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Comparison of Patent Foramen Ovale Closure vs Medical Therapy for the Prevention of Recurrent Cryptogenic Stroke: A
Omar Hamodat1, Saif Almuzainy1, Rand Yahya1
1College of Medicine, University of Sharjah, Sharjah, United Arab Emirates.
Insights
Transcatheter device closure of patent foramen ovale (PFO) significantly reduces recurrent cryptogenic stroke and TIA compared to medical therapy. However, PFO closure increases atrial fibrillation risk, warranting further investigation.
Area of Science:
- Cardiology
- Neurology
- Interventional Cardiology
Background:
- Management of cryptogenic stroke with patent foramen ovale (PFO) is debated.
- Optimal strategy involves medical therapy versus transcatheter device closure.
- This review provides updated insights on recurrent stroke prevention.
Purpose of the Study:
- To systematically review and compare the effectiveness of PFO closure versus medical therapy for preventing recurrent cryptogenic stroke.
- To incorporate recent randomized controlled trials (RCTs) into the analysis.
Main Methods:
- Systematic search of PubMed, Scopus, and Ovid databases up to December 2024.
- Inclusion of RCTs comparing PFO closure with medical therapy in cryptogenic stroke patients.
- Analysis of 7 RCTs with 4539 participants.
Main Results:
- PFO closure significantly reduced stroke and transient ischemic attack (TIA) incidence compared to medical therapy.
- No stroke events occurred in PFO closure groups in the CLOSE and DEFENSE-PFO trials.
- All-cause mortality was similar; PFO closure increased atrial fibrillation risk.
Conclusions:
- PFO closure is superior to medical therapy for preventing recurrent cryptogenic stroke and TIA.
- Increased atrial fibrillation post-PFO closure requires further research.
- Identifying patient subsets benefiting from anticoagulation is crucial.
Objectives:
The optimal management approach for patients with cryptogenic stroke and patent foramen ovale (PFO) remains uncertain. Whether medical therapy-using antiplatelet agents or anticoagulants-or transcatheter device closure offers superior protection against stroke recurrence has been a topic of considerable debate. This systematic review aims to assess and compare the effectiveness of these two treatment strategies, incorporating recent studies to provide updated insights on the most effective approach to preventing recurrent cryptogenic stroke.
Methodology:
We systematically searched PubMed, Scopus, and Ovid database through December 2024. Eligible studies were randomized controlled clinical trials (RCTs) comparing PFO closure versus medical therapy among patients with cryptogenic stroke.
Results:
This systematic review analyzed 7 RCTs encompassing 4539 patients with a mean age of 43.6 years, 53.38 % of whom were male. Patient characteristics, including comorbidities such as hypertension, hyperlipidemia, and diabetes mellitus, were well-balanced across groups receiving PFO closure or medical therapy. The primary analysis revealed a significant reduction in stroke incidence with PFO closure compared to medical therapy, with no stroke events in the PFO closure groups of the CLOSE and DEFENSE-PFO trials. Similarly, transient ischemic attack (TIA) incidence was consistently lower in PFO closure groups. All-cause mortality was comparable between groups, underscoring the safety profile of PFO closure. However, PFO closure was associated with a higher incidence of atrial fibrillation. Major bleeding risks varied, reflecting the need for tailored risk assessment.
Conclusion:
PFO closure offers a significant advantage over medical therapy in preventing recurrent cryptogenic stroke and TIA. Nevertheless, the observed increase in atrial fibrillation postclosure highlights the need for additional research to elucidate its long-term implications and to determine whether anticoagulation could benefit specific subsets of patients with PFO and a history of stroke.
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