. Author manuscript; available in PMC: 2017 Mar 1.

Published in final edited form as: J Am Coll Cardiol. 2016 Mar 1;67(8):907–917. doi: 10.1016/j.jacc.2015.12.023

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.

Table 5. Safety Outcomes (As-treated Analyses)*.

Table 5. Safety Outcomes (As-treated Analyses)^*.