Table 5

Safety Outcomes (As-Treated Analyses)

Device ClosureMedical TherapyHR (95% CI),
p Value
Analyses using data from all 3 trials (n = 2,281)1,0671,214
 Bleeding3.7 (11/2,990)3.7 (11/2,941)1.11 (0.48–2.56), 0.81
 Atrial fibrillation1.44 (42/2,915)0.48 (14/2,936)3.22 (1.76–5.90), 0.0002
Analyses limited to disc occluder device trials (n = 1,372)663709
 Bleeding0.09 (2/2,240)0.14 (3/2,131)0.68 (0.11–4.09), 0.67
 Atrial fibrillation0.87 (19/2,190)0.47 (10/2,119)1.85 (0.86–3.98), 0.12

Values are n or % per person-year (events/total person-years) unless otherwise indicated.

Abbreviations as in Table 3.

  • 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.