Table 2.
Outcomes: Stroke and/or TIA Recurrence in the Shunt Versus the No-Shunt Group
| Outcome* | No-Shunt Group (n = 835) | Shunt Group (n = 243) | Unadjusted | Adjusted† | ||||
|---|---|---|---|---|---|---|---|---|
| Events, n | Event Rate per 100 Patient-Years | Events, n | Event Rate per 100 Patient-Years | HR (95% CI) | P Value | HR (95% CI) | P Value | |
| Recurrent ischemic stroke/TIA | 24 | 0.75 | 18 | 2.32 | 3.05 (1.65–5.62) | <0.001 | 3.01 (1.59–5.69) | <0.001 |
| Ischemic stroke | 13 | 0.40 | 10 | 1.29 | 3.16 (1.38–7.21) | 0.006 | 3.33 (1.41–7.84) | 0.006 |
| Cryptogenic‡ | 3 | 0.09 | 7 | 0.90 | 9.62 (2.48–37.27) | 0.001 | 10.17 (2.54–40.64) | 0.001 |
| Noncryptogenic‡§ | 10 | 0.31 | 3 | 0.39 | 1.23 (0.34–4.47) | 0.75 | 1.26 (0.33–4.83) | 0.73 |
| TIA | 11 | 0.34 | 8 | 1.03 | 2.92 (1.17–7.25) | 0.021 | 2.66 (1.02–6.91) | 0.045 |
HR = hazard ratio; TIA = transient ischemic attack.
Outcome is the first event to occur in patients after patent foramen ovale closure.
All values were adjusted for age; study period; device; presence or absence of atrial septal aneurysm, hypertension, hyperlipidemia, diabetes, hypercoagulable state, and hypermobile septum; and medication use (aspirin, clopidogrel, warfarin) by using the propensity score method.
Recurrent ischemic strokes were adjudicated as cryptogenic or noncryptogenic according to TOAST (Trial of Org 10172 in Acute Stroke Treatment) criteria.
Includes 7 patients with cardioembolism, 1 patient with large artery atherosclerosis, 4 patients with small vessel occlusion, and 1 patient with trauma.