Windecker Stephan, Wahl Andreas, Nedeltchev Krassen, Arnold Marcel, Schwerzmann Markus, Seiler Christian, Mattle Heinrich P, Meier Bernhard
Department of Cardiology, University Hospital, Bern, Switzerland.
J Am Coll Cardiol. 2004 Aug 18;44(4):750-8. doi: 10.1016/j.jacc.2004.05.044.
The purpose of this study was to compare the efficacy of medical treatment with percutaneous closure of patent foramen ovale (PFO).
Patients with cryptogenic stroke and PFO are at risk for recurrent cerebrovascular events.
We compared the risk of recurrence in 308 patients with cryptogenic stroke and PFO, who were treated either medically (158 patients) or underwent percutaneous PFO closure (150 patients) between 1994 and 2000.
Patients undergoing percutaneous PFO closure had a larger right-to-left shunt (p < 0.001; 95% confidence interval [CI] 1.38 to 3.07) and were more likely to have suffered more than one cerebrovascular event (p = 0.03; 95% CI 1.04 to 2.71). At four years of follow-up, percutaneous PFO closure resulted in a non-significant trend toward risk reduction of death, stroke, or transient ischemic attack (TIA) combined (8.5% vs. 24.3%; p = 0.05; 95% CI 0.23 to 1.01), and of recurrent stroke or TIA (7.8% vs. 22.2%; p = 0.08; 95% CI 0.23 to 1.11) compared with medical treatment. Patients with more than one cerebrovascular event at baseline and those with complete occlusion of PFO were at lower risk for recurrent stroke or TIA after percutaneous PFO closure compared with medically treated patients (7.3% vs. 33.2%; p = 0.01; 95% CI 0.08 to 0.81, and 6.5% vs. 22.2%; p = 0.04; 95% CI 0.14 to 0.99, respectively).
Percutaneous PFO closure appears at least as effective as medical treatment for prevention of recurrent cerebrovascular events in cryptogenic stroke patients with PFO. It might be more effective than medical treatment in patients with complete closure and more than one cerebrovascular event.
本研究旨在比较药物治疗与经皮闭合卵圆孔未闭（PFO）的疗效。
隐源性卒中合并PFO的患者有复发性脑血管事件的风险。
我们比较了1994年至2000年间308例隐源性卒中合并PFO患者的复发风险，这些患者分别接受了药物治疗（158例）或经皮PFO闭合治疗（150例）。
接受经皮PFO闭合治疗的患者有更大的右向左分流（p<0.001；95%置信区间[CI]1.38至3.07），并且更有可能发生过不止一次脑血管事件（p=0.03；95%CI 1.04至2.71）。在四年的随访中，与药物治疗相比，经皮PFO闭合治疗在降低死亡、卒中或短暂性脑缺血发作（TIA）联合发生的风险方面有不显著的趋势（8.5%对24.3%；p=0.05；95%CI 0.23至1.01），以及复发性卒中或TIA的风险方面（7.8%对22.2%；p=0.08；95%CI 0.23至1.11）。与药物治疗的患者相比，基线时有不止一次脑血管事件的患者以及PFO完全闭合的患者在经皮PFO闭合治疗后发生复发性卒中或TIA的风险较低（分别为7.3%对33.2%；p=0.01；95%CI 0.08至0.81，以及6.5%对22.2%；p=0.04；95%CI 0.14至0.99）。
对于预防合并PFO的隐源性卒中患者的复发性脑血管事件，经皮PFO闭合治疗似乎至少与药物治疗一样有效。对于PFO完全闭合且有不止一次脑血管事件的患者，它可能比药物治疗更有效。
