Patent Foramen Ovale Closure in the Setting of Cryptogenic Stroke: A Meta-Analysis of Five Randomized Trials

Area of Science:

• Cardiology
• Neurology
• Interventional Cardiology

Background:

• The clinical benefit of patent foramen ovale (PFO) closure for cryptogenic stroke prevention remains debated.
• Recent randomized trials suggest PFO closure reduces recurrent stroke risk compared to medical therapy alone.
• This meta-analysis aims to clarify PFO closure's efficacy in preventing future strokes.

Purpose of the Study:

• To evaluate the effectiveness of patent foramen ovale (PFO) closure in preventing recurrent strokes.
• To synthesize data from multiple randomized clinical trials on PFO closure outcomes.
• To determine the impact of PFO closure on stroke recurrence rates in cryptogenic stroke patients.

Main Methods:

• Systematic literature search and meta-analysis of 5 large randomized clinical trials (CLOSE, RESPECT, Gore REDUCE, CLOSURE I, PC).
• Pooled data analysis of 3412 patients with cryptogenic stroke, comparing endovascular PFO closure with standard medical care.
• Primary outcome: reduction in stroke recurrence rate; secondary outcomes: TIA, composite outcomes, and atrial fibrillation events.

Main Results:

• Transcatheter PFO closure significantly reduced recurrent stroke rates compared to medication alone.
• Patients undergoing PFO closure had a 58% lower likelihood of experiencing another stroke.
• The number needed to treat (NNT) with PFO closure to prevent one recurrent stroke was 40.

Conclusions:

• Endovascular PFO closure is associated with a reduced risk of recurrent stroke in patients with prior cryptogenic cerebral infarct.
• Despite a small absolute stroke reduction, the findings are clinically significant due to the young age and lifetime risk of the patient population.
• PFO closure represents a clinically significant intervention for stroke prevention in select patients.