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 |
|
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| 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 |
|
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| 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 |
|
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| 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.