1 Department of Neurology, Sainte-Anne Hospital, INSERM 894, DHU NeuroVasc Sorbonne Paris-Cité, Paris Descartes University, Paris, France.
2 Epidemiology and Clinical Research Unit, Georges Pompidou European Hospital, AP-HP, INSERM CIC 1418, Paris Descartes University, Paris, France.
Int J Stroke. 2018 Apr;13(3):240-242. doi: 10.1177/1747493017751243. Epub 2018 Jan 4.
Contrasting with three randomized trials that failed to show any superiority of patent foramen ovale closure over antithrombotic therapy, two trials recently reported lower rates of stroke recurrence among patients assigned to patent foramen ovale closure than among those assigned to antiplatelet therapy. In addition, one of the initially negative trials concluded in favor of patent foramen ovale closure after an extended follow-up period. A better selection of patients, the use of reference treatment groups that included patients who received antiplatelet therapy alone (rather than antiplatelet drugs or oral anticoagulants, according to physician preference), and a longer follow-up of patients, may explain the divergent findings across studies. Procedural complications were reported in 1.5% to 5.9% of the patients, none of which led to permanent disability or death. Patent foramen ovale closure was associated with an increased risk of new-onset atrial fibrillation in several studies and of venous thromboembolism in one study.
与三项未能显示卵圆孔未闭封堵术优于抗血栓治疗的随机试验相反,最近两项试验报告称,与接受抗血小板治疗的患者相比,接受卵圆孔未闭封堵术的患者卒中复发率较低。此外,最初一项阴性试验在延长随访期后得出了支持卵圆孔未闭封堵术的结论。更好的患者选择、使用包括仅接受抗血小板治疗的患者的参考治疗组(而不是根据医生偏好选择抗血小板药物或口服抗凝剂)以及更长时间的患者随访可能解释了不同研究之间的差异发现。在 1.5%至 5.9%的患者中报告了手术并发症,无一例导致永久性残疾或死亡。在几项研究中,卵圆孔未闭封堵术与新发心房颤动风险增加相关,而在一项研究中与静脉血栓栓塞风险增加相关。