BACKGROUND In the ARTESiA trial (Apixaban for the Reduction of Thromboembolism in Patients With Device-Detected Subclinical Atrial Fibrillation), apixaban, compared with aspirin, reduced stroke or systemic embolism in patients with device-detected subclinical atrial fibrillation (SCAF). Clinical guidelines recommend considering SCAF episode duration when deciding whether to prescribe oral anticoagulation for this population. METHODS We performed a retrospective cohort study in ARTESiA. Using Cox regression adjusted for CHA2DS2-VASc score and treatment allocation (apixaban or aspirin), we assessed frequency of SCAF episodes and duration of the longest SCAF episode in the 6 months before randomization as predictors of stroke risk and of apixaban treatment effect. RESULTS Among 3986 patients with complete baseline SCAF data, 703 (17.6%) had no SCAF episode ≥6 minutes in the 6 months before enrollment. Among 3283 patients (82.4%) with ≥1 episode of SCAF ≥6 minutes in the 6 months before enrollment, 2542 (77.4%) had up to 5 episodes, and 741 (22.6%) had ≥6 episodes. The longest episode lasted <1 hour in 1030 patients (31.4%), 1 to <6 hours in 1421 patients (43.3%), and >6 hours in 832 patients (25.3%). Higher baseline SCAF frequency was not associated with increased risk of stroke or systemic embolism: 1.1% for 1 to 5 episodes versus 1.2%/patient-year for ≥6 episodes (adjusted hazard ratio, 0.89 [95% CI, 0.59-1.34]). In an exploratory analysis, patients with previous SCAF but no episode ≥6 minutes in the 6 months before enrollment had a lower risk of stroke or systemic embolism than patients with at least one episode during that period (0.5% versus 1.1%/patient-year; adjusted hazard ratio, 0.48 [95% CI, 0.27-0.85]). The frequency of SCAF did not modify the reduction in stroke or systemic embolism with apixaban (Pinteraction=0.1). The duration of the longest SCAF episode in the 6 months before enrollment was not associated with the risk of stroke or systemic embolism during follow-up (<1 hour: 1.0%/patient-year [reference]; 1-6 hours: 1.2%/patient-year [adjusted hazard ratio, 1.27 (95% CI, 0.85-1.90)]; >6 hours: 1.0%/patient-year [adjusted hazard ratio, 1.02 (95% CI, 0.63-1.66)]). SCAF duration did not modify the reduction in stroke or systemic embolism with apixaban (Ptrend=0.1). CONCLUSIONS In ARTESiA, baseline SCAF frequency and longest episode duration were not associated with risk of stroke or systemic embolism and did not modify the effect of apixaban on reduction of stroke or systemic embolism. REGISTRATION URL: https://www.clinicaltrials.gov; Unique identifier: NCT01938248.

中文翻译：

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根据亚临床心房颤动的基线频率和持续时间的中风或全身性栓塞风险：来自 ARTESiA 试验的见解。


背景 在 ARTESiA 试验 （阿哌沙班减少设备检测到的亚临床心房颤动患者的血栓栓塞） 中，与阿司匹林相比，阿哌沙班减少了设备检测到的亚临床心房颤动 （SCAF） 患者的中风或全身性栓塞。临床指南建议在决定是否为该人群开具口服抗凝药时，应考虑 SCAF 发作持续时间。方法 我们在 ARTESiA 中进行了一项回顾性队列研究。使用针对 CHA2DS2-VASc 评分和治疗分配 （阿哌沙班或阿司匹林） 调整的 Cox 回归，我们评估了随机分组前 6 个月内 SCAF 发作的频率和最长 SCAF 发作的持续时间，作为中风风险和阿哌沙班治疗效果的预测因子。结果 在具有完整基线 SCAF 数据的 3986 例患者中，703 例 （17.6%） 在入组前 6 个月内 ≥6 分钟无 SCAF 发作。在入组前 6 个月内 ≥1 次 SCAF 发作 ≥6 分钟的 3283 例患者中，2542 例 （77.4%） 发作长达 5 次，741 例 （22.6%） 发作 ≥6 次。最长发作时间在 1030 例患者 （31.4%） 中持续 <1 小时，在 1421 例患者 （43.3%） 中持续 1 至 <6 小时，在 832 例患者 （25.3%） 中持续 >6 小时。较高的基线 SCAF 频率与卒中或全身性栓塞的风险增加无关：1 至 5 次发作为 1.1%，而 ≥6 次发作为 1.2%/患者年 （校正风险比，0.89 [95% CI，0.59-1.34]）。在一项探索性分析中，既往有 SCAF 但在入组前 6 个月内 ≥6 分钟内无发作的患者发生卒中或全身性栓塞的风险低于在此期间至少发作一次的患者 （0.5% 对 1.1%/患者年;调整后风险比，0.48 [95% CI，0.27-0.85]）。 SCAF 的频率不会改变阿哌沙班中风或全身性栓塞的减少 （Pinteraction=0.1）。入组前 6 个月内最长 SCAF 发作的持续时间与随访期间发生卒中或全身性栓塞的风险无关（<1 小时：1.0%/患者年 [参考];1-6 小时：1.2%/患者年 [调整后的风险比，1.27 （95% CI，0.85-1.90）];>6 小时：1.0%/患者年 [调整后的风险比，1.02 （95% CI，0.63-1.66）]）。SCAF 持续时间没有改变阿哌沙班卒中或全身性栓塞的减少 （Ptrend=0.1）。结论在 ARTESiA 中，基线 SCAF 频率和最长发作持续时间与卒中或全身性栓塞的风险无关，并且不改变阿哌沙班对减少卒中或全身性栓塞的影响。注册网址：https://www.clinicaltrials.gov;唯一标识符：NCT01938248。