Table 4. Outcomes after PFOC and antithrombotic treatment regimen.
| EC, <9 months(N=301) | DC, ≥9 months(N=162) | P value | |
| Follow-up duration (years) | 2.0 (1.3–3.8) | 2.2 (1.2–4.9) | 0.721 |
| One-year post procedure follow-up | |||
| Recurrence of CVE/SE | 7 (2.5) | 1 (0.6) | 0.268 |
| All-cause death | 2* (0.75) | 0 (0) | 0.536 |
| Antithrombotic treatment | 0.454 | ||
| None | 14 (5.0) | 7 (4.4) | |
| SAPT | 222 (79.6) | 128 (80.0) | |
| DAPT | 17 (6.1) | 6 (3.8) | |
| AC | 25 (9.0) | 16 (10.0) | |
| SAPT+AC | 1 (0.4) | 3 (1.9) | |
| Residual shunt | 15 (5.9) | 6 (4.1) | 0.691 |
| Longest follow-up available | |||
| Recurrence of CVE/SE | 11† (3.9) | 4‡ (2.6) | 0.443 |
| Time from PFOC to recurrence (years) | 0.9 (0.1–2.1) | 6.1 (2.5–8.8) | 0.090 |
| New onset AF | 6§ (2.4) | 3§ (2.0) | 0.418 |
| PE/DVT | 3 (1.5) | 4 (3.8) | 0.183 |
| All-cause death | 3 (1.5) | 3 (1.9) | 0.697 |
| Antithrombotic treatment | 0.116 | ||
| None | 21 (7.7) | 9 (5.8) | |
| SAPT | 214 (78.1) | 124 (80.0) | |
| DAPT | 17 (6.2) | 4 (2.6) | |
| AC | 19 (6.9) | 18 (11.6) | |
| SAPT+AC | 3 (1.1) | 0 (0) | |
One case of PE and one case of cardiogenic shock after coronary artery bypass graft surgery.
Five cases of stroke; five cases of TIA; one case of SE. Two of these patients had a second recurrence (one stroke and one TIA).
Two case of stroke; two cases of TIA.
One case from the EC group and the three cases from DC permanently remained in AF after PFOC.
AC, anticoagulation; AF, atrial fibrillation; CVE/SE, cerebrovascular event or systemic embolism; DAPT, dual antiplatelet therapy; DCdelayed closureDVT, deep vein thrombosis; ECearly closure PE, pulmonary embolism; PFOCpatent foramen ovale closureSAPT, single antiplatelet therapy; SE, systemic embolism; TIA, transient ischaemic attack; TOE, transoesophageal echocardiography