Closure | Respect | PC trial | |
---|---|---|---|
Inclusion | 18–60 years, PFO, CS or TIA within 6 months | 18–60 years, PFO, CS within 270 days | <60 years, PFO, CS |
Primary outcome | Composite: Stroke or TIA, death from any cause within 30 days, death from neurological causes between 31 days and 2 years | Recurrence of non-fatal stroke, fatal ischaemic stroke or all-cause mortality | Composite: death from any cause, non-fatal stroke, TIA, peripheral embolism |
Patients recruited | 909 | 980 | 414 |
Follow-up | 2 years | Mean 2.6 years | Mean 4 years |
Device | STARFlex | Amplatzer PFO Occluder | Amplatzer PFO Occluder |
Device closure effectiveness | 86% | 93.5% | 95.9 |
Closure | Medical | Closure | Medical | Closure | Medical | |
---|---|---|---|---|---|---|
Dropouts | 15% | 19% | 10% | 19% | 16% | 20% |
Kaplan-Meier ITT | 5.5% | 6.8% | 1.8% | 3.3% | 3.4% | 5.2% |
HR | 0.78 (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 ITT | 2.9% | 3.1% | 1.8% | 3.3% | 0.5% | 2.4% |
HR | 0.90 (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 treated | Not presented | 1.0% | 3.3% | Not presented | ||
HR | 0.27 (0.10 to 0.75) p=0.01 |
ITT, intention-to-treat.