Table 3. Primary and Secondary Efficacy Outcomes.
| Device | Medical therapy | 2-y Absolute difference, ARR, % (95% CI)a | Unadjusted relative risk, HR (95% CI) | Adjusted relative riskb | ||||
|---|---|---|---|---|---|---|---|---|
| Overall outcome rate events per 100 person-years (95% CI) | Events/No. of patients | Overall outcome rate events per 100 person-years (95% CI) | Events/No. of patients | HR (95% CI) | P value | |||
| Primary efficacy outcome | ||||||||
| Recurrent ischemic stroke | 0.47 (0.35 to 0.65) | 39/1889 | 1.09 (0.88 to 1.36) | 82/1851 | 1.72 (0.73 to 2.72) | 0.42 (0.29 to 0.62) | 0.41 (0.28 to 0.60) | <.001 |
| Secondary efficacy outcomes (in hierarchical order) | ||||||||
| 1. PFO-associated recurrent ischemic strokec | 0.24 (0.15 to 0.40) | 16/1238 | 0.90 (0.69 to 1.18) | 53/1179 | 2.21 (1.08 to 3.34) | 0.25 (0.14 to 0.45) | 0.24 (0.14 to 0.43) | <.001 |
| 2. Recurrent ischemic stroke or early all-cause mortality | 0.47 (0.35 to 0.65) | 39/1889 | 1.09 (0.88 to 1.36) | 82/1851 | 1.72 (0.73 to 2.72) | 0.42 (0.29 to 0.62) | 0.41 (0.28 to 0.60) | <.001 |
| 3. Recurrent ischemic stroke, early all-cause mortality, or vascular death | 0.55 (0.41 to 0.73) | 45/1889 | 1.15 (0.93 to 1.42) | 86/1851 | 1.62 (0.60 to 2.64) | 0.45 (0.32 to 0.65) | 0.44 (0.31 to 0.64) | <.001 |
| 4. Recurrent ischemic stroke, TIA, or vascular death | 1.08 (0.88 to 1.34) | 88/1889 | 1.72 (1.44 to 2.04) | 127/1851 | 1.61(0.27 to 2.96) | 0.61 (0.46 to 0.80) | 0.60 (0.45 to 0.79) | <.001 |
| 5. Disability-worsening recurrent ischemic stroked | 0.16 (0.09 to 0.27) | 13/1685 | 0.27 (0.17 to 0.41) | 20/1641 | 0.18 (−0.39 to 0.75) | 0.62 (0.31 to 1.25) | 0.59 (0.37 to 1.22) | .14 |
Abbreviations: ARR, absolute risk reduction (medical therapy - device); HR, hazard ratio; PFO, patent foramen ovale; TIA, transient ischemic attack.
Absolute difference calculated as differences in Kaplan-Meier event rates at 2 years.
Accounting for age, sex, prior myocardial infarction, diabetes, hypertension, hyperlipidemia, prior stroke or TIA, smoking status, index event (stroke vs TIA), atrial septal aneurysm, PFO shunt size (large vs small, definition in eAppendix 5 and eTables 3 and 4 in the Supplement), and superficial infarction on neuroimaging (present vs absent).
No data for the PC and CLOSURE Trials.
Assume missing outcome is not disabling (no data for PC Trial). Median time to the primary outcome of recurrent ischemic stroke was 13.7 months (IQR, 4.8-29.7; n = 121).