PFO封堵治疗对不同再发脑卒中危险积分的PFO合并CS患者的疗效

Therapeutic effect of patent foramen ovale closure on PFO+CS patients with different risk scores of recurrent stroke

目的:研究卵圆孔未闭(PFO)封堵对不同再发脑卒中(RS)危险积分的PFO合并隐原性(原发性)脑卒中(CS)患者的疗效.方法:于我院治疗的559例PFO合并CS患者被随机分为药物治疗组(282例,接受常规药物治疗)和封堵治疗组(277例,接受PFO封堵治疗后使用阿司匹林6个月联合氯吡格雷3个月),两组均随访15个月~6年.观察比较两组基本临床资料及随访期间RS发生率、不良事件发生率.结果:随访期间,封堵治疗组RS发生率显著低于药物治疗组(1.1%比4.3%,P=0.020);当危险积分为0~1分时,两组RS发生率无显著性差异(P=0.983);当危险积分为2~6分时,封堵治疗组RS发生率显著低于药物治疗组(0.0%比8.1%,P=0.001).治疗1个月内,两组阵发性房颤发生率无显著差异(P=0.981),封堵治疗组严重出血发生率显著低于药物治疗组(0.0%比3.2%,P=0.008).结论:PFO封堵治疗能显著降低再发脑卒中危险积分2~6分的PFO合并CS患者的再发脑卒中发生率,且能显著减低严重出血发生率.

Objective:To study therapeutic effect of patent foramen ovale(PFO) closure on PFO patients complicated cryptogenic(namely primary) stroke(CS) with different risk scores of recurrent stroke(RS). Methods:A total of 559 PFO+CS patients were randomly divided into medication group(n=282, received routine medication) and closure treatment group(n=277, received aspirin for six months combined clopidogrel for three months after PFO closure treatment). Both groups were followed up for 15 months to six years. Baseline clinical data and incidence rates of RS and adverse events during 12-month follow-up were observed and compared between two groups. Results:During follow-up, incidence rate of RS in closure treatment group was significantly lower than that of medication group(1.1% vs. 4.3%, P=0.020). When the risk score was 0~1 score, there was no significant difference in incidence rate of RS between two groups(P=0.983);when the risk score was 2~6 scores, incidence rate of RS in closure treatment group was significantly lower than that of medication group(0.0% vs. 8.1%, P=0.001).Within one month after trenamout, there was no significant difference in incidence rate of paroxysmal atrial fibrillation between two groups(P=0.981), and incidence rate of severe bleeding in closure treatment group was significantly lower than that of medication group(0.0% vs. 3.2%, P=0.008). Conclusion:PFO closure treatment can significantly reduce incidence rate of recurrent stroke in PFO+CS patients with 2~6 risk scores of recurrent stroke and it can significantly reduce incidence rate of severe bleeding.