From Vancouver General Hospital (J.G.A., M.B.), the University of British Columbia (J.G.A., M.W.D., M.B., S.L.), and the Centre for Cardiovascular Innovation (J.G.A., M.W.D.), Vancouver, Montreal Heart Institute, Université de Montréal (J.G.A., L.M.) and McGill University Health Centre (V.E.), Montreal, the University of Ottawa Heart Institute, Ottawa (G.A.W.), Université Laval, Quebec, QC (J.C.), Université de Sherbrooke, Sherbrooke, QC (J.-F.R.), Rouge Valley Centenary Hospital, Scarborough, ON (D.Y.), Western University, London, ON (A.S.), Southlake Regional Health Centre, University of Toronto, Newmarket, ON (Y.K., A.V.), Libin Cardiovascular Institute, University of Calgary, Calgary, AB (C.M.), St. Mary's General Hospital, Kitchener, ON (U.J.), Royal Jubilee Hospital, Victoria, BC (P.N.), Royal Alexandra Hospital, Edmonton, AB (E.L.), McMaster University, Hamilton, ON (G.A.), St. Michael's Hospital, University of Toronto, Toronto (P.A.), Dalhousie University, Halifax, NS (J.S.), and the University of Saskatchewan, Saskatoon, SK (S.W.) - all in Canada.
N Engl J Med. 2021 Jan 28;384(4):305-315. doi: 10.1056/NEJMoa2029980. Epub 2020 Nov 16.
Guidelines recommend a trial of one or more antiarrhythmic drugs before catheter ablation is considered in patients with atrial fibrillation. However, first-line ablation may be more effective in maintaining sinus rhythm.
We randomly assigned 303 patients with symptomatic, paroxysmal, untreated atrial fibrillation to undergo catheter ablation with a cryothermy balloon or to receive antiarrhythmic drug therapy for initial rhythm control. All the patients received an implantable cardiac monitoring device to detect atrial tachyarrhythmia. The follow-up period was 12 months. The primary end point was the first documented recurrence of any atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) between 91 and 365 days after catheter ablation or the initiation of an antiarrhythmic drug. The secondary end points included freedom from symptomatic arrhythmia, the atrial fibrillation burden, and quality of life.
At 1 year, a recurrence of atrial tachyarrhythmia had occurred in 66 of 154 patients (42.9%) assigned to undergo ablation and in 101 of 149 patients (67.8%) assigned to receive antiarrhythmic drugs (hazard ratio, 0.48; 95% confidence interval [CI], 0.35 to 0.66; P<0.001). Symptomatic atrial tachyarrhythmia had recurred in 11.0% of the patients who underwent ablation and in 26.2% of those who received antiarrhythmic drugs (hazard ratio, 0.39; 95% CI, 0.22 to 0.68). The median percentage of time in atrial fibrillation was 0% (interquartile range, 0 to 0.08) with ablation and 0.13% (interquartile range, 0 to 1.60) with antiarrhythmic drugs. Serious adverse events occurred in 5 patients (3.2%) who underwent ablation and in 6 patients (4.0%) who received antiarrhythmic drugs.
Among patients receiving initial treatment for symptomatic, paroxysmal atrial fibrillation, there was a significantly lower rate of atrial fibrillation recurrence with catheter cryoballoon ablation than with antiarrhythmic drug therapy, as assessed by continuous cardiac rhythm monitoring. (Funded by the Cardiac Arrhythmia Network of Canada and others; EARLY-AF ClinicalTrials.gov number, NCT02825979.).
指南建议在考虑对房颤患者进行导管消融之前，先试用一种或多种抗心律失常药物。然而，一线消融可能更有效地维持窦性节律。
我们随机分配 303 名有症状、阵发性、未经治疗的房颤患者，进行冷冻球囊导管消融或接受抗心律失常药物治疗以控制初始节律。所有患者均植入心脏监测装置以检测房性心动过速。随访期为 12 个月。主要终点是导管消融后 91-365 天或开始使用抗心律失常药物后首次记录到任何房性心动过速（房颤、房扑或房性心动过速）的复发。次要终点包括无症状心律失常、房颤负荷和生活质量。
在 1 年时，消融组 154 例患者中有 66 例（42.9%）和抗心律失常药物组 149 例患者中有 101 例（67.8%）发生房性心动过速复发（风险比，0.48；95%置信区间[CI]，0.35 至 0.66；P<0.001）。消融组有 11.0%的患者出现有症状的房性心动过速复发，而抗心律失常药物组有 26.2%的患者出现（风险比，0.39；95%CI，0.22 至 0.68）。房颤中位数时间百分比为 0%（四分位间距，0 至 0.08），消融组为 0.13%（四分位间距，0 至 1.60）。消融组有 5 例（3.2%）患者和抗心律失常药物组有 6 例（4.0%）患者发生严重不良事件。
在接受有症状、阵发性房颤初始治疗的患者中，连续心脏节律监测显示，导管冷冻球囊消融的房颤复发率明显低于抗心律失常药物治疗。（由加拿大心律失常网络等资助；EARLY-AF ClinicalTrials.gov 编号，NCT02825979）。
