Table 2.
Study characteristics and baseline characteristics of participants
| CLOSURE | PC | RESPECT | ||||
|---|---|---|---|---|---|---|
|
Study Characteristics | ||||||
|
Design |
Randomized Controlled trial |
Randomized Controlled trial |
Randomized Controlled trial |
|||
|
Duration of follow up |
2.0 years |
4.1 years |
2.1 years |
|||
|
Location |
Multi-center trial (North America) |
Multi-center trial (Europe, Canada, Brazil, Australia) |
Multi-center trial (North America) |
|||
|
Total |
909 |
414 |
980 |
|||
| |
Closure |
Medical |
Closure |
Medical |
Closure |
Medical |
| 447 |
462 |
204 |
210 |
499 |
481 |
|
|
Participants | ||||||
|
Age |
46.3+/−9.6 |
45.7+/−9.1 |
44.3+/−10.2 |
44.6+/−10.1 |
45.7+/−9.7 |
46.2+/−10.0 |
|
Male sex |
52.1% |
51.5% |
45.1% |
54.3% |
53.7% |
55.7% |
|
Race or ethnic group | ||||||
|
Asian |
1.6% |
1.7% |
NA |
NA |
NA |
NA |
|
Black |
4.2% |
5.6% |
NA |
NA |
NA |
NA |
|
White |
89.0% |
89.6% |
NA |
NA |
NA |
NA |
|
Hispanic |
6.7% |
4.8% |
NA |
NA |
NA |
NA |
|
Smoking during previous year |
21.5% |
22.6% |
22.5% |
22.4% |
15.0% |
11.4% |
|
Birth control/HRT |
NA |
NA |
NA |
NA |
8.2% |
10.8% |
|
Deep venous thrombosis |
NA |
NA |
NA |
NA |
4.0% |
3.1% |
|
Medical history (%) | ||||||
|
Hypertension |
33.8% |
28.4% |
24.0% |
27.6% |
31.7% |
31.2% |
|
Hypercholesterolemia |
47.4% |
40.9% |
24.5% |
29.5% |
38.9% |
40.1% |
|
Diabetes Mellitus |
NA |
NA |
2.5% |
2.9% |
6.6% |
8.3% |
|
Migraine |
NA |
NA |
23% |
18.1% |
39.1% |
38.5% |
|
Family history of cardiovascular disease or cerebrovascular accidents |
55.3% |
55.6% |
26.0% |
19.0% |
27.3% |
22.5% |
|
Congestive Heart Failure |
0.4% |
0% |
NA |
NA |
0.6% |
0% |
|
Ischemic heart disease |
1.3% |
0.9% |
2.0% |
1.9% |
3.8% |
1.9% |
|
Myocardial infarction |
1.6% |
1.1% |
1.5% |
0.5% |
1.0% |
0.4% |
|
Valvular dysfunction |
11.0% |
9.7% |
3.9% |
2.4% |
NA |
NA |
|
Arrhythmia |
5.8% |
4.1% |
NA |
NA |
NA |
NA |
|
Peripheral vascular disease |
1.1% |
1.5% |
1.5% |
1.0% |
1.0% |
0.2% |
|
Pulmonary embolus |
0 |
0.9% |
NA |
NA |
NA |
NA |
|
Peripheral embolism |
NA |
NA |
2.9% |
2.4% |
NA |
NA |
|
Previous TIA |
NA |
NA |
NA |
NA |
11.6% |
12.7% |
|
Previous Stroke |
NA |
NA |
NA |
NA |
10.6% |
10.6% |
|
Index neurologic event for study entry | ||||||
|
Stroke |
NA |
NA |
80.9% |
77.6% |
NA |
NA |
|
Cryptogenic stroke |
72.6% |
71.4% |
NA |
NA |
100.0% |
100.0% |
| TIA | 27.4% | 28.6% | 16.2% | 20.0% | NA | NA |