Table 4.
Adverse event rates - n (%) | All asymptomatic patients 1180* (100%) |
CREST-2 trial ineligible 916 (77.6%) |
CREST-2 trial eligible 264 (22.4%) |
---|---|---|---|
Stroke or death | 16 (1.4) | 14 (1.5) | 2 (0.8) |
Any stroke, regardless of laterality | 12 (1.0) | 11 (12) | 1 (0.4) |
Stroke ipsilateral to the index artery | 9 (0.8) | 8 (0.9) | 1 (0.4) |
Stroke contralateral to the index artery | 5 (0.4) | 5 (0.6) | 0 (0) |
Death | 4 (0.3) | 3 (0.3) | 1 (0.4) |
Stroke, death, or myocardial infarction | 18 (1.5) | 16 (1.8) | 2 (0.8) |
Myocardial infarction (MI) | 2 (0.2) | 2 (0.2) | 0 (0) |
Stroke, death, MI, or major† access site complications | 27 (2.3) | 23 (2.5) | 4 (1.5) |
Major access site complications | 9 (0.8) | 7 (0.8) | 2 (0.8) |
1180 asymptomatic patients out of the total 2141 C2R patients with primary atherosclerosis
Access site complications are considered major if there is a need for blood transfusion or surgical evacuation/repair