Ablation Versus Drug Therapy for Atrial Fibrillation in Heart Failure: Results From the CABANA Trial.
Ablation Versus Drug Therapy for Atrial Fibrillation in Heart Failure: Results From the CABANA Trial.
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DOI：
10.1161/circulationaha.120.050991
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发表时间：
2021-04-06
期刊：
影响因子：
37.8
通讯作者：
CABANA Investigators
中科院分区：
文献类型：
--
作者：
Packer DL;Piccini JP;Monahan KH;Al-Khalidi HR;Silverstein AP;Noseworthy PA;Poole JE;Bahnson TD;Lee KL;Mark DB;CABANA Investigators
在心力衰竭（HF）和房颤（AF）患者中，多项临床试验报告了导管消融术改善的结局，包括无AF复发、生活质量（QOL）和生存率。本报告描述了入组房颤导管消融与抗心律失常药物治疗（CABANA）试验的房颤伴HF患者的治疗相关结局。CABANA将126个部位的2204例≥65岁或<65岁且有≥1个卒中风险因素的AF患者随机分配至肺静脉隔离消融或药物治疗（包括心率/节律控制药物）。其中，778例（35%）基线时NYHA分级≥ II级，构成本报告的受试者。CABANA的主要终点是死亡、致残性卒中、严重出血或心脏骤停的复合终点。在CABANA入组的778例HF患者中，378例被分配接受消融治疗，400例接受药物治疗。571例患者（73%）的基线射血分数（EF）可用，其中9.3%的EF <40%，而11.7%的EF在40- 50%之间。在意向治疗分析中，消融组的主要复合终点相对减少了36（风险比[HR] 0.64; 95%置信区间[CI]，0.41至0.99），全因死亡率相对降低43%（HR 0.57; 95% CI，0.33 - 0.96），与单独药物治疗相比，中位随访时间为48.5个月。消融术降低了AF复发率（HR 0.56; 95% CI，0.42 - 0.74）。整个60个月随访期间平均的AF对生活质量影响（AFEQT）总评分的校正平均差异为5.0分，有利于消融组（95% CI，2.5至7.4分），马约AF特异性症状量表（MAFSI）频率评分差异为-2.0分，有利于消融组（95% CI，-2.9至-1.2）。在CABANA入组的房颤患者中，在进入试验时临床诊断为稳定性心力衰竭，导管消融术相对于药物治疗在生存率、无AF复发率和生活质量方面产生了具有临床意义的改善。这些结果，在一个队列中获得的大多数人保留左心室功能，需要独立的试验验证。ClinicalTrials.gov标识符：NCT 0091150。 https://www.clinicaltrials.gov/ct2/show/NCT00911508
In patients with heart failure (HF) and atrial fibrillation (AF), severa clinical trials have reported improved outcomes, including freedom from AF recurrence, quality of life (QOL), and survival, with catheter ablation. This report describes the treatment-related outcomes of the AF patients with HF enrolled in the Catheter Ablation vs Antiarrhythmic Drug Therapy for Atrial Fibrillation (CABANA) trial. CABANA randomized 2204 patients with AF who were ≥65 years old or <65 with ≥1 risk factor for stroke at 126 sites to ablation with pulmonary vein isolation or drug therapy including rate/rhythm control drugs. Of these, 778 (35%) had NYHA class ≥ II at baseline and form the subject of this report. The CABANA primary endpoint was a composite of death, disabling stroke, serious bleeding, or cardiac arrest. Of the 778 HF patients enrolled in CABANA, 378 were assigned to ablation and 400 to drug therapy. Ejection fraction (EF) at baseline was available for 571 patients (73%) and 9.3% of these had an EF <40%, while 11.7% had EFs between 40–50%. In the intention-to-treat analysis, the ablation arm had a 36% relative reduction in the primary composite endpoint (hazard ratio [HR] 0.64; 95% confidence interval [CI], 0.41 to 0.99) and a 43% relative reduction in all-cause mortality (HR 0.57; 95% CI, 0.33 to 0.96) compared to drug therapy alone over a median follow-up of 48.5 months. AF recurrence was decreased with ablation (HR 0.56; 95% CI, 0.42 to 0.74). The adjusted mean difference for the AF Effect on QOL (AFEQT) summary score averaged over the entire 60-month follow-up was 5.0 points favoring the ablation arm (95% CI, 2.5 to 7.4 points), and the Mayo AF-specific Symptom Inventory (MAFSI) frequency score difference was −2.0 points favoring ablation (95% CI, −2.9 to −1.2). In patients with atrial fibrillation enrolled in CABANA who had clinically diagnosed stable heart failure at trial entry, catheter ablation produced clinically important improvements in survival, freedom from AF recurrence, and quality of life relative to drug therapy. These results, obtained in a cohort most of whom had preserved left ventricular function, require independent trial verification. ClinicalTrials.gov Identifier: NCT0091150. https://www.clinicaltrials.gov/ct2/show/NCT00911508