Meta-analysis: Value of PFO Closure vs Medical Therapy Varies by Device

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Whether or not percutaneous closure of patent foramen ovale (PFO) can benefit patients with cryptogenic embolism more than medical therapy depends on the device used, asserts a paper published online August 11, 2014, ahead of print in the European Heart Journal. 

Compared with those allocated to medical therapy, patients randomly assigned to closure using the Amplatzer device were less likely to experience stroke. CardioSEAL/STARFlex carried no added benefit over medical therapy, and investigators described the results for Helex as “inconclusive due to wide confidence intervals” (table 1).

Table 1. Likelihood of Stroke vs Medical Therapy

The probability of being best at stroke prevention was:

• 77.1% for Amplatzer
• 20.9% for Helex
• 1.7% for CardioSEAL/STARFlex
• 0.4% for medical therapy 

Though there were no significant differences related to TIA or death, the risk of new-onset A-fib compared with medical therapy was most pronounced for the CardioSEAL/STARFlex, though also significant with Amplatzer (table 2). 

Table 2. Likelihood of New-Onset A-fib vs Medical Therapy

The number needed to treat to prevent 1 stroke over 5 years was 29 for Amplatzer, and the number needed to harm to cause 1 case of A-fib was 7 for CardioSEAL/STARFlex and 43 for Amplatzer.

A-fib Merits Attention  

In addition to demonstrating the superiority of Amplatzer for stroke prevention, the study results also “suggest the necessity of closely monitoring the cardiac rhythm of treated patients, and appropriate management in case of documented atrial fibrillation,” the researchers say, noting that clinicians should select patients for closure using eligibility criteria of the aforementioned trials. 

“To further improve clinical outcomes after PFO closure, future devices should be designed to minimize thrombogenicity and the risk of atrial fibrillation while ensuring high rates of effective closure,” they add. 

Dr. Jüni and colleagues cite 3 ongoing randomized trials of PFO closure:

• DEFENSE-PRO: Amplatzer vs medical therapy
• Gore REDUCE: Helex vs medical therapy
• CLOSE: various devices vs antiplatelet therapy vs anticoagulant therapy

“The results of our network meta-analysis indicate that the mix of devices will make the interpretation of the results difficult, unless the set-up of the trial allows stratification by type of device,” they point out.

Source: 
Stortecky S, da Costa BR, Mattle HP, et al. Percutaneous closure of patent foramen ovale in patients with cryptogenic embolism: a network meta-analysis. Eur Heart J. 2014;Epub ahead of print.

Disclosures: 
Dr. Jüni reports serving as an investigator for the PC Trial, funded by St. Jude Medical, and as an unpaid steering committee or statistical executive committee member of trials funded by Abbott Vascular, Biosensors, Johnson & Johnson, and Medtronic.

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