From 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, Montreal (J.G.A., L.M., J.C.-T.), the University of Ottawa Heart Institute, Ottawa (G.A.W.), McGill University Health Centre, Montreal (V.E., A.V.), Université Laval, Quebec (J.C.), Université de Sherbrooke, Sherbrooke, QC (J.-F.R.), Rouge Valley Centenary Hospital, Scarborough, ON (D.Y.), University of Western Ontario, London (A.S.), Southlake Regional Health Centre, University of Toronto, Newmarket, ON (Y.K.), Libin Cardiovascular Institute, University of Calgary, Calgary, AB (C.M.), St. Mary's 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 (S.W.) - all in Canada; and Marienhospital Osnabrück, Niedersachsen, Germany (S.K.).
N Engl J Med. 2023 Jan 12;388(2):105-116. doi: 10.1056/NEJMoa2212540. Epub 2022 Nov 7.
Atrial fibrillation is a chronic, progressive disorder, and persistent forms of atrial fibrillation are associated with increased risks of thromboembolism and heart failure. Catheter ablation as initial therapy may modify the pathogenic mechanism of atrial fibrillation and alter progression to persistent atrial fibrillation.
We report the 3-year follow-up of patients with paroxysmal, untreated atrial fibrillation who were enrolled in a trial in which they had been randomly assigned to undergo initial rhythm-control therapy with cryoballoon ablation or to receive antiarrhythmic drug therapy. All the patients had implantable loop recorders placed at the time of trial entry, and evaluation was conducted by means of downloaded daily recordings and in-person visits every 6 months. Data regarding the first episode of persistent atrial fibrillation (lasting ≥7 days or lasting 48 hours to 7 days but requiring cardioversion for termination), recurrent atrial tachyarrhythmia (defined as atrial fibrillation, flutter, or tachycardia lasting ≥30 seconds), the burden of atrial fibrillation (percentage of time in atrial fibrillation), quality-of-life metrics, health care utilization, and safety were collected.
A total of 303 patients were enrolled, with 154 patients assigned to undergo initial rhythm-control therapy with cryoballoon ablation and 149 assigned to receive antiarrhythmic drug therapy. Over 36 months of follow-up, 3 patients (1.9%) in the ablation group had an episode of persistent atrial fibrillation, as compared with 11 patients (7.4%) in the antiarrhythmic drug group (hazard ratio, 0.25; 95% confidence interval [CI], 0.09 to 0.70). Recurrent atrial tachyarrhythmia occurred in 87 patients in the ablation group (56.5%) and in 115 in the antiarrhythmic drug group (77.2%) (hazard ratio, 0.51; 95% CI, 0.38 to 0.67). The median percentage of time in atrial fibrillation was 0.00% (interquartile range, 0.00 to 0.12) in the ablation group and 0.24% (interquartile range, 0.01 to 0.94) in the antiarrhythmic drug group. At 3 years, 8 patients (5.2%) in the ablation group and 25 (16.8%) in the antiarrhythmic drug group had been hospitalized (relative risk, 0.31; 95% CI, 0.14 to 0.66). Serious adverse events occurred in 7 patients (4.5%) in the ablation group and in 15 (10.1%) in the antiarrhythmic drug group.
Initial treatment of paroxysmal atrial fibrillation with catheter cryoballoon ablation was associated with a lower incidence of persistent atrial fibrillation or recurrent atrial tachyarrhythmia over 3 years of follow-up than initial use of antiarrhythmic drugs. (Funded by the Cardiac Arrhythmia Network of Canada and others; EARLY-AF ClinicalTrials.gov number, NCT02825979.).
心房颤动是一种慢性、进行性疾病，持续性心房颤动与血栓栓塞和心力衰竭风险增加有关。作为初始治疗的导管消融可能会改变心房颤动的发病机制，并改变向持续性心房颤动的进展。
我们报告了阵发性、未经治疗的心房颤动患者的 3 年随访结果，这些患者参加了一项试验，他们被随机分配接受冷冻球囊消融的初始节律控制治疗或接受抗心律失常药物治疗。所有患者在试验入组时均植入了可植入的环路记录器，并通过下载的日常记录和每 6 个月的亲自访视进行评估。收集了关于持续性心房颤动（持续时间≥7 天或持续时间 48 小时至 7 天但需要电复律终止）、复发性房性心动过速（定义为心房颤动、扑动或持续时间≥30 秒的心动过速）、心房颤动负担（心房颤动时间百分比）、生活质量指标、医疗保健利用和安全性的首次发作的数据。
共纳入 303 例患者，其中 154 例接受冷冻球囊消融的初始节律控制治疗，149 例接受抗心律失常药物治疗。在 36 个月的随访中，消融组有 3 例（1.9%）患者发生持续性心房颤动，而抗心律失常药物组有 11 例（7.4%）患者发生持续性心房颤动（风险比，0.25；95%置信区间[CI]，0.09 至 0.70）。消融组有 87 例（56.5%）患者发生复发性房性心动过速，抗心律失常药物组有 115 例（77.2%）患者发生复发性房性心动过速（风险比，0.51；95%CI，0.38 至 0.67）。消融组的中位心房颤动时间百分比为 0.00%（四分位距，0.00 至 0.12），抗心律失常药物组为 0.24%（四分位距，0.01 至 0.94）。3 年后，消融组有 8 例（5.2%）患者和抗心律失常药物组有 25 例（16.8%）患者住院（相对风险，0.31；95%CI，0.14 至 0.66）。消融组有 7 例（4.5%）患者和抗心律失常药物组有 15 例（10.1%）患者发生严重不良事件。
与初始使用抗心律失常药物相比，冷冻球囊消融治疗阵发性心房颤动在 3 年的随访中持续性心房颤动或复发性房性心动过速的发生率较低。（由加拿大心律失常网络等资助；EARLY-AF ClinicalTrials.gov 编号，NCT02825979。）
