Table 4.
Serious Adverse Events During the Periprocedural Period, Excluding Stroke, MI, and Death.
| Overall (n=2502) |
Symptomatic (n=1321) |
Asymptomatic (n=1181) |
||||
|---|---|---|---|---|---|---|
| Clinical Status Procedure |
CAS (n=1262) |
CEA (n=1240) |
CAS (n=668) |
CEA (n=653) |
CAS (n=594) |
CEA (n=587) |
| Surgical wound complication | ||||||
| Hematoma requiring treatment | 0 | 19 | 0 | 8 | 0 | 11 |
| Other | 3* | 20 | 3 | 8 | 0 | 12 |
| Bleeding Events† | ||||||
| Transfusion required | 24 | 12 | 16 | 5 | 8 | 7 |
| Hematoma requiring treatment | 8 | 0 | 6 | 0 | 2 | 0 |
| Retroperitoneal hemorrhage | 4 | 0 | 4 | 0 | 0 | 0 |
| Bleeding moderate | 4 | 2 | 2 | 0 | 2 | 2 |
| Bleeding Minor | 5 | 1 | 3 | 0 | 2 | 1 |
| Femoral artery complications, nonhemorrhagic | 10 | 3 | 6 | 2 | 4 | 1 |
| Cranial nerve palsies | 4* | 58 | 3 | 33 | 1 | 25 |
| Hypotension‡ | 53 | 24 | 30 | 13 | 23 | 11 |
| Hypertension | 17 | 55 | 8 | 32 | 9 | 23 |
| Bradycardia | ||||||
| Requiring permanent pacemaker | 6 | 0 | 2 | 0 | 4 | 0 |
| Atropine or no treatment | 35 | 6 | 18 | 4 | 17 | 2 |
Three of these patients were randomized to CAS who underwent endarterectomy.
Categories not mutually exclusive.
Systolic blood pressure ≤80 mm Hg or pressors administrated ≥24 hours.