Table 1 Design and baseline data from the six randomised studies on PFO closure in cryptogenic stroke [9, 11, 23]
From: Cryptogenic stroke and patent foramen ovale (abridged and translated version)
Parameters | Closure I | PC Trial | RESPECTa | REDUCE | CLOSE | Defense PFO |
|---|---|---|---|---|---|---|
Patients (n) | 909 | 414 | 980 | 664 | 663 | 120 |
Mean age | 46 | 44.5 | 46 | 42.2 | 43.3 | 51.8 |
RLS (%) | 53 | 65.6 | 48.8 | 81.3 | 100 | 53 |
ASA (%) | 36.6 | 23.7 | 35.7 | 20.6 | 32.8 | 10 |
ATH | ASA, OAC | APT, OAC | APT, OAC | APT | APT, OAC | APT |
OAC (%) | 34 | 31 | 25 | 0 | 28 | 0 |
Device | STARFlex | Amplatzer PFO | Amplatzer PFO | Cardioform Helex | no specification | Amplatzer |
Endpoint | Stroke, TIA, death | Death, stroke, TIA, embolism | Stroke, early death | Stroke | Stroke | Stroke, vascular death, TIMI bleeding |
Follow-up (months) | 44 | 49 | 70.8 | 38.4 | 63.6 | 24 |