Data from: Patent foramen ovale closure, antiplatelet therapy or anticoagulation in patients with patent foramen ovale and cryptogenic stroke: a systematic review and network meta-analysis incorporating complementary external evidence

Objective: To examine the relative impact of three management options in
patients less than 60 years old with cryptogenic stroke and a patent
foramen ovale (PFO): PFO closure plus antiplatelet therapy, antiplatelet
therapy alone, and anticoagulation alone. Design: Systematic review and
network meta-analysis (NMA) supported by complementary external evidence
Data sources: Medline, EMBASE, and Cochrane CENTRAL. Study selection:
Randomised controlled trials (RCTs) addressing PFO closure and/or medical
therapies in patients with PFO and cryptogenic stroke. Review methods: We
conducted an NMA complemented with external evidence and rated certainty
of evidence using the GRADE system. Results: Ten RCTs in eight studies
proved eligible (n=4416). PFO closure versus antiplatelet therapy probably
results in substantial reduction in ischaemic stroke recurrence (risk
difference per 1000 patients over 5 years [RD]: -87, 95% credible interval
[CrI] -100 to -33; moderate certainty). Compared with anticoagulation, PFO
closure may confer little or no difference in ischaemic stroke recurrence
(low certainty) but probably has a lower risk of major bleeding (RD -20,
95% Crl -27 to -2, moderate certainty). Relative to either medical
therapy, PFO closure probably increases the risk of persistent atrial
fibrillation (RD 18, CI +5 to +56, moderate certainty) and device-related
adverse events (RD +36, 95% CI +23 to +50, high certainty).
Anticoagulation, compared to antiplatelet therapy, may reduce the risk of
ischaemic stroke recurrence (RD -71, 95% CrI -100 to +17, low certainty),
but probably increases the risk of major bleeding (RD +12, CrI -5 to +65,
moderate certainty). Conclusions: In patients less than 60 years old, PFO
closure probably confers an important reduction in ischaemic stroke
recurrence compared to antiplatelet therapy alone but may make no
difference compared to anticoagulation. PFO closure incurs a risk of
persistent atrial fibrillation and device-related adverse events. Compared
to alternatives, anticoagulation probably increases major bleeding.

研究目标：探讨三种管理方案对60岁以下隐源性卒中（cryptogenic stroke）合并卵圆孔未闭（patent foramen ovale, PFO）患者的相对影响：卵圆孔未闭封堵联合抗血小板治疗、单纯抗血小板治疗、单纯抗凝治疗。
研究设计：辅以补充外部证据的系统评价与网状meta分析（network meta-analysis, NMA）。
数据来源：Medline、EMBASE及Cochrane CENTRAL数据库。
研究筛选：纳入针对卵圆孔未闭合并隐源性卒中患者，探讨卵圆孔未闭封堵和/或药物治疗的随机对照试验（randomised controlled trials, RCTs）。
评价方法：本研究开展辅以外部证据的网状meta分析，并采用GRADE系统对证据确定性进行评级。
研究结果：共纳入8项研究中的10项符合标准的随机对照试验，合计4416例受试者。与单纯抗血小板治疗相比，卵圆孔未闭封堵可显著降低缺血性卒中复发风险（5年时每1000例患者的风险差[risk difference, RD]：-87，95%可信区间[credible interval, CrI]：-100~-33；中等确定性）。与抗凝治疗相比，卵圆孔未闭封堵对缺血性卒中复发的影响可能无显著差异（低确定性），但可降低大出血风险（RD -20，95% CrI：-27~-2；中等确定性）。相较于任一药物治疗方案，卵圆孔未闭封堵会增加持续性心房颤动的风险（RD 18，95% CI：+5~+56；中等确定性）及装置相关不良事件的风险（RD +36，95% CI：+23~+50；高确定性）。与单纯抗血小板治疗相比，抗凝治疗可能降低缺血性卒中复发风险（RD -71，95% CrI：-100~+17；低确定性），但可能增加大出血风险（RD +12，95% CrI：-5~+65；中等确定性）。
研究结论：对于60岁以下患者，与单纯抗血小板治疗相比，卵圆孔未闭封堵可显著降低缺血性卒中复发风险（中等确定性），但与抗凝治疗相比无显著差异。卵圆孔未闭封堵存在持续性心房颤动及装置相关不良事件的风险。与其他治疗方案相比，抗凝治疗可能增加大出血风险。