Department of Medical Science and Cardiology, Uppsala University, Uppsala, Sweden.
Department of Molecular and Clinical Medicine/Cardiology, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Sweden.
JAMA. 2019 Mar 19;321(11):1059-1068. doi: 10.1001/jama.2019.0335.
Quality of life is not a standard primary outcome in ablation trials, even though symptoms drive the indication.
To assess quality of life with catheter ablation vs antiarrhythmic medication at 12 months in patients with atrial fibrillation.
DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial at 4 university hospitals in Sweden and 1 in Finland of 155 patients aged 30-70 years with more than 6 months of atrial fibrillation and treatment failure with 1 antiarrhythmic drug or β-blocker, with 4-year follow-up. Study dates were July 2008-September 2017. Major exclusions were ejection fraction <35%, left atrial diameter >60 mm, ventricular pacing dependency, and previous ablation.
Pulmonary vein isolation ablation (n = 79) or previously untested antiarrhythmic drugs (n = 76).
Primary outcome was the General Health subscale score (Medical Outcomes Study 36-Item Short-Form Health Survey) at baseline and 12 months, assessed unblinded (range, 0 [worst] to 100 [best]). There were 26 secondary outcomes, including atrial fibrillation burden (% of time) from baseline to 12 months, measured by implantable cardiac monitors. The first 3 months were excluded from rhythm analysis.
Among 155 randomized patients (mean age, 56.1 years; 22.6% women), 97% completed the trial. Of 79 patients randomized to receive ablation, 75 underwent ablation, including 2 who crossed over to medication and 14 who underwent repeated ablation procedures. Of 76 patients randomized to receive antiarrhythmic medication, 74 received it, including 8 who crossed over to ablation and 43 for whom the first drug used failed. General Health score increased from 61.8 to 73.9 points in the ablation group vs 62.7 to 65.4 points in the medication group (between-group difference, 8.9 points; 95% CI, 3.1-14.7; P = .003). Of 26 secondary end points, 5 were analyzed; 2 were null and 2 were statistically significant, including decrease in atrial fibrillation burden (from 24.9% to 5.5% in the ablation group vs 23.3% to 11.5% in the medication group; difference -6.8% [95% CI, -12.9% to -0.7%]; P = .03). Of the Health Survey subscales, 5 of 7 improved significantly. Most common adverse events were urosepsis (5.1%) in the ablation group and atrial tachycardia (3.9%) in the medication group.
Among patients with symptomatic atrial fibrillation despite use of antiarrhythmic medication, the improvement in quality of life at 12 months was greater for those treated with catheter ablation compared with antiarrhythmic medication. Although the study was limited by absence of blinding, catheter ablation may offer an advantage for quality of life.
clinicaltrialsregister.eu Identifier: 2008-001384-11.
生活质量并不是消融试验的主要标准结局，尽管症状是决定消融的主要原因。
评估在患有心房颤动的患者中，导管消融与抗心律失常药物在 12 个月时的生活质量。
设计、地点和参与者：在瑞典的 4 所大学医院和芬兰的 1 所医院进行的随机临床试验，共纳入 155 名年龄在 30-70 岁之间、患有心房颤动且 1 种抗心律失常药物或β受体阻滞剂治疗失败的患者，随访 4 年。研究日期为 2008 年 7 月至 2017 年 9 月。主要排除标准为射血分数<35%、左心房直径>60mm、心室起搏依赖和既往消融。
肺静脉隔离消融（n=79）或未经测试的抗心律失常药物（n=76）。
主要结局为基线和 12 个月时的一般健康量表评分（医疗结果研究 36 项简明健康调查），采用盲法评估（范围为 0[最差]至 100[最佳]）。共有 26 项次要结局，包括植入式心脏监测器测量的从基线到 12 个月的心房颤动负担（%时间）。节律分析排除前 3 个月。
在 155 名随机患者中（平均年龄 56.1 岁；22.6%为女性），97%完成了试验。在 79 名被随机分配接受消融的患者中，75 名患者接受了消融，包括 2 名交叉至药物治疗的患者和 14 名接受重复消融的患者。在 76 名被随机分配接受抗心律失常药物治疗的患者中，74 名患者接受了药物治疗，包括 8 名交叉至消融的患者和 43 名首选用药失败的患者。消融组的一般健康评分从 61.8 分增加到 73.9 分，而药物组从 62.7 分增加到 65.4 分（组间差异，8.9 分；95%置信区间，3.1-14.7；P=0.003）。在 26 个次要终点中，有 5 个进行了分析；其中 2 个为无效，2 个为统计学显著，包括心房颤动负担减少（从消融组的 24.9%降至 5.5%，药物组从 23.3%降至 11.5%；差异-6.8%[95%置信区间，-12.9%至-0.7%]；P=0.03）。在健康调查量表中，有 5 个得到了显著改善。最常见的不良事件是消融组的尿脓毒症（5.1%）和药物组的房性心动过速（3.9%）。
在接受抗心律失常药物治疗仍有症状的心房颤动患者中，与抗心律失常药物治疗相比，导管消融治疗的生活质量改善在 12 个月时更为显著。尽管该研究存在缺乏盲法的局限性，但导管消融可能在生活质量方面具有优势。
clinicaltrialsregister.eu 标识符：2008-001384-11。
