Table 1

Characteristics of patients in eligible studies

Authorn randomisedMean age% MaleInclusion criteriaModerate or higher shunt (%)*Atrial septal aneurysm>10 mm (%)†Most common device used for closure
PFO closure plus antiplatelet vs antiplatelet therapy
 Furlan (CLOSURE 1, 2012)90946.051.8Cryptogenic stroke, PFO, >18 years and <60 years52.9‡37.8STARFlex 100%
 Mas (CLOSE, 2017)47343.459.0Cryptogenic stroke, PFO, >16 years and <60 years92.5§31.8Amplatzer 52%¶
 Meier (PC Trial, 2013)41444.549.8Cryptogenic stroke, PFO, >18 years and <60 years65.6**23.7¶¶Amplatzer 100%
 Saver (RESPECT, 2017)98045.954.7Cryptogenic stroke, PFO, >18 years and <60 years48.8††35.7***Amplatzer 100%
 Sondergaard (REDUCE, 2017)66445.160.6Cryptogenic stroke, PFO, >18 years and <60 years81.0‡NR for AP groupCardioform 61%‡‡
 Lee (DEFENCE PFO, 2018)12051.555.8Cryptogenic stroke, PFO, no age limitNA10.8Amplatzer 100%
PFO closure plus antiplatelet vs anticoagulation
 Mas (CLOSE, 2017)353NANACryptogenic stroke, PFO, >16 years and <60 yearsNANANA
Anticoagulation vs antiplatelet therapy
 Homma (PICSS, 2002)203 (98 with
57.959.1PFO with or without cryptogenic stroke
>30 years and <85 years
 Mas (CLOSE, 2017)36144.257.0Cryptogenic stroke, PFO, >16 years and <60 yearsNANANA
 Shariat34 4461.463.6Cryptogenic stroke, PFO, >18 yearsNANANA
  • *Shunt size was measured based on the number of microbubbles in the left atrium within three cycles of being seen in the right atrium on transthoracic or transoesophageal echocardiography.

  • †Atrial septal aneurysm was assessed on transoesophageal echo and was defined as septal mobility or protrusion.

  • ‡Greater than or equal to 25 microbubbles.

  • §Greater than or equal to 30 microbubbles.

  • ¶ 13% Intrasept PFO occluder, 9% STARFlex septal closure system, 9% Premere, 6% Amplatzer cribriform occluder, 6% Figulla flex II PFO occluder, 1% Atriasept II occluder, 1% Gore helex septal occluder, 1% Amplatzer AS occluder, 1% Figulla flex II UNI occluder, 1% Figulla flex II ASD occluder.

  • **Greater than or equal to 20 microbubbles.

  • ††Size of shunt not clearly defined.

  • ‡‡39% Gore helex septal occluder.

  • §§At least one microbubble.

  • ¶¶Atrial septal aneurysm >15 mm.

  • ***Atrial septal aneurysm not clearly defined.

  • NA, not available; PFO, patent foramen ovale.