Table 4

Composite Outcomes and Recurrent Stroke (As-Treated Analyses)

Outcome RateLog-Rank p ValueCox PH ModelCovariate-Adjusted Cox PH Model
Device ClosureMedical TherapyHR (95% CI),
p Value
HR (95% CI),
p Value
Analyses Using Data From All 3 Trials (N = 2,281)
Primary composite outcome1.4 (40/2,948)2.3 (66/2,877)0.0250.64 (0.43–0.95), 0.0260.63 (0.43–0.94), 0.025
Recurrent ischemic stroke0.6 (19/2,985)1.3 (37/2,929)0.0230.53 (0.30–0.92), 0.0250.53 (0.30–0.92), 0.025
Secondary composite outcome (ischemic stroke, TIA, early death)1.3 (38/2,948)2.2 (64/2,877)0.0220.63 (0.42–0.94), 0.0230.63 (0.42–0.94), 0.023
Analyses Limited to Disc Occluder Device Trials (i.e., RESPECT and PC Trial) (n = 1,372)
Primary composite outcome0.8 (18/2,207)1.7 (34/2,063)0.0180.51 (0.29–0.90), = 0.0200.51 (0.29–0.91), 0.022
Recurrent ischemic stroke0.3 (7/2,230)1.2 (24/2,091)0.0010.28 (0.12–0.64), 0.0030.28 (0.12–0.66), 0.004
Secondary composite outcome (ischemic stroke, TIA, early death)0.7 (16/2,207)1.7 (34/2,063)0.0070.45 (0.25–0.82), 0.0090.45 (0.25–0.83), 0.010

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

Abbreviations as in Tables 1 and 3.

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