Table 5. Safety Outcomes (As-treated Analyses)*.
Safety Outcomes | Device Closure | Medical Therapy | HR * (95% CI) p Value† |
---|---|---|---|
Analyses using data from all 3 trials (n = 2,281) | n = 1,067 | n = 1,214 | |
Bleeding | 3.7 (11/2,990) | 3.7 (11/2,941) | 1.11 (0.48-2.56) 0.81 |
Atrial fibrillation | 1.44 (42/2,915) | 0.48 (14/2,936) | 3.22 (1.76-5.90) 0.0002 |
Analyses limited to occluder device trials (n = 1,372) ‡ | n = 663 | n = 709 | |
Bleeding | 0.09 (2/2,240) | 0.14 (3/2,131) | 0.68 (0.11-4.09) 0.67 |
Atrial fibrillation | 0.87 (19/2,190) | 0.47 (10/2,119) | 1.85 (0.86-3.98) 0.12 |
Values are % per person-year (events/total person-years) unless otherwise indicated.
Unadjusted HRs and p values from Cox PH model; source study was included in the model as a stratification term.
See Table 3 for the data included in as-treated analyses. Data for procedural complications were abstracted from the original study publications (see Appendix) and not available for as-treated analysis.
Excludes data from the CLOSURE trial.
Abbreviations as in Table 3.