primary outcome aHR increased (ie, less favorable to ablation) an average of 27% (interaction value=0.215). A similar pattern was seen with all-cause mortality: for every 10-year increase in age, the aHR increased an average of 46% (interaction value=0.111). Atrial fibrillation recurrence rates were lower with ablation than with drug therapy across age subgroups (aHR 0.47, 0.58, and 0.49, respectively). Treatment-related complications were infrequent for both arms (<3%) regardless of age.
CONCLUSIONS
We found age-based variations in clinical outcomes for catheter ablation compared with drug therapy, with the largest relative and absolute benefits of catheter ablation in younger patients. No prognostic benefits for ablation were seen in the oldest patients. No differences were found by age in treatment-related complications or in the relative effectiveness of catheter ablation in preventing recurrent atrial arrhythmias.
REGISTRATION
URL: https://www.
CLINICALTRIALS
gov; Unique identifier: NCT00911508.
背景
观察性数据表明，导管消融术可能对治疗年轻和老年房颤患者是安全且有效的。尚无大型随机试验对此进行研究。本报告描述了 CABANA 试验（导管消融术与抗心律失常药物治疗房颤的比较）中根据入组时的年龄得出的结果。
方法
年龄≥65 岁或＜65 岁但有 1 项以上中风危险因素的房颤患者被随机分配至导管消融术或药物治疗组。主要终点是死亡、致残性中风、严重出血或心脏骤停的复合终点。次要终点包括全因死亡率、死亡率或心血管住院的复合终点以及房颤复发。使用比例风险回归模型，根据基线协变量调整治疗效果估计值。
结果
在 CABANA 试验中随机分配的 2204 例患者中，766 例（34.8%）年龄＜65 岁，1130 例（51.3%）年龄 65-74 岁，308 例（14.0%）年龄≥75 岁。与药物治疗相比，年龄＜65 岁的患者的主要终点发生率降低了 43%（校正后的危险比[ aHR]，0.57 [95%CI，0.30-1.09]），年龄 65-74 岁的患者降低了 21%（aHR，0.79 [95%CI，0.54-1.16]），而年龄≥75 岁的患者的效果不确定（aHR，1.39 [95%CI，0.75-2.58]）。各组中，消融术与药物治疗的 4 年事件发生率分别为 3.2%与 7.8%、7.8%与 9.6%以及 14.8%与 9.0%。每增加 10 岁，主要终点的 aHR 平均增加 27%（即，消融术的获益降低）（交互 值=0.215）。所有原因死亡率也呈现出相似的模式：每增加 10 岁，aHR 平均增加 46%（交互 值=0.111）。与药物治疗相比，消融术在各年龄亚组中均能降低房颤复发率（aHR 分别为 0.47、0.58 和 0.49）。无论年龄大小，两组的治疗相关并发症均较为少见（均＜3%）。
结论
与药物治疗相比，我们发现导管消融术的临床结局存在基于年龄的差异，导管消融术在年轻患者中的相对和绝对获益最大。在年龄最大的患者中未发现导管消融术有预后获益。在治疗相关并发症或导管消融术预防复发性房性心律失常的相对有效性方面，年龄之间无差异。
登记信息
网址：https://www.
临床试验
gov；唯一标识符：NCT00911508。
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