It appears that finally there is some sunlight coming over the horizon for PFO suffers in the USA with FDA advisors giving a green light to PFO closure for stroke with the Amplatz PFO Occluder. Click on the link above to go the the TCDMD article.
RESPECT – Stroke and PFO Trial 10 yr results released
Results of the 10 year extended follow up for the RESPECT trial were released in San Francisco in October 2015. The trial is the largest randomised PFO trial in history with the longest follow up now reaching 10 years (5 yr mean), involving 980 patients to evaluate secondary stroke prevention.
What patients were involved?
- Patients with a PFO who have a cryptogenic stroke (stroke of unknown cause) in the last 270 days.
- Patients were randomised in to receiving the Amplatzer PFO Occluder (n=499) or receiving structured medical management (n=481)
Who was excluded?
- Patients aged <18 years or >60 years
- Patients with identified stroke cause
- Patients who were unable to discontinue anticoagulants (PFO closure patients had to cease Aspirin and other anticoagulants after 3 months)
Compared to the medical management at 10 year follow up (5 year mean) there was a:
- 75% relative risk reduction in patients with significant PFO’s or atrial septal aneurysm (p=0.007)
- 70% relative risk reduction in patients having PFO closure (p=0.004)
- 52% relative risk reduction for all causes of stroke (p=0.035)
- The procedure is safe with no major procedural complications
- Major vascular complication (0.9%), device explant (0.4%)
11% of patients assigned to the medical management arm left the trial due to having off-label PFO closure. This means stroke patients actively sort PFO closure elsewhere when they discovered they did not get the PFO closure procedure.
- Safe and highly effective procedure for stroke prevention in young patients with large PFO
- Stroke and recurrent stroke is a life long accumulative risk. Published rates of stroke in patients with untreated PFO range between 1-2% per year.
RESPECT – Stroke Comparing PFO Closure to Established Current Standard of Care Treatment