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. 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 3. Composite Outcomes and Recurrent Ischemic Stroke (Intention-to-treat Analyses).

Analysis Outcome Rate Log-rank Test Cox PH Model Covariate-adjusted Cox PH Model*
Device Closure Medical Therapy p Value HR (95% CI) p Value HR (95% CI) p Value
Analyses using data from all 3 trials (N = 2,303)
Primary composite outcome 1.5 (45/3,057) 2.3 (63/2,792) 0.0517 0.69 (0.47-1.01) 0.0531 0.68 (0.46-1.00) 0.0491
Recurrent ischemic stroke 0.7 (22/3,099) 1.3 (36/2,839) 0.0407 0.58 (0.34-0.98) 0.0433 0.58 (0.34-0.99) 0.0443
Secondary composite outcome (ischemic stroke, TIA, early death) 1.4 (43/3,057) 2.2 (61/2,792) 0.0488 0.68 (0.46-1.00) 0.0502 0.67 (0.45-1.00) 0.0473
Analyses limited to occluder device trials (N = 1,394)
Primary composite outcome 1.0 (22/2,274) 1.6 (32/2,021) 0.0885 0.63 (0.36-1.08) 0.0914 0.64 (0.37-1.11) 0.1150
Recurrent ischemic stroke 0.4 (10/2,301) 1.1 (23/2,044) 0.0103 0.39 (0.19-0.82) 0.0133 0.41 (0.20-0.88) 0.0213
Secondary composite outcome (ischemic stroke, TIA, early death) 0.9 (20/2,274) 1.6 (32/2,021) 0.0451 0.57 (0.33-1.00) 0.0480 0.59 (0.33-1.03) 0.0651

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

*

Adjusted for age, sex, race, coronary artery disease, diabetes, hypertension, hyperlipidemia, prior stroke, smoking status, index event (stroke versus TIA), hypermobile septum, and PFO shunt size (large versus small).

Adjusted HRs were estimated using Cox PH models combined from 10 multiply imputed datasets. In meta-analyses, source study was included in the model as a stratification term.

Excludes data from the CLOSURE trial.

CI = confidence interval; HR = hazard ratio; PH = proportional hazards; other abbreviations as in Table 1.