Department of Cardiology, Maastricht University Medical Center, , Maastricht, The Netherlands.
Heart. 2014 Apr;100(7):563-8. doi: 10.1136/heartjnl-2013-305017. Epub 2014 Jan 31.
Current stroke risk schemes need improvement of predictive value in patients with atrial fibrillation. Transoesophageal echocardiography (TEE) may facilitate stroke risk assessment in such patients and guide antithrombotic treatment.
We randomised 238 patients with non-valvular atrial fibrillation and a moderate stroke risk to aspirin or adjusted vitamin K antagonist therapy after TEE had ruled out thrombogenic features in the atria and aorta. The primary outcome was a composite of stroke, major bleeding, peripheral embolism and all-cause mortality.
Mean CHA2DS2-VASc score was 2.1±1.1. The incidences of the composite primary outcome at a mean follow-up of 1.6 years were 3.2% (2.02% per year) in the aspirin group compared to 6.1% (3.84% per year) in the vitamin K antagonists group with an absolute advantage of 2.9 percentage points. Aspirin was non-inferior to vitamin K antagonists (p<0.0001) because the upper limit of the 90% CI did not exceed the 7% absolute difference in event rate between the two treatment arms.
This hypothesis-generating pilot trial has found that TEE may be used for refinement of stroke risk in paroxysmal atrial fibrillation patients. A larger trial is needed to confirm these data. (ClinicalTrials.gov number NTC00224757).
目前的中风风险评估方案需要提高在房颤患者中的预测价值。经食管超声心动图（TEE）可以帮助评估此类患者的中风风险并指导抗血栓治疗。
我们将 238 例非瓣膜性房颤且中风风险中度的患者随机分为阿司匹林组或调整后的维生素 K 拮抗剂治疗组，TEE 排除了心房和主动脉的血栓形成特征。主要终点是中风、大出血、外周栓塞和全因死亡率的复合终点。
平均 CHA2DS2-VASc 评分为 2.1±1.1。平均 1.6 年的随访中，阿司匹林组的复合主要终点发生率为 3.2%（每年 2.02%），而维生素 K 拮抗剂组为 6.1%（每年 3.84%），绝对优势为 2.9 个百分点。阿司匹林与维生素 K 拮抗剂无差异（p<0.0001），因为置信区间的上限未超过两个治疗组之间 7%的绝对事件发生率差异。
这项探索性试验发现，TEE 可用于改善阵发性房颤患者的中风风险评估。需要更大规模的试验来证实这些数据。（临床试验编号 NTC00224757）。
