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A total of 707 patients were randomized into the PROTECT AF clinical trial. The patient baseline demographic and risk factors of the randomized cohort are listed below and demonstrate that patients in the two treatment groups are comparable.
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Characteristic
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WATCHMAN
N=463
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CONTROL
N=244
|
|
Age (years)
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71.7
|
72.7
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Gender
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Female
Male
|
137/463
326/463
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29.6%
70.4%
|
73/244
171/244
|
29.9%
70.1%
|
|
CHADS2 Score
|
2.2
|
2.3
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Congestive Heart Failure
History of Hypertension<
Age ≥ 75
Diabetes
Prior Stroke or TIA
|
124/463
412/463
190/463
113/463
82/463
|
26.8%
89.0%
41.0%
24.4%
17.7%
|
66/244
220/244
115/244
72/244
49/244
|
27.0%
90.2%
47.1%
29.5%
20.1%
|
|
AF Pattern:
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Paroxysmal
Persistent
Permanent
Unknown
|
200/463
97/463
160/463
6/463
|
43.2%
21.0%
34.6%
1.3%
|
99/244
50/244
93/244
2/244
|
40.6%
20.5%
38.1%
0.8%
|
|
LVEF (%)
|
57.3
|
56.7
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Over 80% of patients in both treatment groups were enrolled with a CHADS2 score of 3 or lower out of a possible score of 6. The two most common risk factors in the study based on the CHADS2 criteria were history of hypertension and age ≥ 75 years. Paroxysmal AF, defined as an intermittent form of atrial fibrillation that is characterized by a sudden onset and abrupt cessation of this rhythm, was the most common presenting rhythm of subjects in both groups.
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