Table 1.
Clinical trials on PFO closure versus medical therapy to prevent recurrent cryptogenic stroke
| Study (acronym) | Number of patients | Follow-up (months) | Lost to F/U | Intervention group | Medical therapy group | Conclusions |
|---|---|---|---|---|---|---|
| CLOSURE I[11] | 909 | 44 (2003-2008) | Intervention group 5% (24/447) Medical group 17% (77/462) |
Starflex + aspirin (2 years) and clopidogrel (6 months) | Aspirin, coumadin or aspirin, coumadin (at the physician’s discretion) | No difference between PFO percutaneous closure and medical therapy |
| PC TRIAL[12] | 414 | 49 (2000-2009) | Intervention group 12% (24/204) Medical group 15% (31/210) |
Amplatzer + aspirin (5-6 months) and ticlopidine or clopidogrel | Antiplatelet or/and coumadin (at the physician’s discretion) | No reduction in the risk of recurrent embolic events or death |
| RESPECT[13] | 980 | 31 (2003-2011) | Intervention group 9.2% (46/499) Medical group 17.2% (83/481) |
Amplatzer + aspirin and clopidogrel for 1-month followed by aspirin for 5 months | Aspirin 46.5%, coumadin 25.2% Clopidogrel 14% aspirin + dipyridamole 8.1% aspirin + clopidogrel 6.2% |
No benefit for recurrent stroke prevention |
PFO = Patent foramen ovale