Table 1.
Results of clinical trials of PFO closure
| CLOSURE I (2012) [40] (n = 909) | RESPECT (2013) [41] (n = 980) | PC (2013) [42] (n = 414) | |
|---|---|---|---|
| Inclusion | Stroke or TIA | Stroke or TIA, peripheral TE | Stroke or TIA, peripheral TE |
| Groups | |||
| 1. Closure device | STARFlex | Amplatzer | Amplatzer |
| 2. Medical arm | Aspirin, warfarin | Aspirin, clopidogrel, aggrenox, warfarin | Aspirin, ticlopidine, clopidogrel, warfarin |
| Outcome | 2 years | 8 years | 4 years |
| Death, stroke or TIA | Death, stroke or TIA, peripheral TE | Death, stroke or TIA, peripheral TE | |
| Primary end point, HR (95% CI) | 0.78 (0.45-1.35) | 0.63 (0.24-1.62) | 0.63 (0.24-1.62) |
| (medical vs. closure arm) | (M 5.5% vs. C 6.8%) | (M 5.2% vs. C 3.4%) | (M 3.4% vs. C 5.2%) |
| Stroke or TIA, HR (95% CI) | 0.82 (0.38-1.76) | 0.49 (0.22-1.11) | 0.45 (0.16-1.29) |
| (medical vs. closure arm) | (M 2.4% vs. C 0.6%) | (M 3.3% vs. C 1.9%) | (M 5.2% vs. C 3.4%) |
| New-onset AF, OR (95% CI) | 9.11 (2.71-30.58)* | 1.93 (0.17-21.37) | 3.15 (0.63-15.80) |
| (medical vs. closure arm) | (M 0.7% vs. C 5.8%) | (M 1.5% vs. C 3.1%) | (M 1.0% vs. C 3.0%) |
*
P<0.05.
TIA, transient ischemic attack; TE, thromboembolism; M, medical arm; C, closure arm; HR, hazard ratio; OR, odds ratio; CI, confidence interval; AF, atrial fibrillation.