Department of Neurology, GHU Paris Psychiatrie et Neurosciences, Université de Paris, INSERM U1266, and FHU Neurovasc, Paris, France.
Division of Cardiology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea.
J Am Coll Cardiol. 2020 May 12;75(18):2312-2320. doi: 10.1016/j.jacc.2020.02.068.
In patients with patent foramen ovale (PFO)-associated stroke, the presence of large shunt or atrial septal aneurysm (ASA) has been suggested to convey a high risk of stroke recurrence.
The purpose of this study was to assess the respective influence of PFO size and ASA status on stroke recurrence under medical therapy in patients with recent PFO-associated stroke without alternative cause.
The authors pooled individual patient data from 2 prospective observational studies and the medical arms of 2 randomized trials, in which shunt size and ASA status was assessed by independent reading of echocardiographic images. Associations between PFO anatomical features and recurrent ischemic stroke were assessed by mixed effects Cox models.
Of 898 patients (mean age 45.3 years), 178 (19.8%) had ASA with large PFO, 71 (7.9%) ASA with nonlarge PFO, 397 (44.2%) large PFO without ASA, and 252 (28.1%) nonlarge PFO without ASA. Over a median follow-up of 3.8 years (interquartile range: 2.6 to 5.5 years), 47 (5.2%) patients experienced a recurrent stroke. There was a heterogeneity across studies for the association between PFO size and stroke recurrence (p = 0.01). In a model accounting for age, hypertension, antithrombotic therapy, and PFO anatomy, ASA was independently associated with recurrent stroke (adjusted hazard ratio: 3.27; 95% confidence interval: 1.82 to 5.86; p < 0.0001), whereas large PFO was not (average adjusted hazard ratio across studies: 1.43; 95% confidence interval: 0.50 to 4.03; p = 0.50).
In patients with PFO-associated stroke, ASA is a more important predictor of recurrent stroke than shunt size. These results can help to better identify those patients with a high risk of stroke recurrence under medical therapy who may derive the most benefit from PFO closure. (Patent Foramen Ovale Closure or Anticoagulants Versus Antiplatelet Therapy to Prevent Stroke Recurrence [CLOSE]; NCT00562289) (Device Closure versus Medical Therapy in Patients with Cryptogenic Stroke and High-Risk Patent Foramen Ovale [DEFENSE-PFO]; NCT01550588).
在卵圆孔未闭（PFO）相关卒中患者中，大分流或房间隔瘤（ASA）的存在提示卒中复发的风险较高。
本研究旨在评估 PFO 大小和 ASA 状态对无其他病因的近期 PFO 相关卒中患者接受药物治疗时卒中复发的各自影响。
作者汇集了 2 项前瞻性观察性研究和 2 项随机试验的药物治疗臂的个体患者数据，通过独立阅读超声心动图图像评估分流大小和 ASA 状态。采用混合效应 Cox 模型评估 PFO 解剖特征与复发性缺血性卒中之间的关联。
在 898 例患者（平均年龄 45.3 岁）中，178 例（19.8%）存在大 PFO 合并 ASA，71 例（7.9%）存在大 PFO 不合并 ASA，397 例（44.2%）存在小 PFO 合并 ASA，252 例（28.1%）存在小 PFO 不合并 ASA。在中位随访 3.8 年（四分位距：2.6 至 5.5 年）期间，47 例（5.2%）患者发生了复发性卒中。PFO 大小与卒中复发之间的关联在研究间存在异质性（p=0.01）。在考虑年龄、高血压、抗血栓治疗和 PFO 解剖的模型中，ASA 独立与复发性卒中相关（校正后的危险比：3.27；95%置信区间：1.82 至 5.86；p<0.0001），而大 PFO 则不然（各研究平均校正后的危险比：1.43；95%置信区间：0.50 至 4.03；p=0.50）。
在 PFO 相关卒中患者中，ASA 是卒中复发的比分流大小更重要的预测因素。这些结果可以帮助更好地识别那些在药物治疗下卒中复发风险较高的患者，这些患者可能从 PFO 封堵中获益最大。（卵圆孔未闭封堵或抗凝与抗血小板治疗预防卒中复发[CLOSE]；NCT00562289）（隐源性卒中和高危卵圆孔未闭患者的封堵装置与药物治疗[DEFENSE-PFO]；NCT01550588）。
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