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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 1. Patient Characteristics Across Individual Trials.

Variables TOTAL (N = 2,303) CLOSURE (n = 909) PC Trial (n = 414) RESPECT (n = 980) p Value*

% of data in meta-analysis 100% 39% 18% 43% CLOSURE vs. PC Trial vs. RESPECT

Demographic variables

Age 45.3 ± 9.7 (2,291) 45.5 ± 9.3 (909) 44.5 ± 10.2 (414) 45.4 ± 9.8 (968) 0.1789
Male 52.7 (1,213/2,303) 51.8 (471/909) 49.8 (206/414) 54.7 (536/980) 0.1935
Body mass index 27.9 ± 5.7 (1,305) 28.4 ± 5.9 (834) 26.5 ± 5.2 (391) 29.4 ± 5.6 (80) <0.0001
Current smoker 15.9 (367/2,301) 15.2 (138/907) 23.9 (99/414) 13.3 (130/980) <0.0001

Medical history variables

Coronary artery disease 2.43 (56/2,303) 2.09 (19/909) 1.93 (8/414) 2.96 (29/980) 0.3622
Diabetes 6.73 (155/2,303) 7.81 (71/909) 2.66 (11/414) 7.45 (73/980) 0.0012
Hypercholesterolemia 39.1 (900/2,303) 44.1 (401/909) 27.1 (112/414) 39.5 (387/980) <0.0001
Hypertension 30.3 (697/2,303) 31.0 (282/909) 25.8 (107/414) 31.4 (308/980) 0.0950
Migraine 33.4 (770/2,303) 33.6 (305/909) 20.5 (85/414) 38.8 (380/980) <0.0001
Prior stroke/TIA 19.6 (451/2,303) 12.5 (114/909) 37.4 (155/414) 18.6 (182/980) <0.0001

Echocardiographic variables

Hypermobile septum 33.4 (758/2,267) 35.6 (311/873) 23.7 (98/414) 35.6 (349/980) <0.0001
Large PFO 61.1 (1,292/2,115) 61.1 (475/777) 21.7 (80/369) 76.1 (737/969) <0.0001

Index event variables

Index event of stroke 89.0 (2,047/2,303) 72.0 (653/907) 100 (414/414) 100 (980/980) <0.0001
Superficial stroke 56.5 (995/1,761) 37.0 (289/782) Not available 72.1 (706/979) <0.0001
Baseline NIHSS 0.7 ± 1.5 (1,882) 0.6 ± 1.2 (904) Not available 0.8 ± 1.7 (978) <0.0100
Baseline Rankin 0.7 ± 0.8 (1,882) 0.5 ± 0.8 (902) Not available 0.8 ± 0.8 (980) <0.0001

Treatment variables

Randomized to device closure 49.9 (1,150/2,303) 49.2 (447/909) 49.3 (204/414) 50.9 (499/980) 0.7185
Treated with antiplatelets only 85.2 (1,917/2,250) 84.7 (770/909) 80.0 (331/414) 88.0 (816/927) 0.0005

Values are mean ± SD (n of patients with available data) or % (n/N of patients with available data).

*

p values testing the null hypothesis of no difference between the 3 groups; obtained either from an analysis of variance F-test (age, body mass index) or from a chi-square test otherwise.

Findings on transesophageal echocardiography.

Among medical arm patients

NIHSS = National Institutes of Health Stroke Scale; PFO = patent foramen ovale; TIA = transient ischemic attack.