Table 1

Summary of randomised studies on patent foramen ovale (PFO) closure for cryptogenic stroke (CS)

ClosureRespectPC trial
Inclusion18–60 years, PFO, CS or TIA within 6 months18–60 years, PFO, CS within 270 days<60 years, PFO, CS
Primary outcomeComposite: Stroke or TIA, death from any cause within 30 days, death from neurological causes between 31 days and 2 yearsRecurrence of non-fatal stroke, fatal ischaemic stroke or all-cause mortalityComposite: death from any cause, non-fatal stroke, TIA, peripheral embolism
Patients recruited909980414
Follow-up2 yearsMean 2.6 yearsMean 4 years
DeviceSTARFlexAmplatzer PFO OccluderAmplatzer PFO Occluder
Device closure effectiveness86%93.5%95.9
ClosureMedicalClosureMedicalClosureMedical
Dropouts15%19%10%19%16%20%
Kaplan-Meier ITT5.5%6.8%1.8%3.3%3.4%5.2%
HR0.78 (0.45 to 1.35)
p=0.37
0.49 (0.22 to 1.11)
p=0.08
0.63 (0.24 to 1.62)
p=0.34
Stroke ITT2.9%3.1%1.8%3.3%0.5%2.4%
HR0.90 (0.41 to 1.98)
p=0.79
0.53 (0.23 to 1.22)
p=0.16
0.20 (0.02 to 1.72)
p=0.14
As treatedNot presented1.0%3.3%Not presented
HR 0.27 (0.10 to 0.75)
p=0.01
 
  • ITT, intention-to-treat.