Hammad Amer, Ahmad Abdullah, Khraisat Own, Kumar Vicky, Munshi Hasan, Khalid Noman, Al Rayess Nasr, Ashkar Hamdallah, Muhammad Haris, Challita Ronald, Bikkina Mahesh, Shamoon Fayez, Sommer Robert, Vasudev Rahul
Department of Internal Medicine, Englewood Hospital Medical Center, Englewood, NJ 07631, USA.
Department of Cardiology, St. Joseph's University Medical Center, Paterson, NJ 07503, USA.
Cardiovasc Revasc Med. 2025 Jul 2. doi: 10.1016/j.carrev.2025.06.037.
Percutaneous Patent Foramen Ovale (PFO) closure reduces recurrent ischemic stroke and transient ischemic attack (TIA) in cryptogenic stroke patients. The publication of additional studies and the inclusion of a larger patient population necessitate an updated analysis to evaluate its efficacy and safety compared to medical therapies and across different age groups.
To compare the efficacy and safety of PFO closure versus medical therapy for the secondary prevention of stroke and TIA.
A systematic literature search was performed using PubMed, CENTRAL, and EMBASE from inception to August 2024.
Included studies involved adults (≥18) with ischemic neurological events and confirmed PFO, comparing percutaneous PFO closure to medical therapy, and reporting outcomes of interest.
Data were independently extracted by 2 reviewers following PRISMA guidelines. Quality assessment utilized the Cochrane Risk of Bias tool for RCTs and the Newcastle-Ottawa Scale for observational studies. Odds ratios (ORs) with 95 % confidence intervals (CIs) were pooled using random or fixed effects models. Subgroup analyses were conducted based on age, shunt size, and presence of ASA.
MAIN OUTCOME(S) AND MEASURE(S): Primary outcomes included recurrent ischemic stroke and/or TIA, and all-cause mortality. The safety outcomes were atrial fibrillation/flutter and major bleeding.
A total of 32 studies (6 randomized controlled trials and 26 observational studies) comprising 16,698 patients met the inclusion criteria. PFO closure significantly reduced the risk of recurrent ischemic stroke/TIA compared to medical therapy (OR 0.52, P < 0.001), with greater benefits over antiplatelet therapy (OR 0.33, P < 0.001) and anticoagulant therapy (OR 0.42, P < 0.001). Additionally, PFO closure reduced all-cause mortality (OR 0.49, P < 0.001) but was associated with an increased risk of atrial fibrillation (OR 3.45, P < 0.001). Subgroup analyses demonstrated similar significant benefits in recurrent stroke prevention for both older patients (≥60 years, OR 0.39) and younger patients (<60 years, OR 0.56).
This meta-analysis suggests that PFO closure is associated with lower risk of recurrent ischemic events and all-cause mortality compared to medical therapy. However, outcomes such as TIA and mortality were predominantly observed in observational studies. These findings are hypothesis-generating and support further investigation in selected patient populations.
经皮卵圆孔未闭（PFO）封堵术可降低不明原因卒中患者复发性缺血性卒中和短暂性脑缺血发作（TIA）的风险。随着更多研究的发表以及纳入了更广泛的患者群体，有必要进行更新分析，以评估与药物治疗相比以及在不同年龄组中的疗效和安全性。
比较PFO封堵术与药物治疗在卒中及TIA二级预防中的疗效和安全性。
使用PubMed、CENTRAL和EMBASE进行了从起始到2024年8月的系统文献检索。
纳入的研究涉及成年（≥18岁）缺血性神经事件患者且确诊为PFO，比较经皮PFO封堵术与药物治疗，并报告感兴趣的结局。
两名审阅者按照PRISMA指南独立提取数据。质量评估采用Cochrane随机对照试验偏倚风险工具和观察性研究的纽卡斯尔-渥太华量表。使用随机或固定效应模型汇总95%置信区间（CI）的比值比（OR）。根据年龄、分流大小和是否存在抗磷脂抗体综合征进行亚组分析。
主要结局包括复发性缺血性卒中和/或TIA以及全因死亡率。安全性结局为心房颤动/扑动和大出血。
共有32项研究（6项随机对照试验和26项观察性研究），涉及16,698例患者，符合纳入标准。与药物治疗相比，PFO封堵术显著降低了复发性缺血性卒中和/或TIA的风险（OR 0.52，P < 0.001），与抗血小板治疗相比获益更大（OR 0.33，P < 0.001），与抗凝治疗相比（OR 0.42，P < 0.001）。此外，PFO封堵术降低了全因死亡率（OR 0.49，P < 0.001），但与心房颤动风险增加相关（OR 3.45，P < 0.001）。亚组分析表明，在预防复发性卒中方面，老年患者（≥60岁，OR 0.39）和年轻患者（<60岁，OR 0.56）均有类似的显著获益。
该荟萃分析表明，与药物治疗相比，PFO封堵术与复发性缺血事件和全因死亡率风险较低相关。然而，TIA和死亡率等结局主要在观察性研究中观察到。这些发现具有启发性，支持在特定患者群体中进行进一步研究。
