Antithrombotic Therapy after Successful Catheter Ablation for Atrial Fibrillation.

Methods

We conducted an international, open-label, randomized, blinded-outcome-assessment trial involving 1284 patients who had undergone successful catheter ablation for atrial fibrillation at least 1 year earlier and had a CHA2DS2-VASc score (scores range from 0 to 9, with higher scores indicating a higher risk of stroke) of 1 or more (or ≥2 for women or for patients in whom vascular disease was a risk factor).

我们进行了一项国际、开放标签、随机、盲法结果评估试验，涉及1284名至少1年前成功接受心房颤动导管消融治疗且CHA2DS2-VASc评分（评分范围从0到9，分数越高表示中风风险越高）为1分或以上（或女性为2分及以上，或血管疾病是风险因素的患者）的患者。

Patients were randomly assigned to receive either aspirin (at a dose of 70 to 120 mg daily, depending on availability in the local jurisdiction) or rivaroxaban (at a dose of 15 mg) and followed for 3 years.

患者被随机分配接受阿司匹林（剂量为每天70至120毫克，根据当地司法管辖区的可用性而定）或利伐沙班（剂量为15毫克），并被跟踪随访3年。

Magnetic resonance imaging (MRI) of the head was performed after enrollment and at 3 years.

在入组后和3年时进行了头部磁共振成像（MRI）检查。

The primary outcome was a composite of stroke, systemic embolism, or new covert embolic stroke (defined by ≥1 new infarct measuring ≥15 mm on MRI) at 3 years.

主要结果是3年内中风、全身性栓塞或新发隐匿性栓塞性中风（定义为MRI上≥1个新发梗死灶，大小≥15毫米）的复合终点。

Results

A total of 641 patients were assigned to the rivaroxaban group and 643 to the aspirin group.

共有641名患者被分配至利伐沙班组，643名患者被分配至阿司匹林组。

A primary-outcome event occurred in 5 patients (0.31 events per 100 patient-years) in the rivaroxaban group and in 9 patients (0.66 events per 100 patient-years) in the aspirin group (relative risk, 0.56; 95% confidence interval[CI], 0.19 to 1.65; absolute risk difference at 3 years, -0.6 percentage points; 95% CI, -1.8 to 0.5; P = 0.28).

主要终点事件在利伐沙班组的5名患者中发生（每100患者年0.31次事件），而在阿司匹林组的9名患者中发生（每100患者年0.66次事件）（相对风险，0.56；95%置信区间[CI]，0.19至1.65；3年时的绝对风险差异为-0.6个百分点；95% CI，-1.8至0.5；P = 0.28）。

New cerebral infarcts measuring less than 15 mm occurred in 22 of 568 patients (3.9%) in the rivaroxaban group and in 26 of 590 patients (4.4%) in the aspirin group (relative risk, 0.89; 95% CI, 0.51 to 1.55).

新发的脑梗死小于15毫米在利伐沙班组的568名患者中有22例（3.9%），而在阿司匹林组的590名患者中有26例（4.4%）（相对风险，0.89；95% CI，0.51至1.55）。

Fatal or major bleeding (the composite primary safety outcome) had occurred in 10 patients (1.6%) with rivaroxaban and in 4 patients (0.6%) with aspirin (hazard ratio, 2.51; 95% CI, 0.79 to 7.95) at 3 years.

在3年时，致命或主要出血（复合主要安全性结果）在10名（1.6%）使用利伐沙班的患者和4名（0.6%）使用阿司匹林的患者中发生（风险比，2.51；95%置信区间，0.79至7.95）。

Conclusions

Among patients who had had successful catheter ablation for atrial fibrillation at least 1 year earlier and had risk factors for stroke, treatment with rivaroxaban did not result in a significantly lower incidenceof a composite of stroke, systemic embolism, or new covert embolic stroke than treatment with aspirin.

在至少1年前成功进行了心房颤动导管消融术且有中风风险因素的患者中，与阿司匹林治疗相比，利伐沙班治疗并未显著降低中风、全身性栓塞或新发隐匿性栓塞性中风的复合发生率。

(Funded by Bayer and others; OCEAN ClinicalTrials.gov number, NCT02168829.).

(由拜耳等公司资助; OCEAN ClinicalTrials.gov编号, NCT02168829。)